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