FDA approves Beximco to manufacture Carvedilol for US
pharmafile | November 24, 2015 | News story | Manufacturing and Production | Bangladesh, Beximco, Carvediol, FDA, exports, generics
Beximco Pharmaceuticals has become the first Bangladeshi pharma company to receive approval for a prescription drug to be manufactured in Bangladesh for export to the US.
The company was granted formal approval by the FDA to manufacture the blood pressure drug Carvedilol following an extensive review of its submitted dossier and manufacturing processes.
This approval means Beximco, which is based in Dhaka and is the largest private sector group in Bangladesh, can manufacture Carvedilol in different strengths (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg) at the Company’s facility in Tongi. The plant recently achieved GMP approval from the US regulatory authority.
Nazmul Hassan, who is managing director of Beximco Pharma, says: “This is a major milestone for the company, and the whole Bangladeshi 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.”
Beximco is one of the fast-growing manufacturers of generic pharmaceutical products and active pharmaceutical ingredients. It 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 $3-4 million initially.
The Company operates from a 23 acre site in Dhaka and has manufacturing facilities for producing various drugs in different delivery systems. Beximco’s manufacturing facilities are certified by global regulatory authorities of the US, Australia, Europe, Latin America, and Canada, among others. It has already submitted several Abbreviated New Drug Application (ANDAs) for the US market which are currently under review.
Yasmita Kumar
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