BEXIMCO PHARMACEUTICALS LTD.
21 September 2020
Beximco Pharma receives US FDA approval for antiarryhtmic drug Flecainide
Marks the Company's eighth product approval for the US market
Beximco Pharmaceuticals Limited ("Beximco Pharma", "BPL" or "the Company"; AIM Symbol: BXP, LEI No.: 213800IMBBD6TIOQGB56), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces it has received US Food and Drug Administration (FDA) approval for Flecainide Acetate (50, 100 and 150 mg tablets), an antiarrythmic drug used for treating irregular heartbeats in conditions such as tachycardia and artrial fibrillation.
This is Beximco Pharma’s eighth 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. The Company expects to launch the product through its US distribution partner in due course.
Flecainide Acetate is the generic equivalent to 3M Pharmaceuticals’ Tambocor® (50, 100 and 150 mg tablets). According to IQVIA audited market data, the total addressable market for Flecainide Acetate is approximately US$50 million (Moving Annual Total, June 2020).Mr. Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
"This approval is another important step in building and strengthening our presence in the US market. We continue to leverage our core strengths in R&D and manufacturing to develop and deliver specialised generic products, not only in the US, but also in a global setting.”
The information communicated in this announcement contains inside information for the purposes of Article 7 of Regulation 596/2014.
S M Rabbur Reza, Chief Operating Officer
For further information please visit www.beximcopharma.com or enquire to:
Nazmul Hassan MP, Managing Director
Tel: +880 2 58611001, ext.20080
Tel: +880 2 58611001, ext. 20111
SPARK Advisory Partners Limited (Nominated Adviser)
Mark Brady / Andrew Emmott
Tel: +44 (0)20 3368 3551 / 3555
SP Angel Corporate Finance LLP (Broker)
Vadim Alexandre / Abigail Wayne
Tel: +44 (0) 20 3470 0470
Simon Conway / Victoria Foster Mitchell
Tel: +44 (0)20 3727 1000
Notes to Editors:
About Beximco Pharmaceuticals Limited
Beximco Pharma is a leading manufacturer and exporter of medicines based in Bangladesh. Since its inception in 1976, the Company remains committed to health and wellbeing of people across all the continents by providing access to contemporary medicines. Company’s broad portfolio of generics encompasses diverse delivery systems such as tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, insulins, prefilled syringes, injectables, nebuliser solutions, oral soluble films etc. The Company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies.
Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of USA, Europe, Australia, Canada, GCC and Brazil, among others and it has a geographic footprint in more than 50 countries. More than 4,200 employees are driving the company towards achieving its aspiration to be among the most admired companies in the world.