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List of Drug Master Files (DMF) of AM20060780 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 63Xls
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01 1Granules India Limited

02 1Aarti Pharmalabs

03 1Supriya Lifescience

04 1Alembic Pharmaceuticals Limited

05 1Aurobindo Pharma Limited

06 1Cadila Pharmaceuticals

07 1Chemeca Drugs

08 2Chemi SpA

09 1Cilag AG

10 1Derivados Quimicos SAU

11 1Dipharma

12 1Divis Laboratories

13 1Emnar Pharma

14 1Erregierre SpA

15 1Glenmark Life Sciences

16 1HANZHONG HANJIANG VENTUREPHARM PHARMACEUTICAL LTD

17 2Hetero Drugs

18 2Hikal

19 1Ipca Laboratories

20 1Jubilant Generics

21 1Lupin Ltd

22 1NORDIC SYNTHESIS AB

23 1Olon S.p.A

24 1Seven Star Pharmaceutical

25 1Sifavitor srl

26 1Solmag

27 1Sun Pharmaceutical Industries Limited

28 1UQUIFA

29 1ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD.

30 1Zhejiang Apeloa Jiayuan Pharmaceutical

31 1Zhejiang Shaxing Pharm. & Chem

32 2Zhejiang Supor Pharmaceuticals Co., LTD

33 2Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2021-05-27

Pay. Date : 2021-04-15

DMF Number : 35694

Submission : 2021-03-29

Status : Active

Type : II

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-19

Pay. Date : 2013-06-25

DMF Number : 27204

Submission : 2013-06-17

Status : Active

Type : II

Aarti Industries Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33538

Submission : 2019-01-25

Status : Active

Type : II

Supriya

06

AAPS 2024
Not Confirmed

08

AAPS 2024
Not Confirmed

10

AAPS 2024
Not Confirmed