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