China Quality Inspection for Sofosbuvir Daclatasvir Dose - Dabigatran Etexilate Mesylate – CPF manufacturers and suppliers

Quality Inspection for Sofosbuvir Daclatasvir Dose - Dabigatran Etexilate Mesylate – CPF

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Quality Inspection for Sofosbuvir Daclatasvir Dose - 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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We have advanced equipment. Our products are exported to the USA, the UK and so on, enjoying a good reputation among customers for Quality Inspection for Sofosbuvir Daclatasvir Dose - Dabigatran Etexilate Mesylate – CPF , The product will supply to all over the world, such as: Maldives, The Swiss, Kyrgyzstan, Our professional engineering group will always be ready to serve you for consultation and feedback. We're able to also offer you with absolutely free samples to meet your requirements. Finest efforts will likely be produced to offer you the ideal service and goods. For anyone who is thinking about our company and merchandise, be sure to contact us by sending us emails or contact us quickly. As a way to know our merchandise and firm. lot more, you can come to our factory to find out it. We'll always welcome guests from all over the world to our business to build company relations with us. Be sure to feel free to get in touch with us for business and we believe we've been intending to share the top trading practical experience with all our merchants.

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