01 1Formosa Laboratories
02 1MSN Laboratories
01 2RUCAPARIB CAMSYLATE
01 1India
02 1Taiwan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34419
Submission : 2019-12-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35585
Submission : 2021-01-30
Status : Active
Type : II
A Rucaparib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rucaparib, including repackagers and relabelers. The FDA regulates Rucaparib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rucaparib 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 Rucaparib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rucaparib supplier is an individual or a company that provides Rucaparib active pharmaceutical ingredient (API) or Rucaparib finished formulations upon request. The Rucaparib suppliers may include Rucaparib API manufacturers, exporters, distributors and traders.
click here to find a list of Rucaparib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rucaparib DMF (Drug Master File) is a document detailing the whole manufacturing process of Rucaparib active pharmaceutical ingredient (API) in detail. Different forms of Rucaparib DMFs exist exist since differing nations have different regulations, such as Rucaparib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rucaparib DMF submitted to regulatory agencies in the US is known as a USDMF. Rucaparib USDMF includes data on Rucaparib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rucaparib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rucaparib suppliers with USDMF on PharmaCompass.
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