Wockhardt Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich. This marks the first time an NDA for a new chemical entity (NCE) from an Indian pharmaceutical company has been accepted by the FDA—a milestone for both Wockhardt and India’s pharma sector.

Zaynich, developed to treat serious, drug-resistant Gram-negative infections, has previously completed global Phase III trials and earned Fast Track designation from the FDA, underlining its potential to address urgent and unmet medical needs. Wockhardt had filed the NDA on September 30, 2025.

The company says this acceptance reflects its scientific depth and global-standard development credentials. The news triggered a surge in investor interest — Wockhardt’s shares rose sharply following the announcement. Wockhardt aims for a launch by mid-2026, pending final FDA approval.