Morepen Laboratories receives USFDA approval for anti allergic drug -Desloratadine

09 Jul 2011 Evaluate

Morepen Laboratories has received US Food and Drug Administration (USFDA) approval for manufacturing its anti allergic drug Desloratadine (Clarinex) at Parwanoo (Malsulkhana) plant in Himachal Pradesh. Desloratadine market is likely to open for generic players in 2012.

Desloratadine is a non sedative anti-histamine drug and is an active metabolite of Loratadine which is widely accepted anti allergy drug in American markets. With the estimated market size of around $300 million, Desloratadine is a very molecule in the anti allergy segment.

Further, due to a very good safety data and mass use by consumers, ‘Loratadine’ was shifted in the year 2002 to OTC (Over the Counter) usage while Desloratadine remains a prescription product. Morepen is a producer of API (Active Pharmaceuticals Ingredients) of Desloratadine in India while the finished dosage will be manufactured by US counterparts. The company already established long term tie ups for supply of Desloratadine in US markets.

Morepen has a progressive lineage of manufacturing high quality generic drugs and Pharmaceutical formulations backed by a strong R&D, Regulatory and global marketing team. Morepen aims to provide sufficient visibility to its products and direct its business portfolio to the high value DMFs and ANDA driven International Export Business. Apart from leveraging its traditional strength in APIs, the Company is also concentrating on finished formulations in both regulated and non-regulated markets.

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