AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Lee Pharma
01 2MIROGABALIN BESYLATE
01 2India
01 2Active
01 2Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
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
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PharmaCompass offers a list of Mirogabalin Besilate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mirogabalin Besilate manufacturer or Mirogabalin Besilate supplier for your needs.
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PharmaCompass also assists you with knowing the Mirogabalin Besilate API Price utilized in the formulation of products. Mirogabalin Besilate API Price is not always fixed or binding as the Mirogabalin Besilate Price is obtained through a variety of data sources. The Mirogabalin Besilate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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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.
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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.
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