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