US FDA approves Beximco pharma Nadolol tablet

US FDA approves tablet to treat high blood pressure and angina from the generic pharmaceutical manufacturer, based in Bangladesh

Beximco Pharmaceuticals, a manufacturer of generic pharmaceutical products and APIs, has announced that it has received approval for its Nadolol tablets (20 mg, 40 mg and 80mg) from the US Food and Drug Administration (FDA).

This product is a generic equivalent of Bristol-Myers Squibb's Corgard and is used in the management of hypertension and angina pectoris.

This is Beximco Pharma’s fifth abbreviated new drug application (ANDA) successfully approved for the US market since the company's oral solid dosage facility was approved by the US FDA in June 2015.

Beximco Pharma expects to launch the product through its US distribution partner, Bayshore Pharmaceuticals. According to IQVIA market data (MAT March 2018), the estimated market for for Nadolol tablets in the US is currently valued at US$71 million.

Nazmul Hassan MP, MD, Beximco Pharmaceuticals, said: “We are delighted to have received our fifth product approval for the US market. Beximco Pharma remains the only Bangladeshi company to export pharmaceutical products to the US, which is a validation of our expertise in offering specialised generic products in a global setting. We believe our strategic focus to continue building Beximco Pharma’s presence in key global markets will help boost our export sales in the coming years.”

In August 2016, Beximco Pharma became the first Bangladeshi pharmaceutical company to export medicine to the US market following the approval of its manufacturing site by the FDA in June 2015.

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