Ami Lifesciences Private Limited DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

17 Mar 2025

// PRESS RELEASE

Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

17 Mar 2025

// PRESS RELEASE

Ami is redefining API excellence through precision manufacturing

17 Mar 2025

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

Contact Supplier

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CPhI China

Booth #E1F57

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envelop Contact Supplier

DIGITAL CONTENT

3 Corporate Content #SupplierSpotlight, 1 Data Compilation #PharmaFlow, 28 News #PharmaBuzz

media
3 Corporate Content #SupplierSpotlight
1 Data Compilation #PharmaFlow
28 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

98 All APIs, 33 USDMF, 13 CEP/COS, 2 JDMF, 32 EU WC, 62 KDMF, 5 NDC API, 60 Listed APIs

98 All APIs
33 USDMF
13 CEP/COS
2 JDMF
32 EU WC
62 KDMF
5 NDC API
60 Listed APIs

KEY PRODUCTS

Deucravacitinib, Resmetirom, Salcaprozate Sodium, Vibegron

Deucravacitinib
Resmetirom
Salcaprozate Sodium
Vibegron

SERVICES

API Manufacturing, API & Drug Product Development

pharmaServices
API Manufacturing
API & Drug Product Development
- 4 API Development

EXCIPIENTS

1 All Excipients, 1 USDMF

excipientPortfolio
1 All Excipients
1 USDMF

INSPECTIONS & REGISTRATIONS

2 EDQM, 2 WHO-GMP

inspections
2 EDQM
2 WHO-GMP

AMI Lifesciences is Driven by Chemistry. Powered by People.

About

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

CPhI ChinaCPhI China

Industry Trade Show

Booth #E1F57

24-26 June, 2025

SNIEC, Shanghai, China
APS SymposiumAPS Symposium

Industry Trade Show

Not Confirmed

15-19 June, 2025

San Diego
DIA 2025DIA 2025

Industry Trade Show

Not Confirmed

15-19 June, 2025

San Diego

CONTACT DETAILS

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Country

India

Address

701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodar...

Telephone

+91 2652323046

[email protected]

Website

http://amilifesciences.com/

https://www.linkedin.com/company/amilifesciences/

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CORPORATE CONTENT #SupplierSpotlight

Product List 2025

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Corporate Presentation

GMP Certificate 2019

DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 7677

NEWS #PharmaBuzz

Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

17 Mar 2025

// PRESS RELEASE

Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

17 Mar 2025

// PRESS RELEASE

Ami is redefining API excellence through precision manufacturing

17 Mar 2025

// PRESS RELEASE

Ami Lifesciences Submits US DMF for Tegoprazan

08 Oct 2024

// PRESS RELEASE

Ami Lifesciences Gets CADIFA Approval for Vonoprazan

02 Aug 2024

// PRESS RELEASE

Oxcarbazepine Receives CEP Approval from EDQM

02 Aug 2024

// PRESS RELEASE

ALL APIs

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USDMF

01

Bempedoic Acid

India

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GDUFA

DMF Review : N/A

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DMF Number : 37511

Submission : 2022-10-03

Status : Active

Type : II

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02

Benzonatate

India

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GDUFA

DMF Review : N/A

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DMF Number : 39002

Submission : 2023-12-04

Status : Active

Type : II

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03

Brivaracetam

India

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DMF Number : 36655

Submission : 2022-01-08

Status : Active

Type : II

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04

Dapagliflozin Amorphous

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DMF Number : 38009

Submission : 2023-02-23

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Type : II

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05

Dapagliflozin Propanediol Monohydrat...

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DMF Number : 38010

Submission : 2023-02-23

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Type : II

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06

Daprodustat

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DMF Number : 38516

Submission : 2023-06-30

Status : Active

Type : II

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07

Desvenlafaxine Succinate

India

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DMF Number : 38066

Submission : 2023-03-03

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Type : II

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08

Diacerein

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DMF Number : 38766

Submission : 2023-09-15

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Type : II

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09

Dicyclomine Hydrochloride

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DMF Number : 40078

Submission : 2024-09-21

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Type : II

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10

Edoxaban Tosylate Monohydrate

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DMF Number : 38201

Submission : 2023-03-24

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Type : II

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CEP/COS

01

Ambroxol hydrochloride

India

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Certificate Numbers : CEP 2014-135 - Rev 03

Status : Valid

Issue Date : 2024-03-25

Type : Chemical

Substance Number : 1489

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Ambroxol hydrochloride, Process II

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Certificate Numbers : CEP 2023-168 - Rev 01

Status : Valid

Issue Date : 2025-04-28

Type : Chemical

Substance Number : 1489

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03

Betahistine dihydrochloride

India

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Certificate Numbers : CEP 2011-101 - Rev 04

Status : Valid

Issue Date : 2024-07-31

Type : Chemical

Substance Number : 1665

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Diacerein

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Certificate Numbers : CEP 2015-173 - Rev 03

Status : Valid

Issue Date : 2024-12-03

Type : Chemical

Substance Number : 2409

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Gliclazide

India

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Certificate Numbers : CEP 2021-465 - Rev 00

Status : Valid

Issue Date : 2024-02-15

Type : Chemical

Substance Number : 1524

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Oxcarbazepine

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Certificate Numbers : CEP 2022-108 - Rev 02

Status : Valid

Issue Date : 2025-01-30

Type : Chemical

Substance Number : 2577

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Rivaroxaban

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Certificate Numbers : CEP 2022-215 - Rev 01

Status : Valid

Issue Date : 2025-03-12

Type : Chemical

Substance Number : 2932

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Sitagliptin phosphate monohydrate

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Certificate Numbers : CEP 2022-340 - Rev 00

Status : Valid

Issue Date : 2024-05-06

Type : Chemical

Substance Number : 2778

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Sitagliptin phosphate monohydrate, Proce...

India

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Certificate Numbers : CEP 2024-249 - Rev 00

Status : Valid

Issue Date : 2024-12-19

Type : Chemical

Substance Number : 2778

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Tadalafil

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Certificate Numbers : CEP 2014-339 - Rev 03

Status : Valid

Issue Date : 2024-02-14

Type : Chemical

Substance Number : 2606

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JDMF

01

Ambroxol Hydrochloride

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Ami Lifesciences Private Limited

Registration Number : 305MF10118

Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

Initial Date of Registration : 2023-11-01

Latest Date of Registration : 2023-11-01

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Vildagliptin

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Date of Issue : 2022-08-18

Valid Till : 2025-06-26

Written Confirmation Number : WC-0054

Address of the Firm : Block No. 82/B, ECP Road, At &...

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KDMF

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NDC API

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LISTED APIs

01

Acebrophylline

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KEY PRODUCTS

Services

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API Manufacturing

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Scale Up

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Small Molecules

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High Potency APIs (HPAPIs)

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Custom Synthesis & Manufacturing

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API & Drug Product Development

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API Development

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Excipients

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USDMF

01

SALCAPROZATE SODIUM

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DMF Review : N/A

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DMF Number : 40707

Submission : 2024-11-26

Status : Active

Type : IV

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EDQM

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WHO-GMP

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ABOUT THIS PAGE

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Ami Lifesciences Private Limited is a supplier offers 74 products (APIs, Excipients or Intermediates).

Find a price of Ambroxol Hydrochloride bulk with CEP, JDMF, WC offered by Ami Lifesciences Private Limited

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EVENTS

Webinars & Exhibitions

DIGITAL CONTENT

3 Corporate Content #SupplierSpotlight

1 Data Compilation #PharmaFlow

28 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

98 All APIs

33 USDMF

13 CEP/COS

2 JDMF

32 EU WC

62 KDMF

5 NDC API

60 Listed APIs

KEY PRODUCTS

SERVICES

API Manufacturing

API & Drug Product Development

EXCIPIENTS

1 All Excipients

1 USDMF

INSPECTIONS & REGISTRATIONS

2 EDQM

2 WHO-GMP

01

02

03

04

05

06

07

08

09

10

Valid

CEP 2014-135 - Rev 03

Chemical

2024-03-25

1489

01

Valid

CEP 2023-168 - Rev 01

Chemical

2025-04-28

1489

02

Valid

CEP 2011-101 - Rev 04

Chemical

2024-07-31

1665

03

Valid

CEP 2015-173 - Rev 03

Chemical

2024-12-03

2409

04

Valid

CEP 2021-465 - Rev 00

Chemical

2024-02-15

1524

05

Valid

CEP 2022-108 - Rev 02

Chemical

2025-01-30

2577

06

Valid

CEP 2022-215 - Rev 01

Chemical

2025-03-12