GENEVA, Sept. 15, 2014 /PRNewswire/ — Following the decision by the principal European manufacturers to exit or end market development and regulatory support for the niche range of Tropane Alkaloid APIs (active pharmaceutical ingredients) – including Atropine, Atropine Sulfate, Tropine, Nortropine, Homatropine Methylbromide, Homatropine Hydrobromide, Digoxin and Cimetropium Bromide – Alchem International (http://www.alcheminternational.com) has confirmed commitment to maintain production and regulatory (Drug Master File) support from its GMP production units.
Raman Mehta, CEO and President at Alchem International, commented, "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."
Alchem International will be participating at CPHI Worldwide 2014 in Paris, the world’s leading pharmaceutical networking event, from the 6th of October 2014 to the 9th October, at stand 6T55
About Alchem International
Alchem International is a family-owned company, founded in 1935. A pioneer in phytochemicals, it has nearly 80 years’ experience in supplying plant-derived active ingredients to the pharmaceutical, nutraceutical and cosmetics industries worldwide. Alchem International employs 1,100 people across its four international divisions in India, Europe, the United States and Hong Kong. Alchem operates WHO and FDA GMP approved manufacturing sites in India, which export 90% of their production volumes. The company has 18 DMF dossiers with filings in over 20 countries worldwide. In addition to tropane alkaloids key products include Calcium sennosides, Colchicine, Enoxolone, Hysocine-N-Butlybromide, Nicotine, Thiocolchicoside and Vinpocetine.
Position. Business Development Director – Alchem International SA (Europe).