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The facility’s Plant II and Plant III, which are located at L 32, 33-34 at the Verna Industrial Estate had received an Official Action Indicated (OAI) classification from the US drug regulator on October 11.
The said facility was inspected between July 16 to July 26, 2024.
“The company remains closely committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis. We will work with the USFDA to resolve these issues at the earliest,” Indoco Remedies said in a statement.
A USFDA Warning Letter generally identifies the concerns like poor manufacturing practices, problems with claims for what a product can do or incorrect directions for use. Although Indoco has not specified the factors behind issuing the warning letter.
The warning letter also provides an opportunity for the company to address the concerns and respond within a specified timeframe.
Indoco added that it continues to supply products from the said facility to meet obligations to customers and patients in the US.
“We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across our facilities,” Indoco said.
Shares of Indoco Remedies are trading 7.1% lower at ₹316.5 post the announcement. The stock has been an underperformer so far in 2024, with declines of 18% so far.
First Published: Dec 17, 2024 11:43 AM IST
