01 2Otsuka Chemical Co Ltd
01 1PROCATEROL HYDROCHLORIDE HEMIHYDRATE
02 1PROCATEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4820
Submission : 1983-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3606
Submission : 1979-09-19
Status : Inactive
Type : II
100
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A CI888 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CI888, including repackagers and relabelers. The FDA regulates CI888 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CI888 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 CI888 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A CI888 supplier is an individual or a company that provides CI888 active pharmaceutical ingredient (API) or CI888 finished formulations upon request. The CI888 suppliers may include CI888 API manufacturers, exporters, distributors and traders.
click here to find a list of CI888 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CI888 DMF (Drug Master File) is a document detailing the whole manufacturing process of CI888 active pharmaceutical ingredient (API) in detail. Different forms of CI888 DMFs exist exist since differing nations have different regulations, such as CI888 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CI888 DMF submitted to regulatory agencies in the US is known as a USDMF. CI888 USDMF includes data on CI888's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CI888 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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