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
16
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A Estracyt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estracyt, including repackagers and relabelers. The FDA regulates Estracyt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estracyt 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 Estracyt supplier is an individual or a company that provides Estracyt active pharmaceutical ingredient (API) or Estracyt finished formulations upon request. The Estracyt suppliers may include Estracyt API manufacturers, exporters, distributors and traders.
click here to find a list of Estracyt suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Estracyt DMF (Drug Master File) is a document detailing the whole manufacturing process of Estracyt active pharmaceutical ingredient (API) in detail. Different forms of Estracyt DMFs exist exist since differing nations have different regulations, such as Estracyt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estracyt DMF submitted to regulatory agencies in the US is known as a USDMF. Estracyt USDMF includes data on Estracyt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estracyt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estracyt suppliers with USDMF on PharmaCompass.
