Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 2Sanofi
02 1Aspen API
03 2Bayer AG
04 1Fareva
05 2Gedeon Richter
06 1Lupin Ltd
07 1Merck & Co
08 1Mitsubishi Corporation
09 1Naari
10 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
11 2Blank
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 : 1920
Submission : 1972-04-17
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-20
DMF Number : 3849
Submission : 1980-05-22
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 : 8239
Submission : 1989-10-05
Status :
Type : II
A Loestrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loestrin, including repackagers and relabelers. The FDA regulates Loestrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loestrin 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 Loestrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loestrin supplier is an individual or a company that provides Loestrin active pharmaceutical ingredient (API) or Loestrin finished formulations upon request. The Loestrin suppliers may include Loestrin API manufacturers, exporters, distributors and traders.
click here to find a list of Loestrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loestrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Loestrin active pharmaceutical ingredient (API) in detail. Different forms of Loestrin DMFs exist exist since differing nations have different regulations, such as Loestrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loestrin DMF submitted to regulatory agencies in the US is known as a USDMF. Loestrin USDMF includes data on Loestrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loestrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loestrin suppliers with USDMF on PharmaCompass.
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