Drug Approval | October 05, 2025
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
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The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.
The goal is to deliver greater value to customers, doctors, and the broader healthcare ecosystem
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings
Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
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