Beximco Pharma gets all-clear from FDA to sell another drug in US market

Bangladesh's Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to launch Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, in the market.

The company released a statement on Monday saying that this is the second product from Beximco Pharma to be approved by the FDA after Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015. 

This approval will allow Beximco Pharma to produce Sotalol tablets in different strengths like 80 mg, 120 mg and 160 mg.

The company expects to launch this product during the first quarter of 2017.

In the media release, Nazmul Hassan, Managing Director of Beximco Pharmaceuticals, said, "We are delighted to have received our second product approval from the US FDA."

"Sotalol was fully developed in-house and this approval demonstrates our continued focus on strengthening capabilities, especially our competitive R&D 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,” he added, according to the release.

Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015, the release said. 

It is the largest exporter of pharmaceuticals in Bangladesh, winning the country’s National Export Trophy (Gold) a record five times.

The company currently has a global footprint in more than 50 countries and has been accredited by a number of global regulatory authorities, including US FDA, AGES (EU), TGA Australia, Health Canada, GCC and TFDA, according to the release.