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List of Drug Master Files (DMF) of TXD258 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 361,376Xls
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01 1Sanofi

02 1Dr. Reddy\'s Laboratories

03 1Sichuan Elixir Pharmaceuticals

04 1Hetero Drugs

05 1Indena

06 1Intas Pharmaceuticals

07 1Laurus Labs

08 1Lunan Pharmaceutical

09 2MSN Laboratories

10 2Polymed Therapeutics Inc.

11 1Qilu Pharmaceutical

12 1Shilpa Medicare

13 1Sichuan Xieli Pharmaceutical

14 1Teva API

15 1Tianjin Weijie Pharmaceutical Co., Ltd.

16 1Yung Shin Pharmaceutical Industrial

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23496

Submission : 2010-01-29

Status : Active

Type : II

Sanofi Company Banner

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 : 2014-06-17

Pay. Date : 2014-03-20

DMF Number : 27895

Submission : 2014-02-18

Status : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39645

Submission : 2024-03-26

Status : Active

Type : II

Sichuan Elixir Pharmaceuticals

04

FNCE 2024
Not Confirmed

05

FNCE 2024
Not Confirmed

06

FNCE 2024
Not Confirmed

09

FNCE 2024
Not Confirmed