01 1KYORIN PHARMACEUTICAL CO LTD
01 1KRP-297
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16754
Submission : 2003-08-11
Status : Inactive
Type : II
A Benzamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzamide, including repackagers and relabelers. The FDA regulates Benzamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzamide supplier is an individual or a company that provides Benzamide active pharmaceutical ingredient (API) or Benzamide finished formulations upon request. The Benzamide suppliers may include Benzamide API manufacturers, exporters, distributors and traders.
click here to find a list of Benzamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzamide active pharmaceutical ingredient (API) in detail. Different forms of Benzamide DMFs exist exist since differing nations have different regulations, such as Benzamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzamide DMF submitted to regulatory agencies in the US is known as a USDMF. Benzamide USDMF includes data on Benzamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzamide suppliers with USDMF on PharmaCompass.
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