GENEVA, April 25, 2019 / PRNewswire / – Alchem International Private Limited (“Alchem”), a privately held pharmaceutical company specializing in the production of plant-derived active pharmaceutical ingredients (APIs), today announced the launch of its platform owner of micronized digoxin.
The Alchem molecule is the only micronized digoxin available worldwide that addresses the challenge of micro-dosing formulation and resolves the long-term impurity and stability issues associated with this heart drug. Digoxin is usually given to treat a variety of heart conditions, including atrial fibrillation, atrial flutter, and heart failure. The micronization of digoxin, normally performed to obtain the homogeneity, dissolution and biological availability of the formulation, had previously led to a short and impractical shelf life (between 12 and 24 months) and the formation of impurities .
Raman Mehta, CEO and President of Alchem, said from Alchem’s European offices in Geneva (Switzerland): “Our process innovations mean that, for the first time after Boehringer Ingelheim announced in 2014 the end of the Micronized digoxin production and its market supply, drug manufacturers can be assured of the supply and stability of this important niche IPA. Raman Mehta continued, “Our customers can now formulate digoxin at the optimal particle size distribution (PSD) with a molecule that is stable for transport, stable for storage for one year at room temperature (between 15 and 25 degrees Celsius) and stable for cold storage for 4 years (between 3 and 8 degrees Celsius).
Alchem’s micronized digoxin according to the European Pharmacopoeia, which was developed by the company’s R & D team using an inventive treatment technique (patent pending), complies with the strict monograph of the European Pharmacopoeia and is covered by the European Certificate of Conformity issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM). This inventive technique of production allowed us to match the phenolsulfonephthalein (PSP) of the original product Lanoxinat about the same production costs as our standard product, digoxin (non-micronized). The state-of-the-art production facility in Ballabhgarh, India has been audited and approved by the French Ministry of Health for the manufacture of digoxin on behalf of the EQDM.
About Alchem International
Alchem International is a private company founded in 1983. It is a pioneer company specializing in phytochemicals, with nearly 40 years of experience in providing derived active ingredients plants to the pharmaceutical, nutraceutical and cosmetic sectors all over the world.
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Media contact:
Robin Ward
Sales and Marketing Director – Alchem Europe SA
rward@alchemeurope.com
Tel. fixed: + 41-91-604-6921
Portable: + 41-79-682-6621
Related Links
http://www.alcheminternational.com/
SOURCE Alchem International
