BEXIMCO PHARMACEUTICALS LTD.

02nd February 2015

Beximco Pharma completes US FDA Audit

 

Beximco Pharmaceuticals Limited ("BPL" or "Company"; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces that it has become the first Bangladeshi pharmaceutical company to be audited by the US Food and Drug Administration (“FDA”) without any 483 observation. A 483 form is issued when the US FDA has observations of non-compliance or deviation from its current Good Manufacturing Practices (“cGMP”). The inspection of Beximco Pharma’s oral solid dosage manufacturing facility, in Tongi, took place during 19-22 January, 2015.

Nazmul Hassan, Managing Director of Beximco Pharma, said; “The US FDA is a globally regarded regulatory authority, known for its stringent regulatory standards. We are pleased with the US FDA inspection of our manufacturing facility in Tongi and we would like to thank our employees for their hard work in achieving this milestone.  In addition, this marks the first time the US FDA has conducted an audit of a pharmaceutical facility in Bangladesh.”

 Beximco Pharma is a leading manufacturer and exporter of medicines in Bangladesh and its facilities are already accredited by the regulatory authorities of Australia, Europe, Latin America and Canada, among others.

 

For further information please visit www.beximco-pharma.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

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, 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 Australia, Europe, Latin America, Canada and the US, 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 Mauritius, Kenya, Ghana and Nigeria, Pacific Island, Latin and Central American countries, Middle East, Central Asia, South East Asia, including Singapore, Malaysia, Philippines and Hong Kong, and Europe, Austria and Australia.