New Delhi: Morepen Laboratories said the US health regulator has given approval to Montelukast Sodium, used in managing asthma symptoms and seasonal allergies, for sale in the US market.
“The US Food and Drug Administration (USFDA) has cleared Montelukast Sodium, a bulk drug/API manufactured by Morepen Laboratories, for sale in the US market,” the company said in a regulatory filing.
“This gives Morepen an entry into the Rs 2,000 crore (approximately USD 300 million) US market for Montelukast. The first commercial orders for the bulk drug are expected in the second quarter of the next financial year,” it added.
Morepen said patent for Montelukast has expired in all markets worldwide.
Morepen is the market leader for Montelukast in India with over 50 percent market share, supplying to almost all major finished dosage manufacturers in India, it added.