01 1Sumitomo Pharma
01 1RANIRESTAT (AS-3201)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21445
Submission : 2008-03-19
Status : Inactive
Type : II
A Ranirestat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ranirestat, including repackagers and relabelers. The FDA regulates Ranirestat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ranirestat 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 Ranirestat supplier is an individual or a company that provides Ranirestat active pharmaceutical ingredient (API) or Ranirestat finished formulations upon request. The Ranirestat suppliers may include Ranirestat API manufacturers, exporters, distributors and traders.
click here to find a list of Ranirestat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ranirestat DMF (Drug Master File) is a document detailing the whole manufacturing process of Ranirestat active pharmaceutical ingredient (API) in detail. Different forms of Ranirestat DMFs exist exist since differing nations have different regulations, such as Ranirestat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ranirestat DMF submitted to regulatory agencies in the US is known as a USDMF. Ranirestat USDMF includes data on Ranirestat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ranirestat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ranirestat suppliers with USDMF on PharmaCompass.
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