Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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01 1Bachem AG
02 1ChemWerth Inc
03 1LGM Pharma
04 1Omgene Life Sciences Pvt. Ltd
05 1TAPI Technology & API Services
06 1ALP Pharm
07 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
08 1AmbioPharm
09 1Biopharm
10 1Chengdu Shengnuo Biopharm
11 1Guangzhou Tosun Pharmaceutical
12 1Hainan Shuangcheng Pharmaceuticals
13 1Hybio Pharmaceutical
14 2Jiangsu Sinopep Allsino Biopharmaceutical
15 1Jin Dun Medical
16 1Patheon
17 2PolyPeptide Group
18 1SHENZHEN SALUBRIS PHARMACEUTICALS
19 1Sajjala Bio Labs
20 1Sandoz B2B
21 1ScinoPharm Taiwan Ltd
22 1Shenzhen JYMed Technology
23 1Smaart Pharmaceutticals
24 1Sun Pharmaceutical Industries Limited
25 1Teva Pharmaceutical Industries
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01 11China
02 4India
03 2Israel
04 4Switzerland
05 1Taiwan
06 5U.S.A
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01 10Active
02 4Inactive
03 13Blank
01 27Blank
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01 27Blank
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01 1WC-0159nA2
02 26Blank
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01 27Blank
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01 10781-3453
02 132861-0001
03 141524-0001
04 152958-112
05 155463-0029
06 162756-051
07 165129-1225
08 168225-041
09 176177-001
10 176177-333
11 17Blank
01 27Blank
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 : Active
Type : II
NDC Package Code : 55463-0029
Start Marketing Date : 2012-03-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24423
Submission : 2011-01-15
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159nA2
Address of the Firm :
NDC Package Code : 62756-051
Start Marketing Date : 2025-03-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-03
Pay. Date : 2016-03-08
DMF Number : 30215
Submission : 2016-03-09
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-04
Pay. Date : 2016-01-14
DMF Number : 30071
Submission : 2016-01-26
Status : Active
Type : II
NDC Package Code : 52958-112
Start Marketing Date : 2019-10-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-09-19
DMF Number : 32281
Submission : 2018-06-29
Status : Active
Type : II
NDC Package Code : 76177-001
Start Marketing Date : 2018-01-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35259
Submission : 2020-09-30
Status : Inactive
Type : II
NDC Package Code : 76177-333
Start Marketing Date : 2018-01-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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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.
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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.
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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.
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We have 25 companies offering Bivalirudin
Get in contact with the supplier of your choice: