Page 12 - Us Fda

Regulatory woes resurface for Indian pharma companies as stocks fall

Concerns over US sales are diluting positives of strong domestic growth, and have led to a 10 per cent fall in the Nifty Pharma index in one month

Rupee fall gives leg up to IT, pharma funds, may help ease margin pressure

IT and pharma funds have returned 4.4% and 1.77% in the past month, respectively

Tide turns for pharma as US FDA concerns get addressed

This indicates turn-of-the-tide of regulatory concerns raised by the US FDA in the last three years

US FDA steps add to pricing woes of pharma firms

FDA measures are part of its Drug Competition Action Plan

Another US warning on Indian drugs

US FDA India head gives more examples of lax quality here; urges firms to put onus on quality

Pharma barons swallow FDA bitter pill, Sun Pharma's Shanghvi biggest loser

Combined net worth of country's top 8 pharma promoters down by Rs 42,000 crore since 2015

Hitting the US FDA wall

Risks on account of regulatory overhang came to the fore again this week, with the US Food and Drug Administration (FDA) issuing a Form 483 for Lupin's Goa plant. Early resolution of the issue is crucial because the US market is important for most Indian companies. For example, Lupin's Goa plant and Cadila's Moraiya plant account for about 60 per cent of their US revenues and for most major Indian generic companies, the US accounts for 40 per cent of their global sales. There has been a 75 per cent increase in FDA inspections of facilities abroad in the past five years and 70 per cent of these result in a Form 483. While every Form 483 doesn't escalate into a warning letter, regulatory warnings over six months have heightened investor concerns and pushed earnings growth of domestic companies into an area of uncertainty. While analysts don't see it as a long-term risk, the FDA actions have led to a slew of earnings downgrades, on the back of US revenue loss, slower approvals and curren