News Archive

Our latest News is on the home page and older news items are shown below.


  • 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".


  • 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.

2013 - 2015

  • November 2015: Our Managing Director, Donal Coveney was awarded Industrial Chemist of the Year 2015 by the Institute of Chemistry of Ireland. Donal commented "I was delighted to receive this award from the Institute in its inaugural year. Many thanks to the generous sponsors, Henkel Ireland. It was a great pleasure to present my lecture at the Institute of Technology Sligo and at University College Dublin where I shared some of the technical challenges we faced at TopChem in gaining approval for our products". He acknowledged the contributions of the team of chemists at TopChem both past and present in these product developments. We thank the Institute of Chemistry of Ireland for introducing this new award which serves to acknowledge achievements by Irish chemists working in industry.
  • October 2015: Following our first shipments to South Korea, TopChem demonstrates an increasing global reach. We are now supplying markets in North America, Europe, Asia and the Middle East.
  • September 2015: Chromic chloride hexahydrate - our latest commercial product has shipped to a major pharma customer. This is another trace element ingredient used in total parenteral nutrition. We are pleased to add another critical care product to our portfolio.
  • June 2015: TopChem Pharma ships the first commercial batches of Piribedil API. Piribedil is a dopamine agonist used in the treatment of Parkinsons disease.
  • May 2015: We are pleased to announce that we have passed our second EU GMP inspection which underlines our ongoing commitment to maintaining the highest quality standards.
  • February 2015: TopChem Pharma ships the first commercial lot of Selenious Acid. Selenious acid is used as an essential trace element in total parenteral nutrition.
  • June 2014: TopChem files a US Drug Master File for Tolcapone API.
  • May 2013: TopChem passes second US FDA inspection with no 483 citations.

2006 - 2012

  • October 2012: TopChem Pharma is pleased to announce that we have passed our first EU GMP inspection.
  • August 2012: TopChem Pharma appoints Ms. Frances King as QA Manager. Frances brings a wealth of experience to the team with her previous employment in Quality roles in Abbot and Elan.
  • July 2012: TopChem Pharma files a US Drug Master file for Bretylium Tosylate.
  • June 2012: TopChem Pharma files a US Drug Master file for Ethacrynic Acid.
  • January 2012: TopChem Pharma ships first commercial batches of Thiamine Hydrochloride.
  • December 2011: TopChem Pharma files Bretylium Tosylate API to Health Canada.
  • November 2010: TopChem Pharma is shortlisted in two categories for the Irish Exporter of the Year Awards 2010.
  • August 2009: TopChem Pharma passes first US FDA inspection.
  • April 2008: First batches of high purity Benzyl Benzoate shipped.
  • March 2008. TopChem Pharma files a US Drug Master file for Malathion.
  • August 2007: First batches of Malathion shipped from the new TopChem Pharma facility in Sligo, Ireland.
  • May 2007: TopChem Pharma moves into purpose built facility in Sligo, Ireland.
  • September 2006: TopChem Pharma announces our intention to establish a new API facility in Ireland.

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