Aspen API. More than just an API.
01 1Aspen API
02 1Symbiotec Pharmalab
03 1Sanofi
04 1Bayer AG
05 1Biovet AD
06 1Pfizer Inc
07 1Steroid SpA
08 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3877
Submission : 1980-06-25
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-26
Pay. Date : 2018-04-17
DMF Number : 26166
Submission : 2012-06-19
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 : 3781
Submission : 1980-04-15
Status :
Type : II
A Testosterone Enanthate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone Enanthate, including repackagers and relabelers. The FDA regulates Testosterone Enanthate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone Enanthate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Testosterone Enanthate DMF (Drug Master File) is a document detailing the whole manufacturing process of Testosterone Enanthate active pharmaceutical ingredient (API) in detail. Different forms of Testosterone Enanthate DMFs exist exist since differing nations have different regulations, such as Testosterone Enanthate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testosterone Enanthate DMF submitted to regulatory agencies in the US is known as a USDMF. Testosterone Enanthate USDMF includes data on Testosterone Enanthate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testosterone Enanthate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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