FDA approves Beximco to manufacture Carvedilol for US

Beximco Pharmaceuticals Limited has become the first Bangladeshi pharmaceutical company to receive approval for a prescription drug to be manufactured in this country for export to the USA. The Company says it has been granted formal approval from the U.S. Food and Drug Administration (U.S. 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 (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg) at the Company′s Tongi facility 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 U.S. 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 in the region of US $ 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, and we believe that this is a significant step forward in the development and execution of the Company’s export strategy.

Nazmul Hassan MP, Managing Director of Beximco Pharma, 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. We are already exporting medicines to Europe and Australia, and we believe, with our interesting range of products, intended for the U.S, we will be able to boost our export sales in the coming years.”

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