USFDA raises concern over drug production process at Cadila

Tags: News
The US Food and Drug Administration (FDA) has expressed concerns over the manufacturing process of at least one product at drugmaker Cadila Healthcare Ltd's Moraiya facility, two sources with direct knowledge of the matter said.

The FDA has not expressed concerns over the entire facility, said the sources. The US agency communicated its concern to Cadila in a Form 483, a letter in which the agency typically outlines violations of standard manufacturing practices.

Once the Form 483 is sent, the company has 15 days to respond before the FDA takes any further action.

The FDA inspected the Moraiya plant, based in Gujarat, in the second week of July, one of the sources said.

The sources declined to be named as the information is not public yet. A Cadila spokeswoman declined to comment.

Cadila's shares dropped as much as 10.5% on Thursday and were trading down 5.3% to Rs 1,106.50 at 1:01 pm., while the broader Nifty was down 0.22%.

EDITORIAL OF THE DAY

  • Gauging by the enormity of the coal scam, the convictions of three civil servants are hopefully just the beginning

    Zero tolerance against corruption must be the message that goes down the line with the CBI special court sentencing three top civil servants to two ye

FC NEWSLETTER

Stay informed on our latest news!

TODAY'S COLUMNS

Sandeep Bamzai

Cut & Thrust: Islam’s dance of death

It is a short walk between victim hood and blood ...

M S Swaminathan

Green revolution@50

The green revolution was a transformational event changing our agricultural ...

Zehra Naqvi

Mindful meditation in everyday life

Amid the vast multitude of tasks and huge amounts of ...