WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
The accelerated review covers WCK 5222 for multiple critical infections
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
The products include high-quality, advanced anti-infective formulations such as EMROK (Levonadifloxacin) and MIQNAF (Nafithromycin)
Consolidated revenue from operations in the quarter was marginally down at Rs 738 crore a
Wockhardt also saw its revenue from operations increased 3% to Rs. 721 crore during Q3 FY25
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
Wockhardt plans to launch Miqnaf in the Indian market in coming few months
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