Beximco Pharmaceuticals Limited (“BPL” or “the Company”; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, has received US Food and Drug Administration (FDA) approval for Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, following submission of an Abbreviated New Drug Application (ANDA) in June 2014. This is the second product from Beximco Pharma to be approved by the US 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, i.e. 80 mg, 120 mg and 160 mg. The Company expects to launch this product during the first quarter of 2017.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
“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.”
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015.
Beximco Pharma is the largest exporter of pharmaceuticals in Bangladesh, winning the country’s National Export Trophy (Gold) a record five times, the highest national accolade for export. 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.