ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Reset all filters
01 1ChemWerth Inc
02 1LGM Pharma
03 1Omgene Life Sciences Pvt. Ltd
04 1TAPI Technology & API Services
05 1ALP Pharm
06 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
07 1AmbioPharm
08 1Chengdu Shengnuo Biopharm
09 1Guangzhou Tosun Pharmaceutical
10 1Hainan Shuangcheng Pharmaceuticals
11 1Hybio Pharmaceutical
12 2Jiangsu Sinopep Allsino Biopharmaceutical
13 1Jin Dun Medical
14 1Patheon
15 2PolyPeptide Group
16 1SHENZHEN SALUBRIS PHARMACEUTICALS
17 1Sajjala Bio Labs
18 1Sandoz B2B
19 1ScinoPharm Taiwan Ltd
20 1Shenzhen JYMed Technology
21 1Smaart Pharmaceutticals
22 1Sun Pharmaceutical Industries Limited
23 1Teva Pharmaceutical Industries
24 1Blank
Reset all filters
01 11China
02 4India
03 2Israel
04 3Switzerland
05 1Taiwan
06 4U.S.A
07 1Blank
Reset all filters
01 9Active
02 4Inactive
03 13Blank
01 26Blank
Reset all filters
01 26Blank
Reset all filters
01 1WC-0159nA2
02 25Blank
Reset all filters
01 26Blank
Reset all filters
01 10781-3453
02 132861-0001
03 141524-0001
04 152958-112
05 162756-051
06 165129-1225
07 168225-041
08 176177-001
09 176177-333
10 17Blank
01 26Blank
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 : 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 : 2015-12-16
Pay. Date : 2015-08-20
DMF Number : 25634
Submission : 2011-12-27
Status : Active
Type : II
NDC Package Code : 65129-1225
Start Marketing Date : 2010-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

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 : 2016-08-04
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

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.
We have 23 companies offering Bivalirudin
Get in contact with the supplier of your choice: