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