01 2Mitsubishi Corporation
01 1CRUDE REPIRINAST (MY-5116)
02 1REPIRINAST (MY-5116) DRUG SUBSTANCE, KASHIMA-GUN, JAPAN
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7711
Submission : 1988-10-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8564
Submission : 1990-05-14
Status : Inactive
Type : II
A Repirinast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Repirinast, including repackagers and relabelers. The FDA regulates Repirinast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Repirinast 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 Repirinast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Repirinast supplier is an individual or a company that provides Repirinast active pharmaceutical ingredient (API) or Repirinast finished formulations upon request. The Repirinast suppliers may include Repirinast API manufacturers, exporters, distributors and traders.
click here to find a list of Repirinast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Repirinast DMF (Drug Master File) is a document detailing the whole manufacturing process of Repirinast active pharmaceutical ingredient (API) in detail. Different forms of Repirinast DMFs exist exist since differing nations have different regulations, such as Repirinast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Repirinast DMF submitted to regulatory agencies in the US is known as a USDMF. Repirinast USDMF includes data on Repirinast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Repirinast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Repirinast suppliers with USDMF on PharmaCompass.
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