01 1Sumitomo Pharma
01 1SMP-601 DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21025
Submission : 2007-11-07
Status : Inactive
Type : II
A Sm-216601 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sm-216601, including repackagers and relabelers. The FDA regulates Sm-216601 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sm-216601 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 Sm-216601 supplier is an individual or a company that provides Sm-216601 active pharmaceutical ingredient (API) or Sm-216601 finished formulations upon request. The Sm-216601 suppliers may include Sm-216601 API manufacturers, exporters, distributors and traders.
click here to find a list of Sm-216601 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sm-216601 DMF (Drug Master File) is a document detailing the whole manufacturing process of Sm-216601 active pharmaceutical ingredient (API) in detail. Different forms of Sm-216601 DMFs exist exist since differing nations have different regulations, such as Sm-216601 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sm-216601 DMF submitted to regulatory agencies in the US is known as a USDMF. Sm-216601 USDMF includes data on Sm-216601's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sm-216601 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sm-216601 suppliers with USDMF on PharmaCompass.
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