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