01 1MSN Laboratories
01 1BETRIXABAN MALEATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34655
Submission : 2020-02-29
Status : Active
Type : II
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PharmaCompass offers a list of Betrixaban Maleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Betrixaban Maleate manufacturer or Betrixaban Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betrixaban Maleate manufacturer or Betrixaban Maleate supplier.
A Betrixaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betrixaban, including repackagers and relabelers. The FDA regulates Betrixaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betrixaban 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 Betrixaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Betrixaban supplier is an individual or a company that provides Betrixaban active pharmaceutical ingredient (API) or Betrixaban finished formulations upon request. The Betrixaban suppliers may include Betrixaban API manufacturers, exporters, distributors and traders.
click here to find a list of Betrixaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Betrixaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Betrixaban active pharmaceutical ingredient (API) in detail. Different forms of Betrixaban DMFs exist exist since differing nations have different regulations, such as Betrixaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betrixaban DMF submitted to regulatory agencies in the US is known as a USDMF. Betrixaban USDMF includes data on Betrixaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betrixaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betrixaban suppliers with USDMF on PharmaCompass.
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