Morepen Laboratories Limited rose as much as 5% to a day high of Rs 99.15 on 9 November after its first US prescription generic launch.
The news came before the market opened. In a filing, Morepen said it has launched Desloratadine Tablets USP 5 mg, an allergy medicine, in packs of 100 and 500 tablets.
It will sell the product through Morepen Bio Inc, its wholly owned US arm.
For several years, the company has supplied the key ingredient for this medicine to US customers.
The new launch lets the pharma firm sell the finished tablet itself.
Managing Director Sanjay Suri said Morepen’s long-standing ties with ingredient buyers in regulated markets give it a base to grow from.
He added that the company is selectively moving into finished medicines and US distribution, beyond its contract development and manufacturing work.
This is not Morepen’s first step into the US consumer market. It had earlier launched over-the-counter products there, which are medicines sold without a prescription. There is a second item in the pipeline.
Morepen submitted its first ANDA for Sitagliptin Phosphate Tablets USP, a diabetes drug, in 25 mg, 50 mg and 100 mg strengths, and the filing says the regulator’s review is under way.
An ANDA is the route a company takes to get US approval for a generic version of an existing medicine.
Morepen plans more US prescription generic filings and distribution deals.
It may also look at high-potency ingredients and cancer medicines, depending on feasibility, regulatory needs and market conditions.
On 27 October, Morepen reported a 117% year-on-year rise in second-quarter consolidated net profit to Rs 89 crore, on revenue growth of 81%.
At 10:55 am, Morepen shares are trading at Rs 98.05 on NSE, up by 3.83% from the previous close of Rs 94.43.
The stock has gained 140.09% so far this year, though it has lost 23.81% over the past month.
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