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
Surgical site infections and antimicrobial resistance remain major challenges globally
These initiatives will harness top scientific talent and advanced AI technologies to develop new ways to slow the rise of drug-resistant infections
The formulation is backed by over 80 clinical trials and 200 scientific publications
New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris
INEOS production of BDO in Germany, which produces a vital ingredient for antibiotics, statins and vitamin B6, is being crushed by a flood of carbon heavy imports and product dumping from the Far East
Conventional plasmids as a pharmaceutical material are not only suboptimal in safety and function, but exceedingly costly to produce, prohibitively
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 lab will facilitate the development of herbal and natural-based solutions
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