01 1Chugai Pharmaceutical
01 1SG-75 (NICORANDIL) BULK DRUG PRODUCT
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6716
Submission : 1986-12-11
Status : Inactive
Type : II
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A Sigmart manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sigmart, including repackagers and relabelers. The FDA regulates Sigmart manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sigmart 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 Sigmart manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sigmart supplier is an individual or a company that provides Sigmart active pharmaceutical ingredient (API) or Sigmart finished formulations upon request. The Sigmart suppliers may include Sigmart API manufacturers, exporters, distributors and traders.
click here to find a list of Sigmart suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sigmart DMF (Drug Master File) is a document detailing the whole manufacturing process of Sigmart active pharmaceutical ingredient (API) in detail. Different forms of Sigmart DMFs exist exist since differing nations have different regulations, such as Sigmart USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sigmart DMF submitted to regulatory agencies in the US is known as a USDMF. Sigmart USDMF includes data on Sigmart's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sigmart USDMF is kept confidential to protect the manufacturer’s intellectual property.
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