US FDA Approves Beximco Pharma's Nadolol Tablets

30 July 2018

BEXIMCO PHARMACEUTICALS LTD.

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 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).

For further information please visit www.beximcopharma.com or enquire to:Beximco PharmaNazmul Hassan MP, Managing Director Tel: +880 2 58611001, ext.20080

Md. Asad Ullah, FCS, Executive Director & Company Secretary

Tel: +880 2 58611891, +880 2 58612040, Ext 10140

SPARK Advisory Partners Limited (Nominated Adviser)Mark Brady / Andrew EmmottTel: +44 (0)20 3368 3551 / 3555

Northland Capital Partners Limited (Broker)

Tom Price

Tel: +44 (0)20 3861 6625

FTI ConsultingSimon Conway / Victoria Foster Mitchell Tel: +44 (0)20 3727 1000

Notes to Editors: 

About Beximco Pharmaceuticals Limited

Founded in 1976 and based in Dhaka, Bangladesh, Beximco Pharma manuactures and sells generic pharmaceutical formulation products and active pharmaceutical ingredients. The Company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies. The Company operates from a 23-acre site in Dhaka and has manufacturing facilities for producing various drugs in different delivery systems such as tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, prefilled syringes, injectables, nebuliser solutions, oral soluble films etc. Ensuring access to quality medicines is the powerful aspiration that motivates 3,800 employees of the Company.

Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of USA, Europe, Australia, Canada, GCC and Latin America, among others. The Company's products are sold to retail outlets, medical institutions and other pharmaceutical manufacturers in Bangladesh, in regional markets such as Sri Lanka, Nepal, Bhutan, Vietnam, Cambodia and Myanmar and in other markets overseas, principally in South East Asia, including Singapore, Thailand, Taiwan, Malaysia, Indonesia, Philippines and Hong Kong; Africa, including South Africa, Mauritius, Kenya, Ghana, Ethiopia, Uganda and Nigeria; Central Asia, including Azerbaijan; Middle East, including Kuwait and Jordan; Pacific Island countries; Latin and Central American countries; Europe, including Austria, Germany and Romania; Australia and North America, including the USA and Canada.