On Friday, Indian pharmaceutical company Morepen Laboratories said it has received approval from the Food and Drug Administration (FDA) to market Fexopen (generic fexofenadine) in the U.S. market.
Fexopen is the generic version of Sanofi Aventis’ anti-allergy drug Allegra. Fexofenadine is a commonly used second-generation antihistamine for the treatment of allergy and hay fever.
Morepen said in a statement, “The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches. Fexofenadine is a very established anti-allergy drug and is expected to give immediate impetus to the company’s export business.”
The company also said it has teamed up with regular supplies of fexofenadine 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,” it added. “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.”
Sushil Suri, Chairman and Managing Director of Morepen, said, “Approval of anti-allergy drug fexofenadine by 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 USFDA approval for three lead products loratadine, desloratadine and montelukast.”
The company said, “Morepen has a strong portfolio of APIs (Active Pharmaceutical Ingredient) with market size of over USD 42 billion, which is going off-patent over next 7-8 years and is building additional capacities in a multiphase FDA expansion as demand for niche molecules and global customers remain stronger than ever.”
“The drug firm is looking to address $42 billion markets in the future as compared to USD 2 billion currently,” it added.
Fexofenadine is available in two dosages – 120 mg and 180 mg. One can buy generic fexofenadine over the counter in many countries, including the U.S., Australia, New Zealand, and certain European countries.
A combination of fexofenadine and other anti-allergy drugs, like montelukast, is used for the treatment of allergies.
Morepen said it is building additional capacities in phases. The company has its manufacturing facilities in the state of Himachal Pradesh, India.
