Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Sanofi
03 1Aspen API
04 13M Drug Delivery Systems
05 1Bayer AG
06 1Cygnus Inc
07 3Gedeon Richter
08 1Industriale Chimica
09 1Lupin Ltd
10 1Merck & Co
11 1Pfizer Inc
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-24
DMF Number : 26020
Submission : 2012-05-02
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 : 2425
Submission : 1975-03-27
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-04
Pay. Date : 2012-11-14
DMF Number : 3803
Submission : 1980-05-20
Status :
Type : II
A Ethinylestriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethinylestriol, including repackagers and relabelers. The FDA regulates Ethinylestriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethinylestriol 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 Ethinylestriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethinylestriol supplier is an individual or a company that provides Ethinylestriol active pharmaceutical ingredient (API) or Ethinylestriol finished formulations upon request. The Ethinylestriol suppliers may include Ethinylestriol API manufacturers, exporters, distributors and traders.
click here to find a list of Ethinylestriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethinylestriol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethinylestriol active pharmaceutical ingredient (API) in detail. Different forms of Ethinylestriol DMFs exist exist since differing nations have different regulations, such as Ethinylestriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethinylestriol DMF submitted to regulatory agencies in the US is known as a USDMF. Ethinylestriol USDMF includes data on Ethinylestriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethinylestriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethinylestriol suppliers with USDMF on PharmaCompass.
We have 11 companies offering Ethinylestriol
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