BEXIMCO PHARMACEUTICALS LTD.
25 July 2017
US FDA approves Beximco Pharma's muscle relaxant Methocarbamol tablets
Fourth product approval for the US market
Beximco Pharmaceuticals Limited ("Beximco Pharma" or "the Company"; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces that it has received approval for its Methocarbamol tablets (500 mg and 750 mg) from the US Food and Drug Administration (US FDA). This product is a generic equivalent to the muscle relaxant Robaxin tablets (500 mg and 750 mg), produced by Auxilium Pharmaceutcials, LLC, for pain relief associated with acute musculoskeletal conditions.
This is Beximco Pharma's fourth 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 during the last quarter of 2017. According to IMS data, the estimated market for Methocarbamol tablets in the US is approximately $30 million.
Mr. Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
"We are delighted to have received our fourth product approval, within two years, from the US FDA. I firmly believe our US product approvals to date, along with our growing pipeline, will help us to continue to build our presence in this important market. We remain focused on our strategic goal to bring high quality, differentiated products to emerging and developed markets to create value for all our customers and shareholders."
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015. The Company currently has a global footprint in more than 50 countries and has been accredited by a number of global regulatory authorities, including US FDA, AGES (EU), TGA Australia, Health Canada, GCC and TFDA.
For further information please visit www.beximcopharma.com or enquire to:
Nazmul Hassan MP, Managing Director
Tel: +880 2 58611001, ext.20080
SPARK Advisory Partners Limited (Nominated Adviser)
Mark Brady / Sean Wyndham-Quin
Tel: +44 (0) 20 3368 3551 / 3555
Simon 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 manufactures 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 3,500 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, 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 the US.