01 1Maithri Drugs
01 1MITAPIVAT SULFATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39774
Submission : 2024-03-31
Status : Active
Type : II
A Mitapivat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitapivat, including repackagers and relabelers. The FDA regulates Mitapivat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitapivat 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 Mitapivat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitapivat supplier is an individual or a company that provides Mitapivat active pharmaceutical ingredient (API) or Mitapivat finished formulations upon request. The Mitapivat suppliers may include Mitapivat API manufacturers, exporters, distributors and traders.
click here to find a list of Mitapivat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitapivat DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitapivat active pharmaceutical ingredient (API) in detail. Different forms of Mitapivat DMFs exist exist since differing nations have different regulations, such as Mitapivat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitapivat DMF submitted to regulatory agencies in the US is known as a USDMF. Mitapivat USDMF includes data on Mitapivat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitapivat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitapivat suppliers with USDMF on PharmaCompass.
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