Morepen Laboratories said it expects its US export business to get a major boost now that the US FDA has given it the go-ahead to export allergy drug Allegra to that market.
Fexofinadine, invented by Sanofi Aventis, is the most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever, with a market size of around 700 metric ton.
“The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches,” Morepen Labs said. “Fexofinadine is a very established anti-allergy drug and is expected to give immediate impetus to company’s export business.”
Morepen is the third largest exporter of this drug to the world and is likely to move up in the ranks after this approval.
The company said it 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 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,” it said.
Fexofinadine is marketed primarily in two dosage forms 120mg and 180mg and is available to buy over the counter in many countries including USA, Australia, New Zealand, and certain countries around 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.
Morepen said the latest approval consolidates the company’s position in the anti-allergy market, having already got USFDA approval for Loratadine, Desloratadine and Montelukast, all of which are also used to mitigate allergies.
“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,” the company claimed.
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 claims that it has never got any major/critical observations during USFDA inspections at the plant.
Morepen also holds a leadership position in Loratadine group for 20 years and was first to file for marketing permission for the drug in the US market.
Morepen Labs focuses on drug ingredients, devices and OTC products in India.
The ingredients or APIs that it manufacturers will soon have a market size of over US$ 42 billion — up from around $2 billion at present — as several drugs go off patent over next 7-8 years, Morepen Labs said.
The company said it is building additional capacities in phases. It also said demand for niche molecules and global customers remain stronger than ever.
Morepen Laboratories has its manufacturing facilities in the state of Himachal Pradesh, including API facilities at Masulkhana and Baddi.