CNBC-TV18 has accessed Form 483 issued to Torrent Pharmaceuticals's Chhatral unit in Gujarat. The US health regulator has issued five observations to the pharmaceutical company after inspecting its site from December 5 to December 11.
The observations by US Food and Drug Administration (USFDA) include:
- Failure to thoroughly review any unexplained discrepancy
- Responsibilities and procedures applicable to quality unit are not in writing and fully followed
- Equipment and utensils not cleaned and maintained to prevent at appropriate intervals
- Components of drug product manufacturing are not weighed and measured
- Accuracy, sensitivity, specificity and reproductibility of test methods not established.
The company reported a 23.7% year-on-year rise in net profit at ₹386 crore for the second quarter that ended September 30, 2023. Its total revenue was at ₹2,660 crore, a jump of 16.1% against ₹2,291 crore in the corresponding period of the preceding fiscal.
Shares of Torrent Pharmaceuticals Ltd were trading 0.43% higher at ₹2,306.25 apiece on the NSE. The scrip has risen over 20% in the last six months.
First Published: Jan 2, 2024 11:33 AM IST
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