Wockhardt gets DCGI nod for 2 new antibiotics

New Delhi: Drug firm Wockhardt on Thursday said it has received approval from the Indian drug regulator for its two new antibiotics indicated for the treatment of acute bacterial skin and skin structure infections.

The approval by the Drug Controller General of India (DCGI) is for novel antibiotics discovered and manufactured in India by an Indian company, Wockhardt MD Murtaza Khorakiwala said in a media conference call today.

The approval for the two novel antibiotics by the DCGI paves way for a Rs 100 crore opportunity for the company in the country over 18 to 24 months on an annual basis, he added.

The size of Indian antibiotic market is around Rs 16,000 crore, growing at 7 per cent and is one of the largest therapeutic segment, with around 12 per cent market share of the Indian pharmaceutical market, Khorakiwala said.

The company will also launch these antibiotics in emerging markets primarily through partnerships, he added.

"DCGI has approved Wockhardt's 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the phase 3 study involving 500 patients in 40 centres across India," Wockhardt said in a statement.