01 1Pfizer Inc
01 1TESTOLACTONE, USP
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3053
Submission : 1977-11-17
Status : Inactive
Type : II
A Testolactone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testolactone, including repackagers and relabelers. The FDA regulates Testolactone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testolactone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Testolactone supplier is an individual or a company that provides Testolactone active pharmaceutical ingredient (API) or Testolactone finished formulations upon request. The Testolactone suppliers may include Testolactone API manufacturers, exporters, distributors and traders.
click here to find a list of Testolactone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Testolactone DMF (Drug Master File) is a document detailing the whole manufacturing process of Testolactone active pharmaceutical ingredient (API) in detail. Different forms of Testolactone DMFs exist exist since differing nations have different regulations, such as Testolactone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testolactone DMF submitted to regulatory agencies in the US is known as a USDMF. Testolactone USDMF includes data on Testolactone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testolactone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testolactone suppliers with USDMF on PharmaCompass.
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