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01 1Ami Lifesciences Private Limited
02 1Lee Pharma
01 2MIROGABALIN BESYLATE
01 2India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38908
Submission : 2023-09-20
Status : Active
Type : II
A Mirogabalin Besilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin Besilate, including repackagers and relabelers. The FDA regulates Mirogabalin Besilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin Besilate 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 Mirogabalin Besilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin Besilate supplier is an individual or a company that provides Mirogabalin Besilate active pharmaceutical ingredient (API) or Mirogabalin Besilate finished formulations upon request. The Mirogabalin Besilate suppliers may include Mirogabalin Besilate API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin Besilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin Besilate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin Besilate active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin Besilate DMFs exist exist since differing nations have different regulations, such as Mirogabalin Besilate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin Besilate DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin Besilate USDMF includes data on Mirogabalin Besilate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin Besilate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin Besilate suppliers with USDMF on PharmaCompass.
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