FDA approval for muscle relaxant drug Baclofen

26 July 2021

BEXIMCO PHARMACEUTICALS LTD.

Beximco Pharma receives US FDA approval for muscle relaxant drug Baclofen

Continued successful expansion of the Company's product portfolio for the US market

Beximco Pharmaceuticals Limited ("Beximco Pharma", "BPL" or "the Company), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, announces it has received US Food and Drug Administration (FDA) approval for Baclofen (10 and 20 mg tablets), a muscle relaxant drug indicated for the treatment of muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.

This is Beximco Pharma's ninth Abbreviated New Drug Application (ANDA) fully developed in-house and 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.

According to IQVIA audited market data, there are currently nine active players for Baclofen in the US market, which generated sales of more than US$ 110 million in 2020.

Mr. Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:"We are pleased to have received FDA approval of Baclofen, a commonly prescribed medicine in the US, as we continue to leverage our core strengths in R&D and manufacturing to develop and deliver important generic products to patients. This approval strengthens our product offering in the US and we look forward to the launch of generic Baclofen in due course."

For further information please visit www.beximcopharma.com or enquire to: 

Beximco Pharma

Nazmul Hassan MP, Managing Director

Tel: +880 2 58611001, ext.20080

S M Rabbur Reza, Chief Operating Officer

Tel: +880 2 58611001, ext. 20111

Mohammad Ali Nawaz, Chief Financial Officer

Tel: +880 2 58611001, ext.20030

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

FTI Consulting

Simon Conway / Victoria Foster Mitchell / Sam Purewal

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, Brazil and GCC, among others and it has a geographic footprint in more than 60 countries. More than 5,500 employees are driving the company towards achieving its aspiration to be among the most admired companies in the world.