Last checked at 25 Oct 2016 07:00
25 October 2016
BEXIMCO PHARMACEUTICALS LTD.
Beximco Pharma receives second product approval from the US FDA
Beximco Pharmaceuticals Limited ("BPL" or "the Company"; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, has received US Food and Drug Administration (FDA) approval for Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, following submission of an Abbreviated New Drug Application (ANDA) in June 2014. This is the second product from Beximco Pharma to be approved by the US FDA after Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015.
This approval will allow Beximco Pharma to produce Sotalol tablets in different strengths, i.e. 80 mg, 120 mg and 160 mg. The Company expects to launch this product during the first quarter of 2017.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
"We are delighted to have received our second product approval from the US FDA. Sotalol was fully developed in-house and this approval demonstrates our continued focus on strengthening capabilities, especially our competitive R&D and regulatory skills. We are already exporting Carvedilol to the US and I firmly believe this approval, together with our growing pipeline, will help us to build our presence in the US pharmaceutical market in the coming years."
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015.
Beximco Pharma is the largest exporter of pharmaceuticals in Bangladesh, winning the country's National Export Trophy (Gold) a record five times, the highest national accolade for export. 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:
Beximco Pharma
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
Daniel Stewart & Company plc (Broker)
David Lawman / Daphne Zhang
Tel: 020 7776 6550
FTI Consulting
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 3,000 employees of the Company.
Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of the US, 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.