menu
    • menu

    Find Biotin manufacturers, exporters & distributors on PharmaCompass

    Basic Nutrition D biotin

    Virtual Booth

    Contact Supplier

    dksh-m-2025-05-26

    Virtual Booth

    Contact Supplier

    dmfs-not-supported-m-2025-05-19

    Virtual Booth

    Contact Supplier

    TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

    Virtual Booth

    Contact Supplier

    LEBSA- Your strategic API source for niche molecules.

    Virtual Booth

    Contact Supplier

    jdmfs-not-supported-m-2025-04-28

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    PharmaCompass

    Synopsis

    Related ProductsRelated Products

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    31

    API Suppliers

    API Suppliers

    6

    USDMF

    US DMFs Filed

    2

    CEP/COS

    CEP/COS Certifications

    2

    JDMF

    JDMFs Filed

    0

    EU WC

    EU WC

    1

    KDMF

    KDMF

    11

    NDC API

    NDC API

    0

    VMF

    NDC API

    15

    Listed Suppliers

    Other Suppliers

    0INTERMEDIATES

    REF. STANDARDS OR IMPURITIES

    1

    EDQM

    1

    USP

    0

    JP

    1

    Others

    FINISHED DOSAGE FORMULATIONS

    100

    FDF Dossiers

    FDF Dossiers

    15

    FDA Orange Book

    FDA (Orange Book)

    13

    Europe

    Europe

    24

    Canada

    Canada

    0

    Australia

    Australia

    21

    South Africa

    South Africa

    27

    Listed Dossiers

    Listed Dossiers

    3DRUGS IN DEVELOPMENT

    FDF DossiersDRUG PRODUCT COMPOSITIONS

    424RELATED EXCIPIENT COMPANIES

    714EXCIPIENTS BY APPLICATIONS

    PATENTS & EXCLUSIVITIES

    0

    US Patents

    0

    US Exclusivities

    0

    Health Canada Patents

    API REF. PRICE (USD/KG)

    $
    $ 526

    GLOBAL SALES INFORMATION

    US Medicaid

    NA

    Annual Reports

    NA

    Regulatory FDF Prices

    Listed Dossiers
    API/FDF Prices: Book a Demo to
    explore the features and consider
    upgrading later

    MARKET PLACE

    40

    API

    2

    FDF

    DIGITAL CONTENT

    1

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    3

    News #PharmaBuzz

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: D-biotin, 58-85-5, Vitamin h, Vitamin b7, Coenzyme r, Bioepiderm
    Molecular Formula
    C10H16N2O3S
    Molecular Weight
    244.31  g/mol
    InChI Key
    YBJHBAHKTGYVGT-ZKWXMUAHSA-N
    FDA UNII
    6SO6U10H04
    Biotin
    A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.
    1 2D Structure

    Biotin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[(3aS,4S,6aR)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl]pentanoic acid
    2.1.2 InChI
    InChI=1S/C10H16N2O3S/c13-8(14)4-2-1-3-7-9-6(5-16-7)11-10(15)12-9/h6-7,9H,1-5H2,(H,13,14)(H2,11,12,15)/t6-,7-,9-/m0/s1
    2.1.3 InChI Key
    YBJHBAHKTGYVGT-ZKWXMUAHSA-N
    2.1.4 Canonical SMILES
    C1C2C(C(S1)CCCCC(=O)O)NC(=O)N2
    2.1.5 Isomeric SMILES
    C1[C@H]2[C@@H]([C@@H](S1)CCCCC(=O)O)NC(=O)N2
    2.2 Other Identifiers
    2.2.1 UNII
    6SO6U10H04
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Biodermatin

    2. Biokur

    3. Biotin Gelfert

    4. Biotin Hermes

    5. Biotin Ratiopharm

    6. Biotin-ratiopharm

    7. Biotine Roche

    8. Deacura

    9. Gabunat

    10. Gelfert, Biotin

    11. Hermes, Biotin

    12. Medebiotin

    13. Medobiotin

    14. Roche, Biotine

    15. Rombellin

    16. Vitamin H

    2.3.2 Depositor-Supplied Synonyms

    1. D-biotin

    2. 58-85-5

    3. Vitamin H

    4. Vitamin B7

    5. Coenzyme R

    6. Bioepiderm

    7. Bios Ii

    8. Factor S

    9. D(+)-biotin

    10. Biodermatin

    11. D-(+)-biotin

    12. Medebiotin

    13. (+)-biotin

    14. Biotinum

    15. Biotine

    16. Meribin

    17. Factor S (vitamin)

    18. Lutavit H2

    19. Biotina

    20. 3h-biotin

    21. Nsc 63865

    22. Ccris 3932

    23. Hsdb 346

    24. Ritatin

    25. Injacom H

    26. 5-((3as,4s,6ar)-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid

    27. Cis-hexahydro-2-oxo-1h-thieno(3,4)imidazole-4-valeric Acid

    28. Cis-tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric Acid

    29. L-biotin

    30. 1swk

    31. 1swn

    32. 1swr

    33. Mfcd00005541

    34. Rovimix H 2

    35. D-biotin Factor S

    36. 5-[(3as,4s,6ar)-2-oxo-hexahydro-1h-thieno[3,4-d]imidazolidin-4-yl]pentanoic Acid

