Beximco becomes first Bangladeshi company to receive an FDA approval

Beximco has become the first Bangladeshi company to receive US Food and Drug Administration approval for a prescription drug manufactured in the country for export to the USA.

It was granted formal approval by the FDA following extensive review of the dossier and manufacturing processes for its blood pressure drug carvedilol. Beximco will manufacture the drug in four different strengths at its facility in Tongi, Bangladesh, which recently achieved GMP approval from the FDA. Carvedilol will be exported from the first half of 2016.

Nazmul Hassan, managing director of Beximco, said: “This is a major milestone for the company, and the whole Bangladesh pharmaceutical industry, as it is the first time the US FDA has approved a prescription drug to be manufactured in Bangladesh for supply into the US market.  We are increasingly focused on building our presence in the US generics market and this approval marks the beginning of a new era for the company. We are already exporting medicines to Europe and Australia, and with our interesting range of products intended for the US, we believe we will be able to boost our export sales in the coming years.”