01 1Maithri Drugs
01 1AVACOPAN
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40159
Submission : 2024-06-29
Status : Active
Type : II
A Avacopan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avacopan, including repackagers and relabelers. The FDA regulates Avacopan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avacopan 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 Avacopan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avacopan supplier is an individual or a company that provides Avacopan active pharmaceutical ingredient (API) or Avacopan finished formulations upon request. The Avacopan suppliers may include Avacopan API manufacturers, exporters, distributors and traders.
click here to find a list of Avacopan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avacopan DMF (Drug Master File) is a document detailing the whole manufacturing process of Avacopan active pharmaceutical ingredient (API) in detail. Different forms of Avacopan DMFs exist exist since differing nations have different regulations, such as Avacopan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avacopan DMF submitted to regulatory agencies in the US is known as a USDMF. Avacopan USDMF includes data on Avacopan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avacopan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avacopan suppliers with USDMF on PharmaCompass.
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