01 1Apicore
02 1MSN Laboratories
03 1Blank
01 3BELZUTIFAN
01 2India
02 1Blank
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-01
Pay. Date : 2025-05-27
DMF Number : 41515
Submission : 2025-05-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-15
Pay. Date : 2025-03-28
DMF Number : 41469
Submission : 2025-03-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-29
Pay. Date : 2025-03-26
DMF Number : 41423
Submission : 2025-03-26
Status : Active
Type : II
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PharmaCompass offers a list of Belzutifan 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 Belzutifan manufacturer or Belzutifan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Belzutifan manufacturer or Belzutifan supplier.
A Belzutifan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Belzutifan, including repackagers and relabelers. The FDA regulates Belzutifan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Belzutifan 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 Belzutifan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Belzutifan supplier is an individual or a company that provides Belzutifan active pharmaceutical ingredient (API) or Belzutifan finished formulations upon request. The Belzutifan suppliers may include Belzutifan API manufacturers, exporters, distributors and traders.
click here to find a list of Belzutifan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Belzutifan DMF (Drug Master File) is a document detailing the whole manufacturing process of Belzutifan active pharmaceutical ingredient (API) in detail. Different forms of Belzutifan DMFs exist exist since differing nations have different regulations, such as Belzutifan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Belzutifan DMF submitted to regulatory agencies in the US is known as a USDMF. Belzutifan USDMF includes data on Belzutifan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Belzutifan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Belzutifan suppliers with USDMF on PharmaCompass.
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