TopChem Pharmaceuticals is a manufacturer of pharmaceutical active ingredients (APIs), excipients and other cGMP materials, based in the North West of Ireland.
All our products are developed, manufactured and tested in our US FDA inspected and EU cGMP certified facility in County Sligo. Our focus is on the export market with the majority of our business in North America, but also in the EU and to a lesser extent, the Middle East and Asia. Our niche market is the low volume products that are of little interest to the majority of API manufacturers. Our products range from hundreds of grams to hundreds of kilos per annum.
We are an independent SME and since our establishment in 2007, we have developed a range of products covering a wide selection of critical-care and other therapeutic applications. TopChem are experts in the development of process technology to manufacture very high purity pharma grade products. This has led to the development of proprietary intellectual property.
For example, our 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.
TopChem will continue to develop active ingredients for use in NCE, generic and repurposed drugs for the global market.
For further information on the work of TopChem Pharmaceuticals, please visit our website here