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

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$ API Ref.Price (USD/KG) : 77Xls
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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Evonik

03 1Metrochem API Private Limited

04 1Nuray Chemicals Private Limited

05 3Ajinomoto Company

06 1BD BIOSCIENCES ADVANCED BIOPROCESSING

07 1Emmaus Life Sciences

08 2Irvine Scientific Sales Company

09 1Katayama Seiyakusyo

10 1Kyowa Hakko Bio

11 1Mitsubishi Tanabe Pharma

12 26SAFC

13 1Blank

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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 : N/A

Rev. Date :

Pay. Date :

DMF Number : 37695

Submission : 2022-12-01

Status : Active

Type : II

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9486

Submission : 1992-01-03

Status : Active

Type : II

Evonik company banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38992

Submission : 2023-12-28

Status : Active

Type : II

Metrochem

04

  • 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.

GDUFA

DMF Review : Complete

Rev. Date : 2021-10-22

Pay. Date : 2021-08-25

DMF Number : 36082

Submission : 2021-08-26

Status : Active

Type : II

Nuray Chemicals

06

Discovery on Target
Not Confirmed

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