Cipla Share Price Falls 2% After USFDA Issues Six Observations at Goa Site

Cipla share price dropped by 2% in early trading on June 24 following the company's receipt of six observations from the USFDA. As of 09:23 am IST, Cipla share price was trading at ₹1,510.90, down ₹30.05 or 1.95% on the BSE.

The USFDA conducted an inspection at Cipla's manufacturing facility in Goa, India, from June 10 to June 21, 2024. Following the inspection, the company received six inspectional observations documented in Form 483.

"We hereby notify that the USFDA has conducted an inspection at the company's manufacturing facility in Goa, India from 10th – 21st June 2024. On conclusion of the inspection, the company received six inspectional observations in Form 483," Cipla said in a regulatory filing.

Cipla has assured stakeholders that it will collaborate closely with the USFDA to thoroughly address these observations within the stipulated timeframe. "The Company will work closely with the USFDA and is committed to addressing these comprehensively within the stipulated time," the statement added.

A Form 483, an important component of the regulatory process, is a list of observations made during an inspection, issued by USFDA inspectors upon completion. During the closing conference, the inspector will communicate and explain these observations to the supplier. However, Form 483 does not constitute a final FDA determination regarding the facility's GMP compliance.

After a Form 483 is issued, the company has 15 days to submit its response to the USFDA. In this response, the company must explain the steps it will take to address and resolve the observations made by the USFDA.

On June 19, 2024, the share price reached a 52-week high of ₹1,581.70, while on June 23, 2023, it hit a 52-week low of ₹985.00. Currently, the stock is trading 4.48% below its 52-week high and 53.39% above its 52-week low. Over the past year, the shares have increased by 49%.

Cipla is a global pharmaceutical company dedicated to agile and sustainable growth, specializing in complex generics and expanding its portfolio in key markets such as India, South Africa, North America, and other regulated and emerging markets. In Q4 FY24, the company reported a 79% increase in consolidated net profit, reaching ₹939.04 crore, and a 10% rise in revenue from operations, totaling ₹6,163 crore, compared to Q4 FY23.