Zenotech Laboratories has received marketing and manufacturing approval for GM-CSF (Innovator brand: Leucomax by Novartis) and G-CSF (Neupogen by Amgen/Roche) biotech products. Both the products are used by oncology specialists to treat neutropenia in cancer patients.
The company is launching both the products in India soon. The company claims to be the first Indian company to develop generic version of GM-CSF.
The company's biologics manufacturing facility was inspected by DCGI and by scientists from National Institute of Biologics. The Biologics facility is about 1,00,000 square feet and meets US FDA and EU specifications.
The company is in discussions with potential partners to take its G-CSF to the European Union.