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List of Drug Master Files (DMF) of AM20060748 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 11,776Xls
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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Dr. Reddy\'s Laboratories

03 1Medichem S.A

04 1Neuland Laboratories

05 1Cipla

06 1GLAND PHARMA LIMITED

07 1MSN Laboratories

08 1Quimica Sintetica

09 1Solara Active Pharma Sciences

10 1YUNG ZIP CHEMICAL INDUSTRIAL

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2024-02-27

Pay. Date : 2024-01-22

DMF Number : 34751

Submission : 2020-06-16

Status : Active

Type : II

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-01

Pay. Date : 2020-09-21

DMF Number : 34449

Submission : 2019-12-31

Status : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-04

Pay. Date : 2020-10-15

DMF Number : 35211

Submission : 2020-10-26

Status : Active

Type : II

Medichem

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-16

Pay. Date : 2020-10-23

DMF Number : 35204

Submission : 2020-09-29

Status : Active

Type : II

Neuland

05

Formnext Forum
Not Confirmed

05

06

Formnext Forum
Not Confirmed

08

Formnext Forum
Not Confirmed

08

Formnext Forum
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2020-07-20

Pay. Date : 2020-06-05

DMF Number : 34776

Submission : 2020-05-12

Status : Active

Type : II

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AM20060748 Manufacturers | Traders | Suppliers

AM20060748 Manufacturers, Traders, Suppliers 1