Intas Biopharmaceuticals Limited (IBPL) has achieved a unique distinction to become India's first dedicated biopharmaceutical company to receive certification of European Agency for the Evaluation of Medicinal Products (EMEA) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.
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 and biotech companies in new geographical regions of Europe.
Addressing to the media, Shri Mani Iyer, director, IBPL, 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. 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."
The company has successfully launched therapeutic recombinant proteins Neukine (rHu G-CSF), Erykine and Epofit (rHu EPO) and Intalfa (rHu IFN Alfa-2b) in the domestic market and couple of international markets. It is the only company in the state of Gujarat with an impressive track record of launching three indigenously developed biotech products in as many years.
Elaborating on the company's marketing plans, R Chandrashekhar, senior vice president (global marketing and business development), IBPL, said, "With new products in the pipeline and planned efforts to launch these products on domestic and international front, the certification will give IBPL a significant boost to our efforts in registering and commercialising our products in many regulated markets.
Starting with bio-generics, IBPL has structured its progression to the development of proprietary and innovative recombinant biopharmaceuticals. IBPL 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 and CIS, South and Central America and Africa. 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."