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
The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players
Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO
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