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

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$ API Ref.Price (USD/KG) : 13Xls
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01 2Granules India Limited

02 1Sanofi

03 1Synthokem Labs

04 1Chunghwa Chemical Synthesis & Biotech

05 2Boehringer Ingelheim GmbH

06 1CHEMSPEC CHEMICALS PVT LTD

07 1CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORP

08 1Delta Synthetic Co. Ltd

09 1Ningbo Smart Pharmaceutical

10 2PAN DRUGS LTD

11 1Seven Star Pharmaceutical

12 1Zhejiang Haizhou Jianfeng

13 1Zhejiang Jianfeng Haizhou

14 2Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-19

Pay. Date : 2014-03-11

DMF Number : 14372

Submission : 1999-08-30

Status : Active

Type : II

Granules India

02

  • 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 : 4989

Submission : 1983-06-28

Status : Inactive

Type : II

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSynthokem Labs specializes in producing APIs and intermediates for the global pharma industry.

GDUFA

DMF Review : Complete

Rev. Date : 2014-04-08

Pay. Date : 2013-09-12

DMF Number : 10413

Submission : 1993-08-13

Status : Active

Type : II

Synthokem Labs

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : Complete

Rev. Date : 2016-05-24

Pay. Date : 2016-03-24

DMF Number : 14234

Submission : 1999-06-24

Status : Active

Type : II

CCSB Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20998

Submission : 2007-10-31

Status : Active

Type : II

Granules India

07

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Not Confirmed

07

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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-14

Pay. Date : 2013-11-29

DMF Number : 5809

Submission : 1985-04-11

Status : Active

Type : II

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10

Peboc Ltd

Country

USDMF

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Not Confirmed

10

Peboc Ltd

Country
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Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4866

Submission : 1983-03-08

Status : Inactive

Type : II

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