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