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 Camsylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rucaparib Camsylate, including repackagers and relabelers. The FDA regulates Rucaparib Camsylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rucaparib Camsylate 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 Camsylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rucaparib Camsylate supplier is an individual or a company that provides Rucaparib Camsylate active pharmaceutical ingredient (API) or Rucaparib Camsylate finished formulations upon request. The Rucaparib Camsylate suppliers may include Rucaparib Camsylate API manufacturers, exporters, distributors and traders.
click here to find a list of Rucaparib Camsylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rucaparib Camsylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rucaparib Camsylate active pharmaceutical ingredient (API) in detail. Different forms of Rucaparib Camsylate DMFs exist exist since differing nations have different regulations, such as Rucaparib Camsylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rucaparib Camsylate DMF submitted to regulatory agencies in the US is known as a USDMF. Rucaparib Camsylate USDMF includes data on Rucaparib Camsylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rucaparib Camsylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rucaparib Camsylate suppliers with USDMF on PharmaCompass.
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