Mumbai-based Wockhardt has become the first Indian pharmaceutical company to get the drug regulator's nod for two novel antibiotics, which it plans to launch in the next few months in the domestic market.
The Drug Controller General of India (DCGI) has approved Emrok (injectable) and Emrok O (oral), used for acute bacterial skin and skin structure infections, including diabetic foot infections. The approval is based on a phase 3 clinical study involving 500 patients in 40 centres across India.
While multinational companies have launched new antibiotics in India, there have been no new launches in the past 15 years in