TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1ALP Pharm
03 1AmbioPharm
04 1Chengdu Shengnuo Biopharm
05 1Hainan Shuangcheng Pharmaceuticals
06 1Hybio Pharmaceutical
07 2Jiangsu Sinopep Allsino Biopharmaceutical
08 2PolyPeptide Group
09 1SHENZHEN SALUBRIS PHARMACEUTICALS
10 1ScinoPharm Taiwan Ltd
11 1Sun Pharmaceutical Industries Limited
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20863
Submission : 2007-09-18
Status :
Type : II
21
PharmaCompass offers a list of Bivalirudin 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 Bivalirudin manufacturer or Bivalirudin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bivalirudin manufacturer or Bivalirudin supplier.
PharmaCompass also assists you with knowing the Bivalirudin API Price utilized in the formulation of products. Bivalirudin API Price is not always fixed or binding as the Bivalirudin Price is obtained through a variety of data sources. The Bivalirudin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bivalirudin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bivalirudin, including repackagers and relabelers. The FDA regulates Bivalirudin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bivalirudin 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 Bivalirudin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bivalirudin supplier is an individual or a company that provides Bivalirudin active pharmaceutical ingredient (API) or Bivalirudin finished formulations upon request. The Bivalirudin suppliers may include Bivalirudin API manufacturers, exporters, distributors and traders.
click here to find a list of Bivalirudin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bivalirudin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bivalirudin active pharmaceutical ingredient (API) in detail. Different forms of Bivalirudin DMFs exist exist since differing nations have different regulations, such as Bivalirudin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bivalirudin DMF submitted to regulatory agencies in the US is known as a USDMF. Bivalirudin USDMF includes data on Bivalirudin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bivalirudin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bivalirudin suppliers with USDMF on PharmaCompass.
We have 11 companies offering Bivalirudin
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