01 1Hangzhou Longshine Bio-Tech
02 1Hetero Drugs
03 1Jubilant Generics
04 1MSN Laboratories
05 1Nifty Labs
06 1Shanghai Hope Chem
07 1Viatris
08 1Zhejiang Ausun Pharmaceutical
01 3China
02 4India
03 1U.S.A
01 1Active
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01 8Blank
01 8Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34655
Submission : 2020-02-29
Status : Active
Type : II
NDC Package Code : 69766-087
Start Marketing Date : 2020-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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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.
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