Our recent US Patent 10836705 details our proprietary process for the manufacture of very high purity Bretylium Tosylate.
TopChem is the only US approved manufacturer of this API. Bretylium Tosylate Injection is indicated in the prophylaxis and therapy of ventricular fibrillation. Bretylium Tosylate Injection is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia that have failed to respond to a first-line antiarrhythmic agent, such as lidocaine. This product had been off the market for many years due to the lack of availability of the API.
Dr John Somberg, an eminent US cardiologist has been instrumental in bringing this life-saving medicine back to the US market. TopChem collaborated with Dr Somberg and the drug product manufacturing partner, Pharmaceutics International Inc. to secure the US approval and relaunch of Bretylium Tosylate in the US market.