Morepen gets USFDA nod for anti-allergy drug

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

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USFDA
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Last Updated on December 4, 2021 by The Health Master

Morepen Laboratories Limited has received USFDA approval for its anti-allergy drug fexofinadine hydrochloride, which is marketed in India under the popular brand name Allegra, among others, and is the blockbuster 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 the 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 exporter of this drug to the world and will move up 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.

Fexofinadine is among the top five leading products of the company and is the fourth anti-allergy drug in Morepen’s product basket, in addition to Loratadine, Desloratadine and Montelukast.

Morepen holds a leadership position in Loratadine group since last 20 years and was first to file for marketing permissions in USA markets.

Fexofinadine is marketed primarily in two dosage forms: 120mg and 180mg, and is available to buy over the counter in many countries, including the USA, Australia, New Zealand, and certain countries in Europe.

It is also used in combination with other anti-allergy drugs like Montelukast for which Morepen has got the largest manufacturing capacity in the world and is already approved in US market.

Sushil Suri, Chairman and Managing Director, stated, “The approval of anti-allergy drug Fexofinadine (Allegra) by USFDA 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 company’s product quality and delivery”

This approval of Fexofenadine is the 5th product approved by USFDA at Morepen facilities based at Baddi, in the Solan district of State of Himachal Pradesh. The company has got an excellent track record with the USFDA regulators and have never got any major/critical observations during its inspections.

Morepen has a strong portfolio of APIs with a market size of over US $ 42 billion, which is going off patent over the next 7-8 years, and is building additional capacities in a multiphase USFDA expansion as demand for niche molecules and global customers remains stronger than ever. The market size, the company is looking to address is US $ 42 billion compared to US $ 2 billion currently.

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