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
A Betrixaban Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betrixaban Maleate, including repackagers and relabelers. The FDA regulates Betrixaban Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betrixaban Maleate 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 Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betrixaban Maleate supplier is an individual or a company that provides Betrixaban Maleate active pharmaceutical ingredient (API) or Betrixaban Maleate finished formulations upon request. The Betrixaban Maleate suppliers may include Betrixaban Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Betrixaban Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betrixaban Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Betrixaban Maleate active pharmaceutical ingredient (API) in detail. Different forms of Betrixaban Maleate DMFs exist exist since differing nations have different regulations, such as Betrixaban Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betrixaban Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Betrixaban Maleate USDMF includes data on Betrixaban Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betrixaban Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betrixaban Maleate suppliers with USDMF on PharmaCompass.
We have 1 companies offering Betrixaban Maleate
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?