    37. Ai3-51198

    38. 5-[(3as,4s,6ar)-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl]pentanoic Acid

    39. 5-[(3as,4s,6ar)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl]pentanoic Acid

    40. Cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valeric Acid

    41. (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valeric Acid

    42. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-valeric Acid

    43. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as-(3aalpha,4beta,6aalpha))-

    44. 2'-keto-3,4-imidazolido-2-tetrahydrothiophene-n-valeric Acid

    45. Chebi:15956

    46. 6so6u10h04

    47. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)-

    48. Nsc-63865

    49. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoic Acid, (3as-(3aalpha,4beta,6aalpha))-

    50. 22377-59-9

    51. D-biotin 10 Microg/ml In Acetonitrile

    52. Md-1003

    53. Beta-biotin

    54. Biotin Impurity D - Mixture Of Diastereomers

    55. Dsstox_cid_2679

    56. Vitamin Bw

    57. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valeric Acid

    58. (3as-(3aalpha,4b,6aalpha))-hexahydro-2-oxo-1h-thieno(3,4-d)imidaz- Ole-4-pentanoic Acid

    59. Dsstox_rid_76688

    60. Dsstox_gsid_22679

    61. Medobiotin

    62. Deacura

    63. Gabunat

    64. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoic Acid

    65. Rombellin

    66. Biokur

    67. Biotine [inn-french]

    68. Biotinum [inn-latin]

    69. Biotina [inn-spanish]

    70. Biotin Gelfert

    71. Biotin Hermes

    72. Biotine Roche

    73. Gelfert, Biotin

    74. Biotin Ratiopharm

    75. Biotin-ratiopharm

    76. Hermes, Biotin

    77. Roche, Biotine

    78. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)-

    79. 5-((3as,4s,6ar)-rel-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid

    80. Smr000112255

    81. D(+)biotin

    82. 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid

    83. Einecs 200-399-3

    84. Biotin [usp:inn:jan]

    85. Hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-pentanoic Acid

    86. Unii-6so6u10h04

    87. Delta-biotin

    88. Vitamin-h

    89. 1avd

    90. 1ndj

    91. 1stp

    92. 1swg

    93. 1swp

    94. 2avi

    95. 4bcs

    96. 4ggz

    97. 4jnj

    98. Bioepiderm (tn)

    99. Cas-58-85-5

    100. Bios H

    101. Ncgc00094984-04

    102. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, [3as-(3aalpha,4beta,6aalpha)]-

    103. Biotin111in

    104. Delta-(+)-biotin

    105. Biotin (8ci)

    106. Delta-biotin Factor S

    107. 1df8

    108. 1n9m

    109. 2gh7

    110. 3t2w

    111. 4bj8

    112. Biotin [vandf]

    113. Biotin [hsdb]

    114. Biotin [inci]

    115. Biotin [fcc]

    116. Biotin [inn]

    117. Biotin [jan]

    118. Biotin [usp-rs]

    119. Biotin [who-dd]

    120. Prestwick0_000418

    121. Prestwick1_000418

    122. Prestwick2_000418

    123. Prestwick3_000418

    124. Biotin [mi]

    125. Biotin [mart.]

    126. Cid_253

    127. D-biotin [vandf]

    128. Bdbm12

    129. Biotin Silver Nanoparticles

    130. Bmse000227

    131. Chembl857

    132. Probes2_000006

    133. Schembl8763

    134. Biotin [ep Impurity]

    135. Biotin [orange Book]

    136. Biotin For System Suitability

    137. Bspbio_000376

    138. 22879-79-4

    139. Biotin (jp17/usp/inn)

    140. Mls001066402

    141. Mls001074888

    142. Mls001331736

    143. Mls001333089

    144. Biotin [ep Monograph]

    145. D-biotin, Analytical Standard

    146. Spbio_002315

    147. Biotin [usp Monograph]

    148. Bpbio1_000414

    149. Cid_171548

    150. Gtpl4787

    151. Amf0005

    152. 1n43

    153. 2f01

    154. Biotin, >=99.0% (t)

    155. Hms1569c18

    156. Hms2096c18

    157. Hms2271o06

    158. Hms3713c18

    159. Hy-b0511

    160. Tox21_113050

    161. Tox21_302161

    162. Ac8089

    163. Bbl028095

    164. Biotin, Tested According To Ph.eur.

    165. S3130

    166. Stk801941

    167. Zinc35024346

    168. Akos001287669

    169. Tox21_113050_1

    170. Ccg-220418

    171. Db00121

    172. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as-(3aalpha,4b,6aalpha))-

    173. Biotin, Meets Usp Testing Specifications

    174. Biotin, Saj Special Grade, >=98.0%

    175. Ncgc00179580-01

    176. Ncgc00179580-02

    177. Ncgc00179580-04

    178. Ncgc00255377-01

    179. 56846-45-8

    180. Ac-19998

    181. Bp-20441

    182. Biotin, >=99% (tlc), Lyophilized Powder

    183. Biotin, Vetec(tm) Reagent Grade, >=99%

    184. Ab00374191

    185. B0463

    186. 58b855

    187. C00120

    188. D00029

    189. M02926

    190. Ab00374191-08

    191. Ab00374191_11

    192. A929752

    193. Biotin, Plant Cell Culture Tested, >=99% (tlc)

    194. Q181354

    195. Sr-01000765521

    196. Biotin, Certified Reference Material, Tracecert(r)

    197. Q-200929

    198. Sr-01000765521-2

    199. Brd-k89210380-001-03-8

    200. Brd-k89210380-001-13-7

    201. 6ae43aa3-bc3d-4c49-9db9-5913a2401eb6

    202. Biotin, European Pharmacopoeia (ep) Reference Standard

    203. F2173-0855

    204. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoate

    205. Z210803762

    206. Biotin, United States Pharmacopeia (usp) Reference Standard

    207. Cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valerate

    208. (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valerate

    209. 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoate

    210. Daunorubicin Hydrochloride, Antibiotic For Culture Media Use Only

    211. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valerate

    212. Biotin, Pharmaceutical Secondary Standard; Certified Reference Material

    213. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)- (9ci)

    214. 5-((3ar,6s,6as)-2-oxo-hexahydro-thieno[3,4-d]imidazol-6-yl)-pentanoic Acid

    215. 5-[(3ar,6s,6as)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-6-yl]pentanoic Acid

    216. Biotin For System Suitability, European Pharmacopoeia (ep) Reference Standard

    217. Hexahydro-2-oxo-[3as-(3aa,4b,6aa)]-1h-thieno[3,4-d]imidazole-4-pentanoate

    218. Hexahydro-2-oxo-[3as-(3aa,4b,6aa)]-1h-thieno[3,4-d]imidazole-4-pentanoic Acid

    219. Hexahydro-2-oxo-[3as-(3alpha,4beta,6alpha)]-1h-thieno[3,4-d]imidazole-4-pentanoate

    220. Hexahydro-2-oxo-[3as-(3alpha,4beta,6alpha)]-1h-thieno[3,4-d]imidazole-4-pentanoic Acid

    221. Biotin, Pharmagrade, Usp, Meets Fcc Testing Specifications, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production.

    222. Biotin, Powder, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture, Suitable For Plant Cell Culture, >=99%

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 244.31 g/mol
    Molecular Formula C10H16N2O3S
    XLogP30.3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass244.08816355 g/mol
    Monoisotopic Mass244.08816355 g/mol
    Topological Polar Surface Area104 Ų
    Heavy Atom Count16
    Formal Charge0
    Complexity298
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    The B vitamins are indicated for prevention and treatment of vitamin B deficiency. Vitamin B deficiency may occur as a result of inadequate nutrition or intestinal malabsorption but does not occur in healthy individuals receiving an adequate balanced diet. Simple nutritional deficiency of individual B vitamins is rare since dietary inadequacy usually results in multiple deficiencies. For prophylaxis of biotin deficiency, dietary improvement, rather than supplementatin, is advisable. For teatment of biotin deficiency, supplementation is preferred. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Large doses of biotin ... are administered to babies with infantile seborrhea and to individuals with genetic alterations of biotin-dependent enzymes. patients who receive long-term parenteral nutrition should be given vitamin formulations that contain biotin.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1763

    (VET): Biotin is used as a feed additive for poultry and swine.

    Kirk-Othmer Encyclopedia of Chemical Technology. 3rd ed., Volumes 1-26. New York, NY: John Wiley and Sons, 1978-1984., p. V24 41

    Biotin is used to treat the biotin-responsive inborn errors of metabolism holocarboxylase synthetase deficiency and biotinidase deficiency. Holocarboxylase deficiency is the most common cause of neonatal multiple carboxylase deficiency. Biotinidase deficiency is the most common cause of late-onset multiple carboxylase deficiency.

    Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)

    For more Therapeutic Uses (Complete) data for BIOTIN (11 total), please visit the HSDB record page.

    4.2 Drug Warning

    Biotin deficiency, which can occur by the feeding of uncooked egg whites or by the omission of biotin from the diet, can cause alopecia and a characteristic scaly, erythematous dermatitis around body orifices in infants, children, and adults. For adults, prolonged biotin deficiency can result in depression, lethargy, hallucinations, and paresthesias of the extremities.

    PMID:11800048 Fiume MZ, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 20 (Suppl 4):1-12 (2001)

    Biotin has not been proven effective in the treatment of acne, seborrheic eczema, or alopecia.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    4.3 Drug Indication

    For nutritional supplementation, also for treating dietary shortage or imbalance.

    Treatment of multiple sclerosis

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Biotin is a water-soluble B-complex vitamin which is composed of an ureido ring fused with a tetrahydrothiophene ring, which attaches a valeric acid substituent at one of its carbon atoms. Biotin is used in cell growth, the production of fatty acids, metabolism of fats, and amino acids. It plays a role in the Kreb cycle, which is the process in which energy is released from food. Biotin not only assists in various metabolic chemical conversions, but also helps with the transfer of carbon dioxide. Biotin is also helpful in maintaining a steady blood sugar level. Biotin is often recommended for strengthening hair and nails. Consequenty, it is found in many cosmetic and health products for the hair and skin. Biotin deficiency is a rare nutritional disorder caused by a deficiency of biotin. Initial symptoms of biotin deficiency include: Dry skin, Seborrheic dermatitis, Fungal infections, rashes including erythematous periorofacial macular rash, fine and brittle hair, and hair loss or total alopecia. If left untreated, neurological symptoms can develop, including mild depression, which may progress to profound lassitude and, eventually, to somnolence; changes in mental status, generalized muscular pains (myalgias), hyperesthesias and paresthesias. The treatment for biotin deficiency is to simply start taking some biotin supplements. A lack of biotin in infants will lead to a condition called seborrheic dermatitis or "cradle cap". Biotin deficiencies are extremely rare in adults but if it does occur, it will lead to anemia, depression, hair loss, high blood sugar levels, muscle pain, nausea, loss of appetite and inflamed mucous membranes.

    5.2 MeSH Pharmacological Classification

    Vitamin B Complex

    A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)

    5.3 ATC Code

    A - Alimentary tract and metabolism

    A11 - Vitamins

    A11H - Other plain vitamin preparations

    A11HA - Other plain vitamin preparations

    A11HA05 - Biotin

    5.4 Absorption, Distribution and Excretion

    Absorption

    Systemic - approximately 50%

    The intestine is exposed to biotin from a few sources: the diet, biotin supplements and biotin synthesized by bacteria in the large intestine. Dietary biotin exists in free and protein-bound forms. Protein-bound biotin is digested by proteases and peptidases to biotin-containing oligopeptides and biocytin (epsilon-N-biotinyl-L-lysine). Biocytin and the biotin-containing oligopeptides are converted to biotin via the enzyme biotinidase. Biotin - both dietary-derived biotin and supplementary biotin - is efficiently absorbed from the small intestine. At doses of biotin derived from food, biotin appears to be transported into enterocytes by a sodium -dependent carrier. At higher doses of biotin,absorption appears to occur by passive diffusion. Absorption of the biotin produced by the colonic microflora, appears to occur by a carrier mediated process in the proximal large intestine.

    Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)

    Elimination: Primarily in urine.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Protein binding: Primarily to plasma proteins.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

    Absorption: approximately 50%.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

    For more Absorption, Distribution and Excretion (Complete) data for BIOTIN (32 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Biotin is excreted in the urine as biotin, bisnorbiotin, biotin sulfoxide, biotin sulfone, bisnorbiotin methyl ketone and tetranobiotin-1-sulfoxide.

    Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)

    Biotin is catabolized to a number of different metabolites, including bisnorbiotin, biotin sulfoxide, biotin sulfone, bisonorbiotin methylketone and tetranorbiotin-1-sulfoxide.

    Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)

    More than 95% of the biotin is free in the skim fraction of human milk. The concentration of biotin varies substantially in some women and exceeds that in serum by one to two order of magnitude, suggesting that there is a transport system into milk. The biotin metabolite bisnorbiotin accounts for approximately 50%. In early and transitional human milk, the biotin metabolite biotin sulfoxide accounts for about 10% of the total biotin plus metabolites. With postpartum maturation, the biotin concentration increases, but the bisnorbiotin and biotin sulfoxide concentrations still account for 25% and 8% at 5 weeks postpartum. Current studies provide no evidence for a soluble biotin-binding protein or any other mechanism that traps biotin in human milk.

    Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)

    On a molar basis, biotin accounts for approximately half of the total avidin-binding substances in human serum and urine. Biocytin, bisnorbiotin, bisnorbiotin methylketone, biotin sulfoxide, and biotin sulfone form most of the balance. Biotin metabolism is accelerated in some individuals by anticonvulsants and during pregnancy, thereby increasing the ratio of biotin metabolites to biotin excreted in urine.

    Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)

    An alternate fate to being incorporated into carboxylases or unchanged excretion is catabolism to an inactive metabolite before excretion in urine. About half of biotin undergoes metabolism before excretion. Two principal pathways of biotin catabolism have been identified in mammals. In the first pathway, the valeric acid side chain of biotin is degraded by beta oxidation. This leads to the formation of bisnorbiotin, tetranorbiotin, and related intermediates that are known to result from beta-oxidation of fatty acids. The cellular site of this beta-oxidation of biotin is uncertain. Nonenzymatic decarboxylation of the unstable beta-ketobiotin and beta-keto-bisnorbiotin leads to formation of bisnorbiotin methylketone and tetranorbiotin methylketone, which appear in urine. In the second pathway, the sulfur in the thiophane ring of biotin is oxidized, leading to the formation of biotin L-sulfoxide, biotin D-sulfoxide, and biotin sulfone. Combined oxidation of the ring sulfur and beta-oxidation of the side chain lead to metabolites such as bisnorbiotin sulfone. In mammals, degradation of the biotin ring to release carbon dioxide and urea is quantitatively minor.

    Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)

    5.6 Mechanism of Action

    Biotin is necessary for the proper functioning of enzymes that transport carboxyl units and fix carbon dioxide, and is required for various metabolic functions, including gluconeogenesis, lipogenesis, fatty acid biosynthesis, propionate metabolism, and catabolism of branched-chain amino acids.

    In human tissues biotin is a cofactor for the enzymatic carboxylation of four substrates: pyruvate, acetyl coenzyme A (CoA), propionyl CoA, and beta-methylcrotonyl CoA. As such, it plays an important role in both carbohydrate and fat metabolism. Carbon dioxide fixation occurs in a two-step reaction, the first involving binding of carbon dioxide to the biotin moiety of the holoenzyme, and the second involving transfer of the biotin-bound carbon dioxide to an appropriate acceptor.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1763

    Biotin functions in carbon dioxide fixation reactions in intermediate metabolism, transferring the carboxyl group to acceptor molecules. It acts similarly in decarboxylation reactions. Biotin is essential in human metabolism for its part in the previously described enzymatic steps, in catalyzing deamination of amino acids, and in oleic acid synthesis. Biotin is a cofactor for the enzymatic carboxylation of pyruvate, acetyl coenzyme A (CoA), propionyl CoA, and beta-methylcrotonyl CoA, and, therefore, plays an important role in carbohydrate and fat metabolism.

    PMID:11800048 Fiume MZ, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 20 (Suppl 4):1-12 (2001)

    Protein folding in the endoplasmic reticulum (ER) depends on Ca2+; uptake of Ca2+ into the ER is mediated by sarco/endoplasmic reticulum Ca2+-ATPase 3 (SERCA3). The 5'-flanking region of the SERCA3 gene (ATP2A3) contains numerous binding sites for the transcription factors Sp1 and Sp3. Biotin affects the nuclear abundance of Sp1 and Sp3, which may act as transcriptional activators or repressors. Here we determined whether biotin affects the expression of the SERCA3 gene and, thus, protein folding in human lymphoid cells. Jurkat cells were cultured in media containing 0.025 nmol/L biotin (denoted "deficient") or 10 nmol/L biotin ("supplemented"). The transcriptional activity of the full-length human SERCA3 promoter was 50% lower in biotin-supplemented cells compared to biotin-deficient cells. Biotin-dependent repressors bind to elements located 731 to 1312 bp upstream from the transcription start site in the SERCA3 gene. The following suggest that low expression of SERCA3 in biotin-supplemented cells impaired folding of secretory proteins in the ER, triggering unfolded protein response: (i) sequestration of Ca2+ in the ER decreased by 14 to 24% in response to biotin supplementation; (ii) secretion of interleukin-2 into the extracellular space decreased by 75% in response to biotin supplementation; (iii) the nuclear abundance of stress-induced transcription factors increased in response to biotin supplementation; and (iv) the abundance of stress-related proteins such ubiquitin activating enzyme 1, growth arrest and DNA damage 153 gene, X-box binding protein 1 and phosphorylated eukaryotic translation initiation factor 2alpha increased in response to biotin supplementation. Collectively, this study suggests that supplements containing pharmacological doses of biotin may cause cell stress by impairing protein folding in the ER.

