01 2Cleave Therapeutics
01 1CB 5339 DRUG SUBSTANCE
02 1CB-5339 DRUG PRODUCT
01 2U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34023
Submission : 2019-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34034
Submission : 2019-09-06
Status : Active
Type : II
A CB-5339 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CB-5339, including repackagers and relabelers. The FDA regulates CB-5339 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CB-5339 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 CB-5339 supplier is an individual or a company that provides CB-5339 active pharmaceutical ingredient (API) or CB-5339 finished formulations upon request. The CB-5339 suppliers may include CB-5339 API manufacturers, exporters, distributors and traders.
click here to find a list of CB-5339 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CB-5339 DMF (Drug Master File) is a document detailing the whole manufacturing process of CB-5339 active pharmaceutical ingredient (API) in detail. Different forms of CB-5339 DMFs exist exist since differing nations have different regulations, such as CB-5339 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CB-5339 DMF submitted to regulatory agencies in the US is known as a USDMF. CB-5339 USDMF includes data on CB-5339's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CB-5339 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CB-5339 suppliers with USDMF on PharmaCompass.
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