Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1TAPI Technology & API Services
03 1ALP Pharm
04 1AmbioPharm
05 1Chengdu Shengnuo Biopharm
06 1Hainan Shuangcheng Pharmaceuticals
07 1Hybio Pharmaceutical
08 2Jiangsu Sinopep Allsino Biopharmaceutical
09 2PolyPeptide Group
10 1SHENZHEN SALUBRIS PHARMACEUTICALS
11 1ScinoPharm Taiwan, Ltd
12 1Sun Pharmaceutical Industries Limited
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31458
Submission : 2017-03-31
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20863
Submission : 2007-09-18
Status :
Type : II
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 12 companies offering Bivalirudin
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
