Page 12 - Us Fda

Expansions, clean track record helping Divi's Labs tap new opportunities

The current margin pressure will also get mitigated by tax benefits and operational efficiencies

Aurobindo recalls heartburn drug ranitidine, two others from US market

Development follows regulatory compliance issues being faced by several of its plants back home; Ranitidine taken off due to the presence of carcinogenic compound

Caplin Steriles gets US FDA approval for generic blood pressure drug

The company has so far developed and filed 13 ANDAs on its own and with partners, and received six approvals

Zydus Cadila gets US FDA approval for generic muscle relaxing injection

The approval is for single-dose vials of Cisatracurium Besylate Injection USP with strengths of 10 mg/5 ml and 200 mg/20 ml

Cadila Healthcare receives US FDA approval for schizophrenia drug

The product will be manufactured at Liva Pharma's manufacturing facility at Vadodara

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