01 1Shionogi
01 1COMPOUND 7432-S
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6883
Submission : 1987-03-18
Status : Inactive
Type : II
A CAS-97519-39-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-97519-39-6, including repackagers and relabelers. The FDA regulates CAS-97519-39-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-97519-39-6 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CAS-97519-39-6 supplier is an individual or a company that provides CAS-97519-39-6 active pharmaceutical ingredient (API) or CAS-97519-39-6 finished formulations upon request. The CAS-97519-39-6 suppliers may include CAS-97519-39-6 API manufacturers, exporters, distributors and traders.
click here to find a list of CAS-97519-39-6 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CAS-97519-39-6 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-97519-39-6 active pharmaceutical ingredient (API) in detail. Different forms of CAS-97519-39-6 DMFs exist exist since differing nations have different regulations, such as CAS-97519-39-6 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-97519-39-6 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-97519-39-6 USDMF includes data on CAS-97519-39-6's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-97519-39-6 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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