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Morepen gets USFDA approval for Desloratadine

Delhi 8th July ,   Morepen Laboratories has received US Food and Drug Administration (USFDA) approval for anti-allergic drug Desloratadine (Clarinex) for its manufacturing at Parwanoo (Masulkhana) 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 a estimated market size of around USD 300 million, Desloratadine is a very molecule in the anti-allergy segment. Due to 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 the producer of API (Active Pharmaceutical Ingredients) of Desloratadine in India while the finished dosage will be manufactured by US counterparts. Morepen has already done long term tie-ups for supply of Desloratadine in US market

“This is a significant move towards establishing our leadership in US market for anti-allergy drugs. Being the largest producer of generic Loratadine in the world, it gives us added advantage to lead the category” said Mr. Sushil Suri Chairman and Managing Director.

Morepen is the market leader of Loratadine in the world after the innovator, Schering Plough. It got the USFDA approval for Loratadine (Claritin) in the year 1999 and is regularly supplying to US market since 2003, to all top notch MNCs. With impeccable track record of quality and delivery Morepen is established as a preferred supplier for these large pharmaceutical Companies and had got more than 90% market share in US generic market. Morepen also has got significant presence in Europe and Eastern Europe Markets which is fast expanding.