Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India's first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.
Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India’s first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.
The certification is a significant step towards fulfillment of IBPL’s plans to tap the European market. Moreover, the certification gives strong advantage to IBPL as the company can strengthen existing alliances and look forward to possible agreements with other pharmaceuticals and biotech companies in new geographical regions of Europe.
For IBPL, the 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 obtain the registration. The company has already launched therapeutic recombinant proteins Neukine (rHu G-CSF), Erykine and Epofit (rHu EPO), and Intalfa (rHu IFN Alfa-2b) in the domestic market and a few international markets. It has also launched three indigenously developed biotech products in this period.