Zydus Lifesciences Clears Up USFDA Warning Letter Impact

4 Sep 2024 , 09:39 AM

Zydus Lifesciences Ltd clarified a recent warning letter from the US FDA regarding its Jarod, Gujarat, injectable manufacturing facility.

The warning letter outlines issues related to current good manufacturing practices (cGMP) and requests a response within a specified timeframe. Zydus confirmed that it is already addressing the FDA’s concerns with corrective and preventive actions.

At the time of writing on September 4, 2024 at 9:33 am, Zydus Lifesciences Ltd shares were trading 0.49% higher at ₹1119. Zydus Lifesciences Ltd stock has seen a 60% gain over the past six months. Zydus Lifesciences Ltd stock has gained a total of 80% in the last one year.

The warning letter, received on August 30, 2024, will not affect product supply to the US or the company’s financial performance. Zydus reassured that operations and financials will remain unaffected by the warning letter. The company’s corrective measures are in progress to meet the FDA’s requirements.

Zydus reported a 21% year-on-year revenue increase for the first quarter, surpassing estimates of ₹5,646 Crore with a total revenue of ₹5,140 Crore.

Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company based in Ahmedabad.

The company specializes in manufacturing generic drugs and offers a wide range of products, including pharmaceuticals, diagnostics, herbal products, skincare items, and other over-the-counter (OTC) products.

Zydus operates 25 pharmaceutical production facilities across India, developing and manufacturing its extensive product lineup.

The company manufactures active pharmaceutical ingredients (APIs) at three major sites located in Ankleshwar, Vadodara, and Ahmedabad, India.