01 1Guangdong Raffles PharmaTech Co Ltd
01 1DABRAFENIB MESYLATE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43177
Submission : 2025-12-31
Status : Active
Type : II
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PharmaCompass offers a list of Dabrafenib Mesylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dabrafenib Mesylate manufacturer or Dabrafenib Mesylate supplier for your needs.
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A Dabrafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabrafenib, including repackagers and relabelers. The FDA regulates Dabrafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabrafenib 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 Dabrafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dabrafenib supplier is an individual or a company that provides Dabrafenib active pharmaceutical ingredient (API) or Dabrafenib finished formulations upon request. The Dabrafenib suppliers may include Dabrafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Dabrafenib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dabrafenib DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabrafenib active pharmaceutical ingredient (API) in detail. Different forms of Dabrafenib DMFs exist exist since differing nations have different regulations, such as Dabrafenib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabrafenib DMF submitted to regulatory agencies in the US is known as a USDMF. Dabrafenib USDMF includes data on Dabrafenib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabrafenib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dabrafenib suppliers with USDMF on PharmaCompass.
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