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List of Drug Master Files (DMF) of Sitagliptin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 666Xls
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01 1Wavelength Pharmaceuticals

02 1IOL Chemicals and Pharmaceuticals

03 2Moehs Iberica

04 2Ami Lifesciences Private Limited

05 1Actis Generics Pvt Ltd

06 1Almelo

07 1Amoli Organics

08 1Apotex Pharmachem

09 1Aurobindo Pharma Limited

10 1Beijing Huikang Boyuan Chemical Tech CO.

11 3Biocon

12 2Fuxin Long Rui Pharmaceutical

13 3Glenmark Life Sciences

14 1HEC Pharm

15 2HONOUR LAB LTD

16 2Hikal

17 1Jubilant Generics

18 1Laurus Labs

19 2Lee Pharma

20 1Lunan Pharmaceutical

21 1Lupin Ltd

22 5MSN Laboratories

23 1Macleods Pharmaceuticals Limited

24 1Mankind Pharma

25 2Morepen Laboratories

26 1Optimus Pharma

27 1SINTENOVO, S.A. DE C.V.

28 1Sichuan Xieli Pharmaceutical

29 1Signa S.A. de C.V.

30 1Sun Pharmaceutical Industries Limited

31 3Teva API

32 1Torrent Pharmaceuticals Limited

33 1UQUIFA

34 1Viatris

35 2Viwit Pharmaceuticals Limited

36 1Wockhardt

37 2Zhejiang Apeloa Jiayuan Pharmaceutical

38 1Zhejiang Changming Pharmaceuticals

39 1Zhejiang Huahai Pharmaceutical

40 1Zhejiang Jingsheng Pharmaceutical

41 1Zhejiang Jiuzhou Pharmaceutical

42 2Zhejiang Yongtai Technology

43 2Zydus Lifesciences

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PharmaCompass

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38931

Submission : 2024-01-31

Status : Active

Type : II

IOL Chemicals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

GDUFA

DMF Review : Complete

Rev. Date : 2019-02-15

Pay. Date : 2018-09-20

DMF Number : 33206

Submission : 2018-09-28

Status : Active

Type : II

Moehs Iberica

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37030

Submission : 2022-05-02

Status : Active

Type : II

AMI Lifesciences

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

GDUFA

DMF Review : Complete

Rev. Date : 2024-02-27

Pay. Date : 2023-10-11

DMF Number : 38921

Submission : 2023-09-28

Status : Active

Type : II

Moehs Iberica

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39354

Submission : 2024-01-20

Status : Active

Type : II

AMI Lifesciences

08

Boulder Peptide 2024
Not Confirmed

10

Boulder Peptide 2024
Not Confirmed