Beximco Pharma receives US FDA approval

BEXIMCO PHARMACEUTICALS LTD.

24 June, 2015

Beximco Pharma receives US FDA approval

Becomes the first Bangladeshi company to receive US FDA accreditation

Beximco Pharmaceuticals Limited ("BPL", "Beximco Pharma" or "Company"; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces it has become the first Bangladeshi pharmaceutical company to be approved by the US Food and Drug Administration (US FDA) following the successful inspection of its oral solid dosage facility at Tongi, during 19-22 January, 2015. The Company received the establishment inspection report (EIR) from the US FDA on 22 June, 2015 stating the audit was formally concluded. 

This approval is based on the comprehensive audit of all the systems of drug manufacturing, which include quality; facilities and equipment; materials; production; packaging and labeling; and laboratory controls. Throughout the inspection there was no 483 observation issued by the US FDA. A 483 form is issued when the US FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP).

Beximco Pharma has already submitted several Abbreviated New Drug Applications (ANDAs) to the US FDA, which are currently under review. Export to the US market is expected to commence following the approval of these ANDAs.

Nazmul Hassan, Managing Director of Beximco Pharma, said; "This US FDA approval is a major milestone for Beximco Pharma. We have become the first Bangladeshi company to receive US FDA accreditation, which is a remarkable achievement for the Company and the whole Bangladesh pharmaceutical industry. It paves the way for the export of medicines to the US market, which is known for its stringent regulations and high quality standards."

Beximco Pharma is a leading manufacturer and exporter of medicines in Bangladesh and its facilities are already accredited by the regulatory authorities of the European Union, Australia, Canada, Taiwan and Brazil, among others.

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)

Martin Lampshire

Tel: +44 (0)20 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, 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 South Africa, Mauritius, Kenya, Ghana, Ethiopia and Nigeria; Pacific Island; 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 and Australia.