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

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01 3Chirogate International

02 1Nuray Chemicals Private Limited

03 1EUROAPI

04 1Dr. Reddy\'s Laboratories

05 1Alphora Research

06 1Changzhou BOHIV Pharmaceutical

07 1DMFs Not Supported

08 1Emcure Pharmaceuticals

09 2MSN Laboratories

10 1Mannkind

11 1Pfizer Inc

12 1Yonsung Fine Chemicals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChirogate is a professional Prostaglandin manufacturer.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28340

Submission : 2016-08-15

Status : Active

Type : II

Chirogate CB

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 : 2017-02-16

Pay. Date : 2016-09-20

DMF Number : 30861

Submission : 2016-09-27

Status : Active

Type : II

Nuray Chemicals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-23

Pay. Date : 2016-11-25

DMF Number : 31145

Submission : 2016-12-09

Status : Active

Type : II

EUROAPI Compnay Banner

04

  • 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 : 2016-07-06

Pay. Date : 2016-06-10

DMF Number : 30106

Submission : 2016-01-12

Status : Active

Type : II

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChirogate is a professional Prostaglandin manufacturer.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 29207

Submission : 2015-08-12

Status : Active

Type : II

Chirogate CB

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChirogate is a professional Prostaglandin manufacturer.

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-06

Pay. Date : 2014-07-15

DMF Number : 28458

Submission : 2014-09-16

Status : Active

Type : II

Chirogate CB

10

FNCE 2024
Not Confirmed

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