Renata Limited, the second pharmaceutical company in Bangladesh to win approval to manufacture drugs for the European market, is poised to send its first consignment to the UK.
The country's seventh largest pharmaceutical group in terms of sales, has won an order to supply a UK drug company with Prednisolone, a generic steroid product.
The deal marks another significant step in the attempts by Bangladesh's pharmaceutical industry to expand its export markets and become a serious player in the global pharmaceutical business.
The consignment has already been produced at the Renata's facility in Mirpur and is now waiting for the final approvals before it can be shipped.
“We are ready to ship the first consignment of drug anytime to Europe as soon as we get the green signal from the UK company,” Syed S. Kaiser Kabir, Chief Executive Officer and Managing Director of Renata Limited.
Gaining access to the European market is a long and difficult process and took Renata around four year. Before any drugs can be sold authorities from the importing country must meticulously inspect production facilities.
Last year Renata's newly built US$3 million Potent Product Facility was approved by the UK's Medicines and Healthcare products Regulatory Agency.
The approval was for Prednisolone tablets and the company is now seeking MHRA approval for other classes of drugs including oncology medicines and immunosuppressants in order to supply these to European markets.
Prednisolone is used to treat different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
Renata is the second pharmaceutical company after Square Pharmaceuticals to gain MHRA approval. Square has already shipped products to the UK, and hopes to gain further orders in the lucrative European market through contract manufacturing of bulk drugs and formulations.
Several other groups are in the process of seeking MHRA approval.
Industry leaders belief the country has the ability to win a greater share of the international drug market due to the low costs of manufacture in Bangladesh. Mainly this is due to the relatively low cost of labour, especially skilled white-collar staff.
Bangladesh also has opportunities under the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights that give the country the strong rights to manufacture generic drugs that it can export to other less developed countries.
So far however the process has been slow, due to the extreme difficulty in gaining approvals from foreign regulatory bodies, especially to the major markets of Europe and North America.
The country earned US$32.97 by exporting pharmaceuticals products to around 67 countries during the first nine months of the current 2007-08 fiscal up 60 percent over the same period in the previous fiscal.
Renata Limited earned 33.60 crore net profit after tax in the year 2007 ended December 2007 against the profit of Tk 24.21 crore in 2006.
Earning per share of the company rose to Tk 348.47 each in the year 2007 against the previous year's Tk 251.18 against the value of each share Tk 100.
The company was founded in 1972 as a subsidiary of Pfizer Inc and the ownership transferred from Pfizer Inc. to local institutions and the general public in 1993.