Morepen gets US FDA approval for Fexofinadine

Morepen Laboratories has received US Food and Drug Administration (FDA) approval for its anti-allergy drug Fexofinadine Hydrochloride that is marketed in India under the brand name Allegra, among others. Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever, the company said in a statement.

It also said that the company has tied up for regular supplies of Fexofinadine to one of its top US customers, with which it 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 an established anti-allergy drug with a market size of around 700MT, and is expected to give immediate impetus to the company’s export business.

Further, according to the statement, Morepen is the third-largest exporter 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.

Speaking in this regard, Sushil Suri, Chairman and Managing Director, Morepen Labs, stated, “Approval of anti-allergy drug Fexofinadine (Allegra) by US FDA is an important milestone in the company’s therapeutic journey since it consolidates Morepen’s position in the anti-allergy market with already having US FDA approval for three lead products Loratadine, Desloratadine and Montelukast. It also cements our long-standing relations with our prime customers who have worked with us for two decades and shows their confidence in the company’s product quality and delivery.”

Fexofenadine is the fifth product approved by FDA at Morepen facilities based at Baddi, in the Solan district of Himachal Pradesh, the statement added.