loader
Please Wait
Applying Filters...
Close
4

Bora CDMO Bora CDMO

X

List of Drug Master Files (DMF) of Bivalirudin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email Product
Menu
Filters Filter
Cross PopUp
FILTER :

filter

01 Bachem AG (1)

02 Sun Pharmaceutical Industries Limited (1)

03 AmbioPharm (1)

04 Teva API (1)

05 ALP Pharm (1)

06 Chengdu Shengnuo Biopharm (1)

07 Hainan Shuangcheng Pharmaceuticals (1)

08 Hybio Pharmaceutical (1)

09 PolyPeptide Group (2)

10 SHENZHEN SALUBRIS PHARMACEUTICALS CO.LTD. (1)

11 ScinoPharm Taiwan, Ltd (1)

12 Sinopep Pharmaceutical Inc (2)

filter

01 BIVALIRUDIN (8)

02 BIVALIRUDIN (NON-STERILE BULK DRUG) (1)

03 BIVALIRUDIN (PROCESS II) (1)

04 BIVALIRUDIN (TM-001-2G) (1)

05 BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE (2)

06 HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT (1)

filter

01 China (7)

02 India (1)

03 Israel (1)

04 Switzerland (3)

05 Taiwan (1)

06 U.S.A (1)

filter

01 Active (12)

02 Inactive (2)

filter

01 Complete (7)

02 Blank (7)

URL Supplier Web Content
24423
Active
2011-01-15
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
20853
Active
2007-09-14
Complete
2013-05-30
2013-05-16
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
20863
Active
2007-09-18
Complete
2012-11-23
2012-11-13
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
24257
Active
2010-09-15
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
25531
Active
2012-05-14
Complete
2013-12-18
2013-08-13
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
30071
Active
2016-01-26
Complete
2016-08-04
2016-01-14
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
28912
Active
2014-12-05
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
12797
Active
1997-12-22
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
25634
Active
2011-12-27
Complete
2015-12-16
2015-08-20
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for 128270-60-0 / Bivalirudin API manufacturers, exporters & distributors?

Bivalirudin manufacturers, exporters & distributors 1

43

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.

API | Excipient name

Bivalirudin

Synonyms

128270-60-0, Angiomax, Bivalirudin trifluoroacetate, Bg-8967, Bg8967, Hirulog

Cas Number

128270-60-0

About Bivalirudin

Bivalirudin is a 20 amino acid long synthetic peptide with thrombin-specific anticoagulant properties. Bivalirudin reversibly binds thrombin, free as well as clot bound, at the catalytic site and the anion-binding exosite, thereby preventing the formation and activation of fibrin, factor XIIIa, and other coagulation factors. This drug is primarily used during coronary angioplasty procedures, in combination with aspirin, in patients with unstable angina.

Bivalirudin Manufacturers

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.

Bivalirudin Suppliers

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.

Bivalirudin USDMF

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.

Bivalirudin Manufacturers | Traders | Suppliers

Bivalirudin Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Post Enquiry
POST ENQUIRY