Indoco Remedies share price falls over 4% as Goa unit gets 4 USFDA observations
Indoco Remedies shares fell 2% as USFDA inspected its Sterile Facility in Goa from Feb 20-28, 2023, and classified it as OAI with four observations.
PremiumIndoco Remedies shares slumped over 4% on Monday's trading session after the company informed the exchanges that its Sterile Facility (Plant II) located at Goa has received four observations in form 483 issued by the United States Food and Drug Administration (USFDA). In the early trade the stock slipped over 2%. Indoco Remedies share price opened at the day's intraday high level of ₹354.75 apiece on BSE.
In its exchange filing, the company stated that the USFDA inspected its Sterile Facility (Plant II) from February 20, 2023, to February 28, 2023, and determined that the facility's inspection status was Official Action Indicated (OAI).
Additionally, the company stated in its exchange filing that it is dedicated to working with the USFDA to address the issues with the utmost urgency.
“We have done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe, " said Aditi Panandikar, Managing Director of the company.
The company further stressed that the inspection classification won't affect the facility's current supplies or revenue.
On the other side, in July 2022, the USFDA conducted a remote inspection of the company's Hyderabad-based clinical research organisation, AnaCipher, but found no objectionable conditions there.
The company stated in an exchange filing that the USFDA's certification follows the FDA's seventh consecutive inspections, which resulted in ZERO 483s for AnaCipher CRO.
“We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients," said the company in an exchange filing.
On the technical front, the stock price fell 4.6% and underperformed its sector by 15.7% in the past year, as per trendlyne data.
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