Beximco Pharmaceu-ticals is expanding its footprint into the US, one of the highly regulated drug markets in the world, as it has recently received approval from the US Food and Drug Administration or FDA to sell a type 2 diabetes medicine.
The local drug manufacturer is now set to launch Metformin Hydrochloride extended-release tablets in two strengths -- 500mg and 750mg -- in the US market in the middle of next year, Beximco said in a statement.
This is the third product from Beximco approved by the FDA. Beximco first introduced Carvedilol, a prescription drug for treating hypertension, in the American market in August.
Sotalol Hydrochloride, a generic version of cardiovascular drug Betapace, is the second product of Beximco that is likely to be introduced in the US market by the first quarter of 2017.
Metformin Hydrochloride tablets are generic equivalent of Bristol-Myers Squibb's Glucophage XR tablets in 500mg and 750mg strengths.
Metformin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Annual sales for Glucophage XR in the US were $918 million for the 12 months to October 2016, Beximco said, citing data from the Intercontinental Marketing Services.
“We are glad to receive our third product approval for the US market and this clearly demonstrates our competitive in-house capabilities, especially our strengths in extended-release formulation,” said Nazmul Hassan, managing director of Beximco Pharma.
Beximco Pharma, a unit of Beximco Group, first received the permission from the FDA to export medicines to the American market in November last year.
Beximco is one of the largest exporters of pharmaceuticals, with footprints in more than 50 countries. It exported medicines worth $15 million in fiscal 2015-16.
Its net profit rose to Tk 195.42 crore at the end of 2015 from Tk 152.83 crore a year earlier.
Listed on the stockmarket in 1986, each share of Beximco Pharma traded between Tk 81.3 and Tk 80, before closing at Tk 80.8 on the Dhaka Stock Exchange yesterday.
Sponsors hold a 13.18 percent stake in Beximco Pharmaceuticals, institutions 27.94 percent, foreign investors 37.84 percent and general investors the rest 21.04 percent, according to the DSE data.