Last checked at 19 Nov 2015 07:00
BEXIMCO PHARMACEUTICALS LTD.
19 November, 2015
Beximco Pharma receives US FDA approval to manufacture blood pressure drug Carvedilol
Beximco Pharmaceuticals Limited ("BPL", "Beximco Pharma" or "Company"), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces it has become the first Bangladeshi pharmaceutical company to receive approval for a prescription drug to be manufactured in Bangladesh for export to the US.
The Company was granted formal approval by the US Food and Drug Administration ("US FDA") following an extensive review of the submitted dossier and its manufacturing processes. This approval allows the Company to manufacture a popular blood pressure drug, Carvedilol, in different strengths (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg) at the Company's Tongi facility, which recently achieved GMP approval from the US regulatory authority. The Company expects to commence export of Carvedilol in the first half of 2016. The full year export revenue from this product is projected to be in the region of US $3-4 million, initially.
Nazmul Hassan MP, Managing Director of Beximco Pharma, said:
"This is a major milestone for the Company, and the whole Bangladesh pharmaceutical industry, as it is the first time the US FDA has approved a prescription drug to be manufactured in Bangladesh for supply into the US market. We are increasingly focused on building our presence in the US generics market and this approval marks the beginning of a new era for the Company. We are already exporting medicines to Europe and Australia, and with our interesting range of products intended for the US, we believe we will be able to boost our export sales in the coming years."
For further information please visit www.beximcopharma.com or enquire to:
Beximco PharmaNazmul Hassan MP, Managing DirectorTel: +880 2 58611001, ext.20080
SPARK Advisory Partners Limited (Nominated Adviser)Mark Brady / Sean Wyndham-QuinTel: +44 (0)20 3368 3551 / 3555
FTI ConsultingSimon Conway / Victoria Foster MitchellTel: +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, nebulizer 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, Australia, Europe, Latin America, and Canada, 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 Africa, including South Africa, Mauritius, Kenya, Ghana, Ethiopia and Nigeria; Pacific Islands; Latin and Central American countries; Middle East; Central Asia; South East Asia, including Singapore, Malaysia, Indonesia, Philippines and Hong Kong; Europe, including Austria, Germany and Romania; Australia etc.