01 1Natco Pharma
01 1CAPMATINIB HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-10
Pay. Date : 2024-03-13
DMF Number : 39644
Submission : 2024-03-21
Status : Active
Type : II
A Capmatinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Capmatinib Hydrochloride, including repackagers and relabelers. The FDA regulates Capmatinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Capmatinib Hydrochloride 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 Capmatinib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Capmatinib Hydrochloride supplier is an individual or a company that provides Capmatinib Hydrochloride active pharmaceutical ingredient (API) or Capmatinib Hydrochloride finished formulations upon request. The Capmatinib Hydrochloride suppliers may include Capmatinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Capmatinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Capmatinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Capmatinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Capmatinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Capmatinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Capmatinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Capmatinib Hydrochloride USDMF includes data on Capmatinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Capmatinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Capmatinib Hydrochloride suppliers with USDMF on PharmaCompass.
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