Cipla's Bengaluru plant gets single FDA observation after cGMP inspection
Published on 30/05/2025 08:06 PM
Cipla's Bengaluru plant gets single FDA observation after cGMP inspectionFor any FDA-approved facility, it is mandatory to conform to the US regulator's cGMP or current Good Manufacturing Practice regulations. Shares of Cipla Ltd ended at ₹1,464.85, down by ₹11.70, or 0.79%, on the BSE on May 30.By Jomy Jos Pullokaran May 30, 2025, 8:06:36 PM IST (Updated)2 Min ReadDrug major Cipla Ltd on Friday (May 30) said the United States Food and Drug Administration (FDA) has concluded a current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Bommasandra, Bengaluru.
"...we hereby notify that United States Food and Drugs Administration (‘USFDA’) has conducted a current Good Manufacturing Practices (‘cGMP’) inspection at the Company’s manufacturing facility in Bommasandra,
Bengaluru from 26th to 30th May 2025," the company said in a stock exchange filing.
The inspection, which took place between May 26-30, 2025, resulted in the issuance of one observation in Form 483. The company stated that it will work closely with the FDA to address the concern and remains committed to providing a comprehensive response within the stipulated timeline.
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What is CGMP?
For any FDA-approved facility, it is mandatory to conform to the US regulator's cGMP or current Good Manufacturing Practice regulations.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors following the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
After Form 483 is issued, the company is given 15 days' time to submit its response to the FDA explaining what steps it will take to resolve the observations.
Also Read: Cipla Q4 Results: Revenue up 9%, FY25 margin guidance surpassed
Shares of Cipla Ltd ended at ₹1,464.85, down by ₹11.70, or 0.79%, on the BSE.Continue Reading(Edited by : Shoma Bhattacharjee)First Published: May 30, 2025 8:06 PM ISTCheck out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!TagsCiplashare market today