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

  • 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".
  • April 2018: TopChem exhibits at the second CPhI North America in Philadelphia.
  • April 2018: Our first commercial product shipment to Saudi Arabia.
  • October 2017: TopChem celebrates the ten year anniversary of our first product shipment from our Ballymote facility. Our thanks to all our current and former colleagues for all their hard work in reaching this milestone. We also thank our customers for their continued support during these first ten years of operation.
  • June 2017: TopChem granted US patent. Chairman of the Board, Dr Paul Stenson commented: "TopChem Pharmaceuticals regards Intellectual Property as a tangible asset that brings value to TopChem and our customers and we are pleased to be granted US Patent 9663507 for the Crystallisation of Thiamine hydrochloride. TopChem will continue to develop and secure new Intellectual Property in the development of our API's for the global market".
  • May 2017: TopChem exhibits at the inaugural CPhI North America in Philadelphia.
  • October 2016: TopChem ships first quantities of Isoniazid suitable for use in injectable drug products.
  • September 2016: We are exhibiting at CPhI Worldwide which takes place in Barcelona from October 4th to 6th. Please visit us at the Irish Pavilion Stand number 1K20.
  • August 2016: We are pleased to announce that we have passed our third US FDA inspection.

News Archive