BEXIMCO PHARMACEUTICALS LTD.

23rd June 2015

Beximco Pharma gets US FDA approval

 

Beximco Pharmaceuticals Limited (“BPL”, “Beximco Pharma” or “Company”) becomes the first Bangladeshi pharmaceutical company to be approved by the U.S. Food and Drug Administration (US FDA) following successful inspection of its oral solid dosage facility at Tongi, during January 19-22, 2015. The company says it has received the establishment inspection report (EIR) from the US drug regulatory authority stating that the audit is formally concluded. This is a major milestone for the company as well as for the entire industry as this is the first time a Bangladeshi company has received the prestigious FDA approval. This approval is based on the comprehensive audit encompassing all the systems of drug manufacturing: Quality; Facilities and Equipment; Materials; Production; Packaging and Labeling; and Laboratory Controls. Remarkably, there was no 483 observation issued by the US regulatory authority. A 483 form is issued when FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP).

The company has already submitted several Abbreviated New Drug Application (ANDAs) for the US market which are currently under review; export to US market will commence as soon as those ANDAs are approved. Nazmul Hassan, Managing Director of Beximco Pharma, said; “This is a remarkable achievement for the Bangladesh pharmaceutical industry as this makes ways for us to export medicines to the US market known for stringent regulations and quality standards.”

Beximco Pharma is a leading exporter of medicines in the country with its facilities already accredited by the regulatory authorities of 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

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; Australia etc.