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Good Wholesale Vendors Canagliflozin Hemihydrate - Dabigatran Etexilate Mesylate – CPF

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Good Wholesale Vendors Canagliflozin Hemihydrate - Dabigatran Etexilate Mesylate – CPF Detail:

Description

Dabigatran etexilate mesylate (BIBR 1048MS) is an orally active prodrug of Dabigatran. Dabigatran etexilate mesylate has anticoagulant effects and is used for the prophylaxis of venousthromboembolism and stroke due to atrial fibrillation.

Background

Description: IC50 Value: 4.5nM (Ki); 10nM(Thrombin-induced platelet aggregation) [1] Dabigatran is a reversible and selective, direct thrombin inhibitor (DTI) undergoing advanced clinical development as its orally active prodrug,dabigatran etexilate. in vitro: Dabigatran selectively and reversibly inhibited human thrombin(Ki: 4.5 nM) as well as thrombin-induced platelet aggregation (IC(50): 10 nM), while showing no inhibitory effect on other platelet-stimulating agents.Thrombin generation in platelet-poor plasma (PPP), measured as the endogenous thrombin potential (ETP) was inhibited concentration-dependently (IC(50): 0.56 microM). Dabigatran demonstrated concentration-dependent anticoagulant effects in various species in vitro, doubling the activated partial thromboplastin time (aPTT), prothrombin time (PT) and ecarin clotting time (ECT) in human PPP at concentrations of 0.23, 0.83 and 0.18 microM, respectively [1]. in vivo: Dabigatran prolonged the aPTT dose-dependently after intravenous administration in rats (0.3, 1 and 3 mg/kg) and rhesus monkeys (0.15, 0.3 and 0.6 mg/kg). Dose- and time-dependent anticoagulant effects were observed with dabigatran etexilate administered orally to conscious rats (10, 20 and 50 mg/kg) or rhesus monkeys (1, 2.5 or 5 mg/kg), with maximum effects observed between 30 and 120 min after administration, respectively [1]. Patients treated with dabigatran etexilate experienced fewer ischaemic strokes (3.74 dabigatran etexilate vs 3.97 warfarin) and fewer combined intracranial haemorrhages and haemorrhagic strokes (0.43 dabigatran etexilate vs 0.99 warfarin) per 100 patient-years [2]. Clinical trial: An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients . Phase1

Storage

Powder

-20°C

 3 years
 

4°C

 2 years
In solvent

-80°C

 6 months
 

-20°C

 1 month

Clinical Trial

NCT Number Sponsor Condition Start Date

Phase
NCT02170792 Boehringer Ingelheim Healthy February 2001

Phase 1
NCT02170974 Boehringer Ingelheim Healthy July 2004

Phase 1
NCT02170831 Boehringer Ingelheim Healthy May 1999

Phase 1
NCT02170805 Boehringer Ingelheim Healthy April 2001

Phase 1
NCT02170610 Boehringer Ingelheim Healthy March 2002

Phase 1
NCT02170909 Boehringer Ingelheim Healthy December 2004

Phase 1
NCT02171000 Boehringer Ingelheim Healthy April 2005

Phase 1
NCT02170844 Boehringer Ingelheim Healthy June 2004

Phase 1
NCT02170584 Boehringer Ingelheim Healthy January 2001

Phase 1
NCT02170935 Boehringer Ingelheim Venous Thromboembolism April 2002

Phase 2
NCT02170636 Boehringer Ingelheim Healthy January 2002

Phase 1
NCT02170766 Boehringer Ingelheim Healthy October 2000

Phase 1
NCT02171442 Boehringer Ingelheim Healthy April 2002

Phase 1
NCT02170896 Boehringer Ingelheim Healthy October 2001

Phase 1
NCT02173730 Boehringer Ingelheim Healthy November 2002

Phase 1
NCT02170623 Boehringer Ingelheim Healthy February 2002

Phase 1
NCT02170116 Boehringer Ingelheim Healthy November 1998

Phase 1
NCT02170597 Boehringer Ingelheim Healthy August 2003

Phase 1
NCT01225822 Boehringer Ingelheim Venous Thromboembolism November 2002

Phase 2
NCT02170701 Boehringer Ingelheim Venous Thromboembolism October 2000

Phase 2
NCT02170740 Boehringer Ingelheim Healthy November 1999

Phase 1
NCT02170922 Boehringer Ingelheim Healthy July 1999

Phase 1

Chemical structure

Dabigatran Etexilate Mesylate

2018 GMP-2
原料药GMP证书201811（captopril ,thalidomide etc）
GMP-of-PMDA-in-Chanyoo-平成28年08月03日　Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

OUR STRENGTH

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.


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International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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Good Wholesale Vendors Canagliflozin Hemihydrate - Dabigatran Etexilate Mesylate – CPF detail pictures

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Our eternal pursuits are the attitude of "regard the market, regard the custom, regard the science" as well as the theory of "quality the basic, believe in the 1st and management the advanced" for Good Wholesale Vendors Canagliflozin Hemihydrate - Dabigatran Etexilate Mesylate – CPF , The product will supply to all over the world, such as: Switzerland, Atlanta, Guyana, With the goal of "zero defect". To care for the environment, and social returns, care employee social responsibility as own duty. We welcome friends from all over the world to visit and guide us so that we can achieve the win-win goal together.
    • This is the first business after our company establish, products and services are very satisfying, we have a good start, we hope to cooperate continuous in the future!
    5 Stars By Nydia from Portugal - 2017.09.09 10:18
    With a positive attitude of "regard the market, regard the custom, regard the science", the company works actively to do research and development. Hope we have a future business relationships and achieving mutual success.
    5 Stars By Karen from Libya - 2017.06.25 12:48
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