NEW DELHI: Mumbai-based Wockhardt has become the first Indian drug company to get the Drug Control General of India's nod for two novel antibiotics. The company plans to launch them in the next few months in the Indian market.
The new antibiotics Emrok (injectible) and Emrok O (oral), are used for acute bacterial skin and skin structure infections, including diabetic foot infections. The drugs approval is based on a phase 3 clinical study involving 500 patients in 40 centres across the country.
There has been no new antibiotic launch in India in the past 15 years in this category.
Wockhardt plans to take these drugs to emerging markets and China soon. It expects to build them into Rs 100-crore brands over the next 18-24 months.
The new drugs will target superbugs, which have become resistant to other molecules.
Wockhardt Managing Director Murtaza Khorakiwala said, "Wockhardt becomes the first domestic drug maker to get approval for novel antibiotic drugs discovered, developed and manufactured in India."