Beximco Pharma is first Bangladeshi company to receive GMP Clearance from TGA Australia

Date: July 22, 2008



Beximco Pharmaceuticals Ltd. (“BPL” or the “Company”), the leading Bangladeshi pharmaceutical manufacturer and exporter, is pleased to announce that it has received approval (GMP Clearance) from Therapeutic Goods Administration (TGA), Australia for its new Oral Solid Dosage (Tablet, Capsule), and the Metered Dose Inhaler and Spray manufacturing facilities. BPL is the first Bangladeshi company to receive this regulatory approval from TGA, Australia through a stringent facility audit process. With an overall pharmaceutical market of around US 10 billion dollars, Australia is one of the richest pharmaceutical markets in the Asia-Pacific region and the 13th largest in the world. Its per capita spending on medicines is equivalent to top ranking European countries. Australia has a highly advanced healthcare system and has a substantial demand for all types of pharmaceuticals.

Australia is also one of the most highly regulated pharmaceutical markets in the world. The Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Ageing, is the regulatory body responsible for conducting assessment and monitoring activities to ensure that therapeutic goods (including medicines, medical devices, gene technology, and blood products) available in Australia are of high standard. Under Mutual Recognition Agreements (MRA), TGA’s Certificates of GMP Compliance are recognized by over 20 developed countries including Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the UK.

Beximco Pharma CEO Mr. Nazmul Hassan said: “In our long history of more than 25 years, Beximco Pharma has always been the leader and the flagship of the Bangladesh pharmaceutical industry by setting new trends and exploring new horizons of export opportunities. In achieving GMP Clearance from a globally recognised regulatory authority like TGA Australia, BPL has crossed a very important milestone in its journey to become a global pharmaceutical company. This TGA approval puts Beximco Pharma in an elite group of manufacturers world-wide who have passed the rigorous quality standards of the Australian government, enabling the Company to manufacture and export medicines to Australia and numerous other countries in the developed world which recognise the standard.”