US FDA approves Beximco Pharma’s Nadolol tablets to treat high blood pressure and angina

Mon, Jul 30, 2018

US FDA approves Beximco Pharma’s Nadolol tablets to treat high blood pressure and angina

Marks the Company’s fifth product approval for the US market

Beximco Pharmaceuticals Limited (“BPL”, "Beximco Pharma" or "Company"; AIM Symbol: BXP, LEI No 213800IMBBD6TIOQGB56), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces that it has received approval for its Nadolol tablets (20mg, 40mg 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 (high blood pressure) and angina pectoris (chest pain).

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 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.

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.”

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.

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).




Source: https://beximcopharma.com/media-gallery/beximco-news/latest-news/item/us-fda-approves-beximco-pharma-s-nadolol-tablets-to-treat-high-blood-pressure-and-angina.html

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