Alchem International commits to tropane alkaloid APIs to resolve supply gap

Following the decision by the principal European manufacturers to exit or end market development and regulatory support for the niche range of tropane alkaloid active pharmaceutical ingredients (APIs) - including atropine, atropine sulfate, tropine, nortropine, homatropine methylbromide, homatropine hydrobromide, digoxin and cimetropium bromide, India-headquartered family-owned drugmaker Alchem International has confirmed its commitment to maintain production and regulatory (Drug Master File) support from its Good Manufacturing Practice (GMP) production units.

Raman Mehta, chief executive and president at Alchem International, said: "Whilst the tropane alkaloid family of APIs is a specialist business and difficult to manage within larger scale production facilities, Alchem International has invested in a suite of bespoke manufacturing and regulatory capabilities to support smaller scale, as well as, large scale API production and dossier support."

Mr Mehta continued: "At short notice, Alchem International's R&D and regulatory teams have worked against the clock to provide a solution to our partner customers to resolve the supply gap and consequentially a potential withdrawal of these medicines from the market. This has been a significant undertaking and one we are proud to make, because we understand that, for customers, consistent supply of all APIs is vital, not only the mainstream ones."