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Pin to quick picksBeximco Pharma Regulatory News (BXP)

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Re: Approval

22 Jul 2008 07:00

RNS Number : 5532Z
Beximco Pharmaceuticals Ltd
22 July 2008
 



22 July 2008

BEXIMCO PHARMACEUTICALS LTD.

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

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 dollarsAustralia 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 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." 

For further enquiries please contact:

 

Beximco Pharma

Nazmul Hassan, CEO

Tel: +880 2 861 9151, ext.2080

 

Libertas Capital

Aamir Quraishi / Andrew Hardy

Tel: +44 (0)20 7569 9650

 

Financial Dynamics

David Yates / Susan Quigley

Tel: +44 (0)20 7269 7169

 

Notes to Editors

About Beximco Pharmaceuticals Limited

Founded in 1976 and based in DhakaBangladesh, BPL manufactures and sells generic pharmaceutical formulation products, active pharmaceutical ingredients and intravenous fluids. The Company also manufactures and markets its own branded generics for almost all diseases. The Company also undertakes contract manufacturing for multinational pharmaceutical companies. The Company operates from a 20 acre site in Dhaka and currently employs over 2,400 staff.

The Company's products are sold to retail outlets, medical institutions and other pharmaceutical manufacturers in Bangladesh, in regional markets such as Sri LankaNepalBhutanVietnamCambodia and Myanmar and in other markets overseas, principally in East Africa, Pacific Island and Central American countries and South East Asia, including Singapore and Hong Kong.

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
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