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