Shares of Cadila Healthcare fell as much as 4.7% after the company said that it has received a warning letter from US Food and Drug Administration (USFDA) following a pre-approval inspection of new injectable facility in Gujarat.
The shares of CadilaHealthcare closed at Rs. 933.25. It touched a day’s high of Rs. 952.00 and alow of Rs. 904.00. The total traded quantity stood at 2,30,323 shares on theBSE.
"We are addressing the issue expeditiously to resolve the matter. We do not expect any impact on our current business," Cadila Healthcare said in a statement, without divulging further details.
The US drug regulator said it had identified significant violations of CGMP regulations for finished pharmaceuticals during its inspection of the company’s plant at Sanand in Gujarat.
Cadila Healthcare's formulation plant at Moraiya in Sanand makes tablets, capsules and soft gel capsules besides injectable drugs in both sterile liquid and lyophilised forms.
At 2:51 pm (IST), the stock was at Rs. 931.25, down Rs. 17.45 or 1.8% over the previous close. It had earlier been as low as Rs. 904 and as high as Rs. 952. It opened at Rs. 948.
More than two lakh shares changed hands on the counter on the BSE as against a two-week average of 9,554 shares.
The USFDA, which inspected the plant between January 17 and February 3, said that it had reviewed the company's response to its observations on February 10, and noted that it lacks sufficient corrective actions.
“Your company’s laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards," the USFDA said.
The USFDA has given Cadila Healthcare 15 days to notify the steps it has taken to correct the violations.
It also warned that it could withhold the approval of any new applications until all corrections have been completed and it has confirmed corrections of the violations.
India Infoline News Service / 11:17, Apr 24, 2015
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