01 1Sumitomo Pharma
01 1AT-4140
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8375
Submission : 1990-01-16
Status : Inactive
Type : II
95
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A Zagam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zagam, including repackagers and relabelers. The FDA regulates Zagam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zagam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Zagam supplier is an individual or a company that provides Zagam active pharmaceutical ingredient (API) or Zagam finished formulations upon request. The Zagam suppliers may include Zagam API manufacturers, exporters, distributors and traders.
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A Zagam DMF (Drug Master File) is a document detailing the whole manufacturing process of Zagam active pharmaceutical ingredient (API) in detail. Different forms of Zagam DMFs exist exist since differing nations have different regulations, such as Zagam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zagam DMF submitted to regulatory agencies in the US is known as a USDMF. Zagam USDMF includes data on Zagam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zagam USDMF is kept confidential to protect the manufacturer’s intellectual property.
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