Clopidogrel Bisulfate

Clopidogrel Bisulfate is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It works by blocking a receptor called P2Y12. It is also used, along with aspirin, for the prevention of thromboembolism after placement of intra-coronary stent, PTCA and other invasive operations in the cardiovascular system.
 Clopidogrel Bisulfate is marketed by Bristol-Myers Squibb and Sanofi-Aventis under the brand name Plavix and considered to be blockbuster. Plavix tablets contain 97.875 mg of Clopidogrel Bisulfate which is the molar equivalent of 75 mg of Clopidogrel base.
Platelet aggregation is important in haemostasis (Blood Products Plasma Expanders and Haemostatics) and is also involved in thrombus formation, particularly in the arterial circulation. Anti-platelet drugs reduce platelet aggregation and are used to prevent further thromboembolic events in patients who have suffered myocardial infarction, ischaemic stroke or transient ischaemic attacks, or unstable angina, and for primary prevention of a thromboembolic event in patients at risk. Some are also used for the prevention of reocclusion or restenosis following angioplasty and bypass procedures. Anti-platelet drugs act through a wide range of mechanisms.

General data on Clopidogrel Bisulfate Active Pharmaceutical Ingredient

Molecular Weight: 419.9
CAS Registry: 113665-84-2 (clopidogrel);94188-84-8 (clopidogrel);120202-66-6 (clopidogrel bisulfate)
Pharmacopoeias: In US.
USP 29 (Clopidogrel Bisulfate): A white to off-white powder. Freely soluble in water and in methyl alcohol; practically insoluble in ether.
ATC:B01AC04
Clopidogrel Bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.

TAPI's Clopidogrel Bisulfate Pharmaceutical Ingredient

TAPI's Clopidogrel Bisulfate Active Pharmaceutical Ingredient is produced in Assia Industries Limited –Teva Tech site in Beer Sheva, Israel.

Clopidogrel Bisulfate is produced by organic synthesis and considered to be medium volume Active Pharmaceutical Ingredient.

 TAPI's Clopidogrel Bisulfate has unique features that might be advantage for final dosage development. TAPI has filed several patent applications for Clopidogrel Bisulfate.  Please, see table below for issued patents and pending applications.

Patent type	Description	App./publication/patent #	Status (date)
Polymorphic form	Novel crystal forms III, VI and novel amorphous form of clopidogrel hydrogensulfate	6,767,913	Issued 27/07/2004
		7,074,928	Issued 11/7/2006
	Hydrogensulfate form III	WO 03/051362 A2	Issued 26/3/2003
	Polymorphs of Clopidogrel Bisulphate	PCT/US07/017324	Pending 03/08/2007
Process	Racemization & enantiomer separation of Clopidogrel	6,737,411	Issued 18/05/2004
		6,800,759	Issued 5/10/2004
		WO2004013147	Pending 12/02/2004
		7,259,261	Issued 21/8/2007
Purity	Clopidogrel base free of residual solvents and impurities, as well as process for preparing thereof	WO2006091847	Pending 31/08/2006
		US20060223845	Pending 05/10/2006
Polymorphic form	Crystalline Optically Active Clopidogrel Hydrobromide	US20060154957	Pending 13/07/2006
		WO2006034451	Pending 30/03/2006

 Available DMFs from TAPI : USDMF , EU CTD

TAPI provides full service on this product and other APIs in our portfolio. We provide information on TAPI's Clopidogrel Bisulfate, the regulatory compliance with various health regulations and documentation. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Clopidogrel Bisulfate.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law.I n USA, Products  that  Currently on Patent are available for R&D Use in accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients