Beximco Pharmaceuticals Limited has received US Food and Drug Administration (FDA) approval for its Nadolol tablets (20mg, 40mg and 80mg), which are generic equivalent of Bristol-Myers Squibb’s Corgard tablets, for treating hypertension (high blood pressure) and angina pectoris (chest pain).
This is Beximco Pharma’s fifth Abbreviated New Drug Application (ANDA) approved for the US market since the company’s oral solid dosage facility was approved by the US FDA in June 2015, said a company press release.
Beximco Pharma expects to launch the product through its US distribution partner, Bayshore Pharmaceuticals LLC. According to IQVIA market data (MAT March 2018), the estimated market for Nadolol tablets in the US is currently valued at USD 71 million.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented: “We are delighted to have received our fifth product approval for the US market. Beximco Pharma remains the only Bangladeshi company to export medicines to the US, which is a validation of our expertise in offering specialised generic products in a global setting. We believe our strategic focus on building presence in key emerging and developed markets will help boost our export in the coming years.”
Beximco Pharma is a leading exporter of pharmaceuticals in Bangladesh. The company currently has a global footprint in more than 50 countries and has been accredited by the leading global regulatory authorities namely US FDA, AGES (EU), TGA (Australia), Health Canada, GCC (Gulf) and TFDA (Taiwan).
BD Post Desk