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01 1BELUMOSUDIL MESYLATE
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40514
Submission : 2024-09-29
Status : Active
Type : II
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A Belumosudil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Belumosudil, including repackagers and relabelers. The FDA regulates Belumosudil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Belumosudil 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 Belumosudil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Belumosudil supplier is an individual or a company that provides Belumosudil active pharmaceutical ingredient (API) or Belumosudil finished formulations upon request. The Belumosudil suppliers may include Belumosudil API manufacturers, exporters, distributors and traders.
click here to find a list of Belumosudil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Belumosudil DMF (Drug Master File) is a document detailing the whole manufacturing process of Belumosudil active pharmaceutical ingredient (API) in detail. Different forms of Belumosudil DMFs exist exist since differing nations have different regulations, such as Belumosudil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Belumosudil DMF submitted to regulatory agencies in the US is known as a USDMF. Belumosudil USDMF includes data on Belumosudil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Belumosudil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Belumosudil suppliers with USDMF on PharmaCompass.
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