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

  • Legalising betting on cricket will raise tax collections for cash-strapped government

    Last month, Justice RM Lodha committee on cricket reforms made several groundbreaking recommendations to the Supreme Court.

FC NEWSLETTER

Stay informed on our latest news!

TODAY'S COLUMNS

Arun Nigavekar

Tablets, memory cards for educatioNext

The Commonwealth he­ads of government mee­ting held in Malta last ...

Rajgopal Nidamboor

Try to awaken the archaeologist within

Our mind is far ahead of René Descartes’ famous maxim, ...

Dharmendra Khandal

Urbanisation is costing us our wildlife

The road transport and highways minister Nitin Gadkari aims to ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture