Why This Pharma Firm's Shares Are Sinking After US FDA Notice

Drugmaker Ipca Laboratories‘ shares were languishing in the red on Wednesday after an inspection by the US Food and Drugs Administration (FDA) notified the firm of manufacturing-related issues at its plant in Madhya Pradesh.

What Happened? The US FDA conducted an inspection of the pharma company’s active pharmaceutical ingredients manufacturing facility in Ratlam, Madhya Pradesh and issued a form 483 with 11 observations.

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A Form 483 contains observations made by US FDA inspectors regarding non-compliance with current manufacturing standards that may affect the safety, quality, or effectiveness of the products manufactured by the company. It serves as a notice to the company, providing them with an opportunity to address and correct the identified issues.

Ipca said it “will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.”

The notice comes at a time when top Indian pharmaceutical companies, including giants like Sun Pharma, Cipla, and Lupin, have come under scrutiny from the US FDA for lapses in the manufacturing of exported drugs.

Price Action: Shares of Ipca sank 2.70% to ₹715 in late morning trade on Wednesday.

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