    PMID:16109482 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1473219 Griffin JB et al; J Nutr Biochem 17(4):272-81 (2006)

    Evidence is emerging that biotin participates in processes other than classical carboxylation reactions. Specifically, novel roles for biotin in cell signaling, gene expression, and chromatin structure have been identified in recent years. Human cells accumulate biotin by using both the sodium-dependent multivitamin transporter and monocarboxylate transporter 1. These transporters and other biotin-binding proteins partition biotin to compartments involved in biotin signaling: cytoplasm, mitochondria, and nuclei. The activity of cell signals such as biotinyl-AMP, Sp1 and Sp3, nuclear factor (NF)-kappaB, and receptor tyrosine kinases depends on biotin supply. Consistent with a role for biotin and its catabolites in modulating these cell signals, greater than 2000 biotin-dependent genes have been identified in various human tissues. Many biotin-dependent gene products play roles in signal transduction and localize to the cell nucleus, consistent with a role for biotin in cell signaling. Posttranscriptional events related to ribosomal activity and protein folding may further contribute to effects of biotin on gene expression. Finally, research has shown that biotinidase and holocarboxylase synthetase mediate covalent binding of biotin to histones (DNA-binding proteins), affecting chromatin structure; at least seven biotinylation sites have been identified in human histones. Biotinylation of histones appears to play a role in cell proliferation, gene silencing, and the cellular response to DNA repair. Roles for biotin in cell signaling and chromatin structure are consistent with the notion that biotin has a unique significance in cell biology.

    PMID:16011464 Zempleni J; Annu Rev Nutr 25:175-96 (2005)

    CEP/COS

    read-more
    read-moreread-more

    DSM Nutritional Products Ltd. Kaise...

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Biotin

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    CEP 2001-405 - Rev 06
    Valid
    Chemical
    2024-04-22
    1073
    blank

    01

    DSM Nutritional Products Ltd. Kaise...

    Netherlands
    PharmaLytica
    Not Confirmed
    arrow

    ZHEJIANG SHENGDA BIO-PHARM CO., LTD...

    Contact Supplier
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Biotin

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      R0-CEP 2019-320 - Rev 00
      Valid
      Chemical
      2021-08-09
      1073
      blank

      02

      ZHEJIANG SHENGDA BIO-PHARM CO., LTD...

      China
      PharmaLytica
      Not Confirmed
      arrow

      ZHEJIANG SHENGDA BIO-PHARM CO., LTD...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Biotin

      Certificate Number : R0-CEP 2019-320 - Rev 00

      Status : Valid

      Issue Date : 2021-08-09

      Type : Chemical

      Substance Number : 1073

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

      JDMF

      read-more
      read-moreread-more

      01

      DSM Nutritional Products Ltd.

      Netherlands
      PharmaLytica
      Not Confirmed
      arrow

      DSM Nutritional Products Ltd.

      Netherlands
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag Netherlands
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Biotin

      Registration Number : 217MF11122

      Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland

      Initial Date of Registration : 2005-12-05

      Latest Date of Registration : 2006-11-15

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      02

      Sun Chemical Co., Ltd.

      China
      PharmaLytica
      Not Confirmed
      arrow

      Sun Chemical Co., Ltd.

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      d-biotin

      Registration Number : 217MF10344

      Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture

      Initial Date of Registration : 2005-07-27

      Latest Date of Registration : 2006-03-24

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

      KDMF

      read-more
      read-moreread-more

      01

      Zhejiang Shengda Pharmaceutical Co ...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Shengda Pharmaceutical Co ...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Biotin

      Registrant Name : Otran Korea Co., Ltd.

      Registration Date : 2021-10-19

      Registration Number : 20211019-211-J-1124

      Manufacturer Name : Zhejiang Shengda Bio-Pharm C...

      Manufacturer Address : No.789, Renmin East Road, Tiantai, Zhejiang, China, 317200

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

      NDC API

      read-more
      read-moreread-more

      01

      NURAY CHEMICALS PRIVATE LIMITED

      India
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

      Contact Supplier Contact Supplier
      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 58159-118

      Start Marketing Date : 2024-12-30

      End Marketing Date : 2026-12-31

      Dosage Form (Strength) : POWDER (35kg/35kg)

      Marketing Category : BULK INGREDIENT

      Nuray Chemicals

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      02

      Zhejiang Kingland Pharmaceutical Co...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Kingland Pharmaceutical Co...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 84824-003

      Start Marketing Date : 2024-10-14

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      03

      Zhejiang Kingland Pharmaceutical Co...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Kingland Pharmaceutical Co...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 84824-003

      Start Marketing Date : 2024-10-14

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      04

      Zhejiang Kingland Pharmaceutical Co...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Kingland Pharmaceutical Co...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 84824-003

      Start Marketing Date : 2024-10-14

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      05

      Zhejiang Kingland Pharmaceutical Co...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Kingland Pharmaceutical Co...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 84824-003

      Start Marketing Date : 2024-10-14

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      06

      Medisca Inc.

