It said the company has been granted formal approval from the US Food and Drug Administration (US FDA), following an extensive review of the submitted dossier and its manufacturing processes.
This approval allows the company to manufacture a popular blood pressure drug ‘Carvedilol’ in different strengths at its Tongi plant which recently achieved GMP approval from the US regulatory authority.
This is a major milestone for the company as well as for the industry, as this is the first time the US FDA has approved a medicine to be manufactured in Bangladesh for supply into the US market.
The company expects to commence export of Carvedilol in the first half of 2016.The full-year export revenue from this product is projected to be $3-$4 million initially.
Beximco Pharma is a leading exporter of medicines in the country with its facilities already accredited by the regulatory authorities of USA, European Union, Australia, Canada, and Brazil, among others.
Managing Director of Beximco Pharma Nazmul Hassan said: “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 Bangladesh pharmaceutical industry.”
Source: http://www.dhakatribune.com/