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
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A Teslac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teslac, including repackagers and relabelers. The FDA regulates Teslac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teslac 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 Teslac supplier is an individual or a company that provides Teslac active pharmaceutical ingredient (API) or Teslac finished formulations upon request. The Teslac suppliers may include Teslac API manufacturers, exporters, distributors and traders.
click here to find a list of Teslac suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Teslac DMF (Drug Master File) is a document detailing the whole manufacturing process of Teslac active pharmaceutical ingredient (API) in detail. Different forms of Teslac DMFs exist exist since differing nations have different regulations, such as Teslac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teslac DMF submitted to regulatory agencies in the US is known as a USDMF. Teslac USDMF includes data on Teslac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teslac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teslac suppliers with USDMF on PharmaCompass.
