CDMO strengthens global quality framework through digital transformation, AI-enabled investigations, workforce development and continuous audit readiness
The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
Hikal’s Q4 profit remained sharply lower year-on-year, falling 71% from Rs. 50.2 crore in Q4 FY25 as the company absorbed regulatory pressures and strategic accounting adjustments
The approval was granted by Agenzia Italiana del Farmaco
The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval
The two companies will establish a joint Center of Excellence (CoE) in Bengaluru
The renewal covers two versions of the IQOS device and three HEETS tobacco variants
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
Company confirms seized products were not from its authorised supply chain and urges patients to purchase medicines only through licensed pharmacies
API-first, DPI-driven DDRS platform aims to modernize drug and medical device regulation in India
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