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Regulatory Bodies & Rulings
Zenotech gets nod for biotech products
Our Bureau
Hyderabad, Aug. 8
Zenotech Laboratories Ltd (ZLL) has announced that it has received marketing and manufacturing approval for two of its biotech products GM-CSF (Innovator brand: Leucomax by Novartis) and G-CSF (Neupogen by Amgen/Roche). In a press release here on Tuesday, the company said both the products are used by the oncology specialists to treat neutropenia in cancer patients. The company said it would be launching both the products in India in the next few days. Zenotech said it is the first Indian company to develop generic version of GM-CSF.
According to the release, Zenotech's biologics manufacturing facility was inspected by the Drug Controller General of India (DCGI) and by scientists from National Institute of Biologicals. The biologics facility is about 1-lakh square feet and meets US FDA and EU specifications. Further, the company said it is currently in discussions with potential partners to take its G-CSF to the European Union.
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