Eskayef obtains UK MHRA certification
Tuesday, 2 September 2008
Raihan M ChowdhurybrEskayef Bangladesh Ltd, one of the leading pharmaceutical manufacturers and exporters of Bangladesh has obtained accreditation from UK-based Medicines and HealthCare Products Regulatory Agency (MHRA) for its new plant at Tongi.brWe are extremely happy to disclose that Eskayef has obtained the MHRA approval to export tablets, capsules and granules (Pellets) to UK and other European countries, AM Faruque, managing director of Eskayef Bangladesh Limited told the FE.brEskayef became the third company after Square Pharma and Renata Ltd to obtain the MHRA certificates.br This is a milestone for the company which paves way to export Eskayef products to European countries. The opportunity will help enhance contribution to foreign currency earning, AM Faruque added.brHe mentioned UK MHRA approval is one of the toughest registration process for pharmaceuticals in the world which allows pharmaceutical products for marketing and distribution in the UK and other EU countries.brThis approval would also help Eskayef to enter into the highly regulated markets like Australia, South Africa and GCC countries. And we have already started preparation for registration of products in those countries. he added.brMHRA registration is very complex process starting from raw material sourcing to production processes, quality control and quality assurance processes, finally leading to the total quality assurance of the products.brUK MHRA has sent their inspector, who did a thorough inspection of plants, audited the designing lay out of the manufacturing plant, quality of the machineries and the equipments, HVAC (Heating, Ventilation and Air-conditioning) system, purified water system, effluent treatment system, proper validation of the machineries, equipment and materials.brThe inspectors found that Eskayef complies with the Good Manufacturing Practice (GMP) of UK.brEskayef Bangladesh Limited being the successor of the Smith Kline & French, USA (SK&F) maintaining the Standard Operating Procedures of a Multinational company from its inception.br UK MHRA certification is just a beginning of our journey, we are now planning to obtain the US FDA certification and have already started groundwork for that Faruque said.brThe company exported products to around 15 countries of the world across 4 continents. brThe company is expected to export medicines worth Tk 400 million by the end of this year which was only Tk 70 million in the last year.brFaruque believed that the country has the ability to win a greater share of the international drug market due to the low costs of manufacture in Bangladesh. brBangladesh 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.brThe country earned US$32.97 million by exporting pharmaceuticals products to around 67 countries during the first nine months of 2007-08 fiscal, a whopping 60 percent rise over the same period in the previous fiscal.