US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold

Sun Pharmaceutical Industries seems to have suffered a setback as the US Food and Drug Administration (FDA) has placed its Halol plant under ‘official action indicated’.

FP Trending March 30, 2020 11:16:34 IST
US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold

Sun Pharmaceutical Industries seems to have suffered a setback as the US Food and Drug Administration (FDA) has placed its Halol plant under ‘official action indicated’.

US Food and Drug Administration flags Sun Pharmas Halol plant warns product approvals may be put on hold

Representational image. Reuters

Informing about this to the stock exchanges on 29 March, the company said that FDA approvals for products manufactured at its plant in Gujarat’s Halol may be put on hold.

The Dilip Shanghvi-led company also faces the risk of getting a warning letter from FDA, which expects the pharma company to take corrective action at the plant.

Although Sun Pharma’s dependence on the Halol plant for its exports to the US has come down over the years, supplies to the country still contribute approximately 3 to 4 percent of its consolidated revenues.

In a letter to BSE, Sun Pharma informed that product approvals for US market may get postponed till the plant starts working in line with FDA norms. However, the current orders will be dispatched as per schedule.

The company said that it does not see any major supply disruption due to the new norm and it will work with the regulator to ensure that there will be no shortage of supply to the US.

The letter also mentioned that a re-inspection of the plant is also possible. The FDA conducted inspection of the plant in December. But, in view of the rapid spread of coronavirus, the inspection may be delayed.

 

Updated Date:

also read

Delhi records 1,530 Covid cases, 3 deaths; positivity rate rises to 8.41 %
Health

Delhi records 1,530 Covid cases, 3 deaths; positivity rate rises to 8.41 %

The fresh infections pushed Delhi's Covid case tally to 19,22,089 while the death toll rose to 26,232

Up in smoke: Why US has ordered leading vaping company Juul to pull e-cigarettes off the shelves
World

Up in smoke: Why US has ordered leading vaping company Juul to pull e-cigarettes off the shelves

The Food and Drug Administration banned all Juul products from the United States after recognising it 'played a disproportionate role in the rise of youth vaping'

Market Roundup: Sensex jumps 443 points, Nifty ends at 15,556; check top winners and laggards
Business

Market Roundup: Sensex jumps 443 points, Nifty ends at 15,556; check top winners and laggards

All sectoral indices, except for oil and gas, ended higher. BSE Smallcap and Midcap indices gained over one per cent