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%.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • Sebi must not be lax in weeding out mutual fund houses

    Last May, capital market regulator Securities and Exchange Board of India (Sebi) amended the Sebi (mutual funds) regulations, 1996, directing all fund

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Arun Nigavekar

New model for effective education

After interacting with students and teaching community on a ...

Rajgopal Nidamboor

Let the spirit of sport pervade everyday life

Sport, like meditation, is nothing short of a spiritual act. ...

Shona Adhikari

Pop art is truly a feast for the eyes

The internationally reknowned Bruno Art Group’s presence in India had ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture