Beximco’s fifth ANDA approved in USA
Custom Synthesis, Beximco Pharmaceuticals got approval from the US Food and Drug Administration (FDA), for its Nadolol tablets, a generic equivalent of Bristol-Myers Squibb’s Corgard, for hypertension and chest pain, angina pectoris.
Beximco noted that this is its fifth Abbreviated New Drug Application (ANDA) successfully approved for the US market since the its 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 LLC. According to IQVIA market data (MAT March 2018), the estimated market for for Nadolol tablets in the US is currently valued at USD 71 million.
Mr. 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 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.
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