      U.S.A
      PharmaLytica
      Not Confirmed
      arrow

      Medisca Inc.

      U.S.A
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag U.S.A
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 38779-3318

      Start Marketing Date : 2024-12-06

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1g/g)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      07

      QINGDAO TIDA BIOTEK CO.,LTD

      China
      PharmaLytica
      Not Confirmed
      arrow

      QINGDAO TIDA BIOTEK CO.,LTD

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 90027-019

      Start Marketing Date : 2022-09-20

      End Marketing Date : 2027-05-28

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT FOR HUMAN P...

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      08

      DSM Nutritional Products Ltd.

      Netherlands
      PharmaLytica
      Not Confirmed
      arrow

      DSM Nutritional Products Ltd.

      Netherlands
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag Netherlands
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 63238-3150

      Start Marketing Date : 2022-12-28

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      09

      DSM Nutritional Products LLC

      Netherlands
      PharmaLytica
      Not Confirmed
      arrow

      DSM Nutritional Products LLC

      Netherlands
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag Netherlands
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 63238-3150

      Start Marketing Date : 2017-12-20

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      10

      Zhejiang Shengda Bio-Pharm Co., Ltd...

      China
      PharmaLytica
      Not Confirmed
      arrow

      Zhejiang Shengda Bio-Pharm Co., Ltd...

      China
      arrow
      PharmaLytica
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
      Post an Enquiry Post an Enquiry
      Flag China
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      BIOTIN

      NDC Package Code : 67421-002

      Start Marketing Date : 2024-08-20

      End Marketing Date : 2025-12-31

      Dosage Form (Strength) : POWDER (1kg/kg)

      Marketing Category : BULK INGREDIENT

      blank

      Portfolio PDF

      Product Web Link

      Virtual Booth

      Digital Content

      Website

      Corporate PDF

      Only 10 entries up to this point, click to access all click full view read-more
      click full view
      Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

      DRUG PRODUCT COMPOSITIONS

      Do you need Business Intel? Ask us

      DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

      USFDA APPLICATION NUMBER - 18920

      read-more

      DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

      USFDA APPLICATION NUMBER - 21163

      read-more

      DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

      USFDA APPLICATION NUMBER - 21163

      read-more

      DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

      USFDA APPLICATION NUMBER - 21625

      read-more

      DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

      USFDA APPLICATION NUMBER - 8809

      read-more

      Related Excipient Companies

      Upload your portfolio for free, ask us

      Excipients by Applications

      Click here to find the perfect excipient manufacturers by their capabilities

      Fillers, Diluents & Binders

      read-more
      read-more

      Topical

      read-more
      read-more

      Coating Systems & Additives

      read-more
      read-more

      Thickeners and Stabilizers

      read-more
      read-more

      Solubilizers

      read-more
      read-more

      Parenteral

      read-more
      read-more

      Direct Compression

      read-more
      read-more

      Controlled & Modified Release

      read-more
      read-more

      Disintegrants & Superdisintegrants

      read-more
      read-more

      Taste Masking

      read-more
      read-more

      Granulation

      read-more
      read-more

      Film Formers & Plasticizers

      read-more
      read-more

      Lubricants & Glidants

      read-more
      read-more

      Chewable & Orodispersible Aids

      read-more
      read-more

      Emulsifying Agents

      read-more
      read-more

      Co-Processed Excipients

      read-more
      read-more

      Rheology Modifiers

      read-more
      read-more

      Surfactant & Foaming Agents

      read-more
      read-more

      Empty Capsules

      read-more
      read-more

      API Stability Enhancers

      read-more
      read-more

      Coloring Agents

      read-more
      read-more

      Vegetarian Capsules

      read-more
      read-more

      Soft Gelatin

      read-more
      read-more

      Digital Content read-more

      Create Content with PharmaCompass, ask us

      DATA COMPILATION #PharmaFlow

      read-more
      read-more

      NEWS #PharmaBuzz

      read-more
      read-more

      Global Sales Information

      Do you need Business Intel? Ask us

      Market Place

      Do you need sourcing support? Ask us

      REF. STANDARDS & IMPURITIES

      Upload your portfolio for free, ask us

      USP

      read-more
      read-more

      ABOUT THIS PAGE

      Looking for 58-85-5 / Biotin API manufacturers, exporters & distributors?

