01 1Sichuan Kelun Pharmaceutical
01 1PEMAFIBRATE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42059
Submission : 2025-06-17
Status : Active
Type : II
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PharmaCompass offers a list of Pemafibrate 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 Pemafibrate manufacturer or Pemafibrate supplier for your needs.
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A Pemafibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemafibrate, including repackagers and relabelers. The FDA regulates Pemafibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemafibrate 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 Pemafibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pemafibrate supplier is an individual or a company that provides Pemafibrate active pharmaceutical ingredient (API) or Pemafibrate finished formulations upon request. The Pemafibrate suppliers may include Pemafibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pemafibrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pemafibrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemafibrate active pharmaceutical ingredient (API) in detail. Different forms of Pemafibrate DMFs exist exist since differing nations have different regulations, such as Pemafibrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemafibrate DMF submitted to regulatory agencies in the US is known as a USDMF. Pemafibrate USDMF includes data on Pemafibrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemafibrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemafibrate suppliers with USDMF on PharmaCompass.
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