IBPL receives EU-GMP certification

Ahmedabad, June 12, 2007 (UNI) Pharma major Intas Bio-pharmaceuticals Limited (IBPL) has become India 's first dedicated bio-pharmaceutical company to receive certification of European Agency for the Evaluation of Medicinal Products (EMEA) or a EU-GMP certification for its manufacturing facility here.

The certification is a significant step towards fulfilment of IBPL's plans to tap Europe market. Moreover, the certification gives strong advantage to IBPL as the company can strengthen existing alliances and look forward to possible agreements with other pharma/biotech companies in new geographical regions of Europe, said Mani Iyer, Director of IBPL here today while talking to mediapersons. Mr Iyer said ''On the research and development (R&D) front, the certification will allow IBPL to get an entry into regulated markets of Europe to conduct clinical trials for many of our products which are in the pipeline.'' He said the process of clinical trials is mandatory and a pre-requisite for the company to develop the products and market them in Europe. Additionally, this certification has opened new avenues for the company to explore existing/new technologies and processes.

For IBPL, EU-GMP certification will also simplify the procedure for product registration in different countries of the world by significantly reducing the time required by the company to get the product registration. Also, many companies across the globe would be keen to associate with us for our products and services, Mr Iyer said.

The company has successfully launched therapeutic recombinant proteins Neukine (rHu G-CSF), Erykine&Epofit (rHu EPO) and Intalfa (rHu IFN Alfa-2b) in the domestic market and couple of international markets. It is the only company in Gujarat with an impressive track record of launching three indigenously developed biotech products in as many years.

On the domestic front, IBPL will have strong advantage as the certification is indicative of superior quality standards in line with international guidelines and procedures. IBPL will find itself in the best position to plan certain key initiatives in the coming financial year, Mr Iyer added.

Starting with bio-generics, IBPL has structured its progression to the development of proprietary and innovative recombinant biopharmaceuticals. It has also entered into several distribution and marketing agreements with reputed international companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia&CIS, South and Central America and Africa.

UNI