English

Super Purchasing for Sofosbuvir Tablets - Dabigatran Etexilate Mesylate – CPF

Super Purchasing for Sofosbuvir Tablets - Dabigatran Etexilate Mesylate – CPF Featured Image
  • Super Purchasing for Sofosbuvir Tablets - Dabigatran Etexilate Mesylate – CPF

Short Description:


Product Detail

Product Tags

Related Video

Feedback (2)

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, have confidence in the very first and management the advanced" for Rosuvastatin Calcium 10mg Tablet, Captopril, Daclatasvir Dose, We warmly welcome all perspective inquiries from home and abroad to cooperate with us, and look forward to your correspondence.
Super Purchasing for Sofosbuvir Tablets - 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.


VIEW MORE


VIEW MORE

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

Product detail pictures:

Super Purchasing for Sofosbuvir Tablets - Dabigatran Etexilate Mesylate – CPF detail pictures

Related Product Guide:
"Sincerity, Innovation, Rigorousness, and Efficiency" may be the persistent conception of our organization for that long-term to establish jointly with customers for mutual reciprocity and mutual gain for Super Purchasing for Sofosbuvir Tablets - Dabigatran Etexilate Mesylate – CPF , The product will supply to all over the world, such as: Vietnam, Nicaragua, Chile, Item have passed by means of the national qualified certification and been well received in our main industry. Our expert engineering team will often be ready to serve you for consultation and feedback. We are able to also deliver you with cost-free samples to meet your specifications. Ideal efforts will probably be produced to provide you the most beneficial service and solutions. Should you be interested in our company and solutions, please make contact with us by sending us emails or call us straight away. To be able to know our solutions and enterprise. ar more, you'll be able to come to our factory to see it. We'll constantly welcome guests from all over the world to our firm. o build business enterprise. elations with us. Please feel absolutely free to speak to us for organization. nd we believe we will share the best trading practical experience with all our merchants.
    • The company's products very well, we have purchased and cooperated many times, fair price and assured quality, in short, this is a trustworthy company!
    5 Stars By Alice from New Delhi - 2017.09.30 16:36
    The factory has advanced equipment, experienced staffs and good management level, so product quality had assurance, this cooperation is very relaxed and happy!
    5 Stars By Dale from Czech republic - 2018.11.22 12:28
    Write your message here and send it to us

    Products categories