01 1RHODIA INC US 08512-7500 Cranbury
01 1METHOTRIMEPRAZINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 577
Submission : 1963-06-12
Status : Inactive
Type : II
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A Sofmin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofmin, including repackagers and relabelers. The FDA regulates Sofmin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofmin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sofmin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sofmin supplier is an individual or a company that provides Sofmin active pharmaceutical ingredient (API) or Sofmin finished formulations upon request. The Sofmin suppliers may include Sofmin API manufacturers, exporters, distributors and traders.
click here to find a list of Sofmin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sofmin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sofmin active pharmaceutical ingredient (API) in detail. Different forms of Sofmin DMFs exist exist since differing nations have different regulations, such as Sofmin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sofmin DMF submitted to regulatory agencies in the US is known as a USDMF. Sofmin USDMF includes data on Sofmin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sofmin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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