01 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1TESTOSTERONE TRIDECANOATE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37890
Submission : 2023-02-06
Status : Active
Type : II
A Testosterone Decanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone Decanoate, including repackagers and relabelers. The FDA regulates Testosterone Decanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone Decanoate 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 Testosterone Decanoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Testosterone Decanoate supplier is an individual or a company that provides Testosterone Decanoate active pharmaceutical ingredient (API) or Testosterone Decanoate finished formulations upon request. The Testosterone Decanoate suppliers may include Testosterone Decanoate API manufacturers, exporters, distributors and traders.
click here to find a list of Testosterone Decanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Testosterone Decanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Testosterone Decanoate active pharmaceutical ingredient (API) in detail. Different forms of Testosterone Decanoate DMFs exist exist since differing nations have different regulations, such as Testosterone Decanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testosterone Decanoate DMF submitted to regulatory agencies in the US is known as a USDMF. Testosterone Decanoate USDMF includes data on Testosterone Decanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testosterone Decanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testosterone Decanoate suppliers with USDMF on PharmaCompass.
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