      Biotin manufacturers, exporters & distributors 1

      92

      PharmaCompass offers a list of Biotin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Biotin manufacturer or Biotin supplier for your needs.

      Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Biotin manufacturer or Biotin supplier.

      PharmaCompass also assists you with knowing the Biotin API Price utilized in the formulation of products. Biotin API Price is not always fixed or binding as the Biotin Price is obtained through a variety of data sources. The Biotin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

      API | Excipient name

      Biotin

      Synonyms

      D-biotin, 58-85-5, Vitamin h, Vitamin b7, Coenzyme r, Bioepiderm

      Cas Number

      58-85-5

      Unique Ingredient Identifier (UNII)

      6SO6U10H04

      About Biotin

      A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.

      Biotin Manufacturers

      A Biotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biotin, including repackagers and relabelers. The FDA regulates Biotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biotin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

      click here to find a list of Biotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

      Biotin Suppliers

      A Biotin supplier is an individual or a company that provides Biotin active pharmaceutical ingredient (API) or Biotin finished formulations upon request. The Biotin suppliers may include Biotin API manufacturers, exporters, distributors and traders.

      click here to find a list of Biotin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

      Biotin USDMF

      A Biotin DMF (Drug Master File) is a document detailing the whole manufacturing process of Biotin active pharmaceutical ingredient (API) in detail. Different forms of Biotin DMFs exist exist since differing nations have different regulations, such as Biotin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

      A Biotin DMF submitted to regulatory agencies in the US is known as a USDMF. Biotin USDMF includes data on Biotin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biotin USDMF is kept confidential to protect the manufacturer’s intellectual property.

      click here to find a list of Biotin suppliers with USDMF on PharmaCompass.

      Biotin JDMF

      The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

      The Biotin Drug Master File in Japan (Biotin JDMF) empowers Biotin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

      PMDA reviews the Biotin JDMF during the approval evaluation for pharmaceutical products. At the time of Biotin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

      click here to find a list of Biotin suppliers with JDMF on PharmaCompass.

      Biotin KDMF

      In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

      Pharmaceutical companies submit a Biotin Drug Master File in Korea (Biotin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Biotin. The MFDS reviews the Biotin KDMF as part of the drug registration process and uses the information provided in the Biotin KDMF to evaluate the safety and efficacy of the drug.

      After submitting a Biotin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Biotin API can apply through the Korea Drug Master File (KDMF).

      click here to find a list of Biotin suppliers with KDMF on PharmaCompass.

      Biotin CEP

      A Biotin CEP of the European Pharmacopoeia monograph is often referred to as a Biotin Certificate of Suitability (COS). The purpose of a Biotin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Biotin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Biotin to their clients by showing that a Biotin CEP has been issued for it. The manufacturer submits a Biotin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Biotin CEP holder for the record. Additionally, the data presented in the Biotin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Biotin DMF.

      A Biotin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Biotin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

      click here to find a list of Biotin suppliers with CEP (COS) on PharmaCompass.

      Biotin NDC

      National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Biotin as an active pharmaceutical ingredient (API).

      Finished drug products

      The FDA updates the NDC directory daily. The NDC numbers for Biotin API and other APIs are published in this directory by the FDA.

      Unfinished drugs

      The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

      Pharmaceutical companies that manufacture Biotin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

      Compounded drug products

      The NDC directory also contains data on finished compounded human drug products that contain Biotin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Biotin NDC to their finished compounded human drug products, they may choose to do so.

      click here to find a list of Biotin suppliers with NDC on PharmaCompass.

      Biotin GMP

      Biotin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

      GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

      PharmaCompass offers a list of Biotin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Biotin GMP manufacturer or Biotin GMP API supplier for your needs.

      Biotin CoA

      A Biotin CoA (Certificate of Analysis) is a formal document that attests to Biotin's compliance with Biotin specifications and serves as a tool for batch-level quality control.

      Biotin CoA mostly includes findings from lab analyses of a specific batch. For each Biotin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

      Biotin may be tested according to a variety of international standards, such as European Pharmacopoeia (Biotin EP), Biotin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Biotin USP).

      Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
      For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
      Ask Us for Pharmaceutical Supplier and Partner
      Ask Us, Find A Supplier / Partner
      No Commissions, No Strings Attached, Get Connected for FREE

      What are you looking for?

      How can we help you?

      The request can't be empty

      Please read our Privacy Policy carefully

      You must agree to the privacy policy

      The name can't be empty
      The company can't be empty.
      The email can't be empty Please enter a valid email.
      The mobile can't be empty

      Market Place

      Market Place

      PharmaCompass

      Home

      Market Place

      Menu

      Post Enquiry

      Post Enquiry

      Market Place

      Market Place

      Search
      OSZAR »