Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
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 conference stressed a multi-dimensional approach required to address Antimicrobial Resistance (AMR), focusing on the right approach and strengthening awareness
The products include high-quality, advanced anti-infective formulations such as EMROK (Levonadifloxacin) and MIQNAF (Nafithromycin)
Four FDA-approved products strengthen portfolio and reaffirm commitment to global reach
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
Reinforcing commitment to ethical and sustainable growth
The partnership aims to co-develop technologies set to revolutionize manufacturing of plasmid DNA (pDNA), a critical raw material for advanced medicines
This case report is jointly authored by US clinicians from leading hospitals, Houston Methodist Hospital, Weill Cornell Medical College and Johns Hopkins
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