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

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$ API Ref.Price (USD/KG) : 84,223Xls
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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Nuray Chemicals Private Limited

03 1Dipharma SA

04 1Saurav Chemicals

05 1Teva API

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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 : 2020-08-28

Pay. Date : 2020-08-06

DMF Number : 33948

Submission : 2019-07-17

Status : Active

Type : II

Biophore

02

  • 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 : 2017-02-01

Pay. Date : 2016-12-26

DMF Number : 31250

Submission : 2017-01-02

Status : Active

Type : II

Nuray Chemicals

03

Discovery on Target
Not Confirmed

03

Discovery on Target
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2021-09-21

Pay. Date : 2021-08-02

DMF Number : 36026

Submission : 2021-07-31

Status : Active

Type : II

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04

Discovery on Target
Not Confirmed

05

Discovery on Target
Not Confirmed

Nitisinone Manufacturers | Traders | Suppliers

Nitisinone Manufacturers, Traders, Suppliers 1
98

We have 5 companies offering Nitisinone

Get in contact with the supplier of your choice:

  1. Biophore India Pharmaceuticals Pvt Ltd
  2. Nuray Chemicals Private Limited
  3. Dipharma SA
  4. Saurav Chemicals
  5. Teva API