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
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025
India Formulation sales accounted for 34.2% of total consolidated sales for the quarter
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
Granules India receives 1 observation from USFDA for Chantilly facility
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