USFDA raises concern over drug production process at Cadila

Tags: Cadila, USFDA, 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

  • India cannot afford to ignore the looming Greek crisis

    The crisis in Greece may not have a direct bearing on the Indian economy because the trading or banking exposure of Indian companies to that nation is

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

Sarthak Raychaudhuri

vice-president, HR, Asia South Whirlpool of India

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

TODAY'S COLUMNS

Arun Kumar Jain

A complex challenge for our PSUs

Till the mid-1990s, the central government and its companies were ...

Kuruvilla Pandikattu SJ

The transforming qualities of love

The 2015 Templeton Prize has been awarded to Canadian thinker ...

Dharmendra Khandal

The one in which a blue whale was washed ashore

Quite unexpectedly, a gigantic blue whale was washed ashore at ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture