News | September 05, 2025
FDA completes inspection at Biocon Biologics' facility in Bengaluru
The U.S. FDA issued a Form 483 with five observations
The U.S. FDA issued a Form 483 with five observations
Data highlight ambition to transform prevention and treatment for serious bacterial infections and develop novel preventative strategies for respiratory viral infections
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
He has 29+ years’ comprehensive experience in world-class Formulations and API (for US and EU requirements) mainly related to injectables
Infections with H. pylori affect over 43 percent of the world’s population with a wide range of gastrointestinal disorders
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases
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