01 1Pfizer Inc
01 1MENOGAROL (U-52,047,Nsc-269148)PRODUCED KALAMAZOO, MICHIGAN FACILITIES
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5040
Submission : 1983-07-15
Status : Inactive
Type : II
A Menogarol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Menogarol, including repackagers and relabelers. The FDA regulates Menogarol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Menogarol 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 Menogarol supplier is an individual or a company that provides Menogarol active pharmaceutical ingredient (API) or Menogarol finished formulations upon request. The Menogarol suppliers may include Menogarol API manufacturers, exporters, distributors and traders.
click here to find a list of Menogarol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Menogarol DMF (Drug Master File) is a document detailing the whole manufacturing process of Menogarol active pharmaceutical ingredient (API) in detail. Different forms of Menogarol DMFs exist exist since differing nations have different regulations, such as Menogarol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Menogarol DMF submitted to regulatory agencies in the US is known as a USDMF. Menogarol USDMF includes data on Menogarol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Menogarol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Menogarol suppliers with USDMF on PharmaCompass.
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