Aspen API. More than just an API.
01 1Aspen API
02 1Symbiotec Pharmalab
03 1Pfizer CentreOne
04 2Bayer AG
05 1Hubei Zhuxi Humanwell Pharmaceutical
06 1Steroid SpA
07 1Zhejiang Xianju Pharmaceutical Co. Ltd
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-26
Pay. Date : 2015-09-24
DMF Number : 14540
Submission : 1999-11-18
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-10-03
DMF Number : 25534
Submission : 2011-11-28
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2016-05-02
DMF Number : 24500
Submission : 2011-03-01
Status :
Type : II
A Testosterone Undecanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone Undecanoate, including repackagers and relabelers. The FDA regulates Testosterone Undecanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone Undecanoate 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 Undecanoate supplier is an individual or a company that provides Testosterone Undecanoate active pharmaceutical ingredient (API) or Testosterone Undecanoate finished formulations upon request. The Testosterone Undecanoate suppliers may include Testosterone Undecanoate API manufacturers, exporters, distributors and traders.
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A Testosterone Undecanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Testosterone Undecanoate active pharmaceutical ingredient (API) in detail. Different forms of Testosterone Undecanoate DMFs exist exist since differing nations have different regulations, such as Testosterone Undecanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testosterone Undecanoate DMF submitted to regulatory agencies in the US is known as a USDMF. Testosterone Undecanoate USDMF includes data on Testosterone Undecanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testosterone Undecanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testosterone Undecanoate suppliers with USDMF on PharmaCompass.
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