The company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May 2025.
Filing to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory filing.
The company plans for regulatory approval for the product in Europe and emerging markets in the second half of the current financial year, it added.
Wockhardt said it has also filed for approval of Zaynich with the Drug Controller General of India (DCGI) and expects to launch the product in the domestic market in the second half of the current fiscal.
The antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, the Mumbai-based drug maker said. In May, the drug firm reported a narrowing of consolidated net loss at Rs 45 crore in the fourth quarter ended March 31, 2025. The company had reported a net loss of Rs 177 crore in the January-March quarter of FY24.
Revenue from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago period.
For FY25, the company said its net loss stood at Rs 57 crore against Rs 472 crore in the year-ago period.
Revenue increased to Rs 3,012 crore from Rs 2,798 crore in the 2023-24 fiscal.
Shares of Wockhardt Ltd on Thursday ended 2.42 per cent higher at Rs 1,528.60 apiece on the BSE.
