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
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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 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, COA and API Price 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, COA and API Price related information on PharmaCompass.
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