Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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
Granules 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 :
Type : II
Sanofi 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 :
Type : II
Synthokem 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 :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14234
Submission : 1999-06-24
Status :
Type : II
Granules 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 :
Type : II
A Oresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oresol, including repackagers and relabelers. The FDA regulates Oresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oresol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Oresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oresol supplier is an individual or a company that provides Oresol active pharmaceutical ingredient (API) or Oresol finished formulations upon request. The Oresol suppliers may include Oresol API manufacturers, exporters, distributors and traders.
click here to find a list of Oresol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oresol DMF (Drug Master File) is a document detailing the whole manufacturing process of Oresol active pharmaceutical ingredient (API) in detail. Different forms of Oresol DMFs exist exist since differing nations have different regulations, such as Oresol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oresol DMF submitted to regulatory agencies in the US is known as a USDMF. Oresol USDMF includes data on Oresol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oresol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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