01 1Pfizer Inc
01 1ESTRAMUSTINE PHOSPHATE SODIUM
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6258
Submission : 1986-03-27
Status : Active
Type : II
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A Estramustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estramustine, including repackagers and relabelers. The FDA regulates Estramustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estramustine 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 Estramustine supplier is an individual or a company that provides Estramustine active pharmaceutical ingredient (API) or Estramustine finished formulations upon request. The Estramustine suppliers may include Estramustine API manufacturers, exporters, distributors and traders.
click here to find a list of Estramustine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Estramustine DMF (Drug Master File) is a document detailing the whole manufacturing process of Estramustine active pharmaceutical ingredient (API) in detail. Different forms of Estramustine DMFs exist exist since differing nations have different regulations, such as Estramustine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estramustine DMF submitted to regulatory agencies in the US is known as a USDMF. Estramustine USDMF includes data on Estramustine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estramustine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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