Morepen Laboratories receives USFDA approval for Fexofinadine Hydrochloride (Allegra)

Morepen Laboratories has received USFDA approval for its anti-allergy drug Fexofinadine Hydrochloride that is marketed in India under the popular brand name Allegra, among others and is the block buster drug of the innovator company Sanofi Aventis, France.

Fexofinadine is most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever.

The company has tied-up for regular supplies of Fexofinadine to one of its top US customers, with which the company has long standing relations lasting over two decades. The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches. Fexofinadine is a very established anti-allergy drug with a market size of around 700MT and expected to give immediate impetus to company's export business.

 

Morepen is the third largest exporters of this drug to the world and will move up in the ranks after this approval. The export of Fexofenadine to the highly regulated US market is expected to see multi-fold growth resulting in better profitability margins for the company. The company is having sufficient capacity to service the present demand and is also expanding capacities to become a leading player in the product in the coming years.

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