(Repeats to add sources to headline)
MUMBAI, July 31 The U.S. Food and Drug
Administration (FDA) has expressed concerns over the
manufacturing process of at least one product at Indian
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 U.S. 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 the western
Indian state of Gujarat, in the second week of July, one of the
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 percent on Thursday
and were trading down 4 percent at 1,120.90 rupees at 0705 GMT,
while the main market index was down 0.1 percent.
(Reporting by Abhishek Vishnoi and Zeba Siddiqui; Editing by
Sumeet Chatterjee and Matt Driskill)