
USFDA inspections to be less disruptive for Indian pharma sector: Report
Indian pharma companies have increasingly de-risked their operations by slowly and steadily increasing sales to non-US markets, says India Ratings and Research.
Indian pharma companies have increasingly de-risked their operations by slowly and steadily increasing sales to non-US markets, says India Ratings and Research.
USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved, says Cipla.
This smallcap stock has more than doubled investors’ money in 12 months, rising from its 52-week low of ₹197.50 to an all-time high of ₹461.95 in intraday trade on the BSE.
The problems faced by FDA’s investigators in India are similar to those around the world, US Food and Drug Administration spokesperson Jeremy Kahn tells Fortune India.
Three firms have applied for emergency use authorisation in India as of now. AIIMS’ Amit Dinda, who is a part of the Global Coalition for Regulatory Science Research, explains the regulatory nuances.
The difference between industry-leading firms and the rest is the unrelenting focus of the leading ones on brand creation, production and supply chain processes, and product innovation.
India’s third-largest generic drugmaker Lupin is focussing on building a pipeline of specialty drugs, while cutting costs and addressing regulatory concerns.
Biocon CMD Kiran Mazumdar Shaw speaks to Fortune India on the sidelines of the USIBC India Ideas Summit; says U.S. and India are natural synergistic partners.