Introducing TopChem Pharma

TopChem Pharmaceuticals Limited was established in 2006 as a new GMP manufacturer of APIs and related support services to the Pharmaceuticals sector worldwide. TopChem is targeting niche, low-volume APIs and excipients that are often difficult to source by Drug Product companies.

Our Products

The Products page shows the range of products we have developed. Please contact us if you have an API or Excipient that you cannot find. Most of our products have been developed in response to specific customer demand. We can offer global or territory exclusivity if required.

TopChem Pharma has successfully passed GMP inspections by the US FDA and EU regulatory authorities. All our products are manufactured in our GMP facility in Sligo, Ireland.

TopChem operates to the highest international Quality, Safety and Environmental standards.

  • If you have any questions or would like to contact TopChem Pharma, our address and telephone details are as follows:

Dr Donal Coveney
TopChem Pharmaceuticals Limited
Ballymote Business Park
Carrownanty, Ballymote
County Sligo, Ireland
Tel. +353 71 918 9685
Fax +353 71 919 7864

Contact Us

Chemist in QC laboratoryChemist

QC Laboratory [left] and API Purification [right]

 

News

  • January 2021: 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.
  • October 2020: A second shipment of Covid-19 test reagent was supplied to Sligo University Hospital to support the testing laboratory at our local hospital.
  • April 2020: We are delighted to have supplied the first lot of Covid-19 test reagent (guanidinium thiocyanate lysis buffer) to Sligo University Hospital. TopChem produced this reagent at cost and we are very pleased to be able support the national effort in our small way in these difficult times.
  • October 2019: Adenine. Our latest new product has shipped to an international customer.
  • October 2019: We are pleased to announce the commencement of the expansion of our R&D laboratories to strengthen our research capabilities and to support our growing global business.
  • February 2019: Bretylium Tosylate ANDA Approved in the US. We are delighted with the recent news of the approval of the Bretylium Tosylate ANDA #204386 sponsored by our partner Academic Pharmaceuticals Inc. The drug product will be manufactured by PII. TopChem Pharmaceuticals Ltd is the exclusive supplier of the Active Ingredient and we look forward to working with our partners to bring this life-saving medicine back to the US market. Dr John Somberg, CEO of Academic stated that "TopChem was instrumental in making this critical active ingredient available to the exceptionally high quality standards required".

News Archive