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 N0837 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N0837, including repackagers and relabelers. The FDA regulates N0837 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N0837 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 N0837 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A N0837 supplier is an individual or a company that provides N0837 active pharmaceutical ingredient (API) or N0837 finished formulations upon request. The N0837 suppliers may include N0837 API manufacturers, exporters, distributors and traders.
click here to find a list of N0837 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A N0837 DMF (Drug Master File) is a document detailing the whole manufacturing process of N0837 active pharmaceutical ingredient (API) in detail. Different forms of N0837 DMFs exist exist since differing nations have different regulations, such as N0837 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N0837 DMF submitted to regulatory agencies in the US is known as a USDMF. N0837 USDMF includes data on N0837's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N0837 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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