Beximco set to export cardiovascular drug to US

Beximco Pharmaceuticals' plan to expand its footprint into the US, one of the highly regulated drug markets in the world, became one step closer to reality after the Food and Drug Administration gave it a go-ahead to sell cardiovascular medicine.

The local drug manufacturer is now expecting to launch Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, in the US market by the first quarter of 2017.

Beximco will produce and sell Sotalol tablets in the US market of three different strengths: 80mg, 120mg and 160mg.

This is the second product from Beximco approved by the FDA after Carvedilol, a prescription drug for treating hypertension, introduced in the American market in August.

“We are delighted to have received our second product approval from the US FDA,” said Nazmul Hassan, managing director of Beximco Pharmaceuticals.

Sotalol was fully developed in-house and the FDA approval demonstrates Beximco's continued focus on strengthening capabilities, especially their competitive research and development and regulatory skills.

“We are already exporting Carvedilol to the US and I firmly believe this approval, together with our growing pipeline, will help us to build our presence in the US pharmaceutical market in the coming years,” said Hassan, also a lawmaker.

Beximco Pharmaceuticals, an entity of business conglomerate Beximco Group, first received the permission from the FDA to export medicines to the American market in November last year. It has been also accredited by a number of global regulatory authorities including AGES (EU), TGA Australia, Health Canada, GCC and TFDA.

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 Pharmaceuticals traded between Tk 75.9 and Tk 77, before closing at Tk 76.7 on the Dhaka Stock Exchange yesterday.

Sponsors hold a 13.18 percent stake in Beximco Pharmaceuticals, institutions 28.45 percent, foreign investors 37.11 percent and general investors the rest 24.26 percent, according to the DSE data.