Zydus Lifesciences Ltd has received an ‘Establishment Inspection Report (EIR)’ from the United States Food and Drug Administration (USFDA) following an inspection conducted in July 2024.

The US health regulator inspected Zydus Lifesciences’ transdermal patch manufacturing facility in Pharmez, Ahmedabad, between July 15 and July 19, the company stated in an exchange filing.

The USFDA has now issued an EIR for the facility, classifying it as ‘Voluntary Action Indicated’ (VAI).

Shares of Zydus Lifesciences Ltd gained nearly 1% on Tuesday, reaching a session high of ₹1,075.7 per piece on the BSE.

In August, the USFDA issued a warning letter to Zydus Lifesciences’ drug manufacturing facility in Jarod, Gujarat, following an April 2024 inspection. The inspection highlighted inadequate Current Good Manufacturing Practices (CGMP), particularly related to cross-contamination, particulate contamination, and poor aseptic procedures.

Also read: Indian pharma giants draw FDA flak: A string of warnings in 2024 so far

The USFDA noted improper investigation of discrepancies, inadequate cleaning leading to cross-contamination between drug products, and insufficient procedures to prevent microbial contamination in sterile drugs, among other observations.

Additionally, glass particulate contamination was found in multiple batches of Cyanocobalamin Injection.

Zydus Lifesciences reported strong earnings for the first quarter of FY 2025.

Net profit for the April to June period surged 30.6% year-on-year (YoY) to ₹1,420 crore, compared to ₹1,087 crore last year, surpassing CNBC-TV18’s poll estimate of ₹1,136 crore.

On the international front, demand remained robust across key markets during the review period.

The Consumer Wellness business delivered industry-leading double-digit growth, driven by an improved demand scenario and an extended summer season.

At around 1:30 PM on October 1, shares of Zydus Lifesciences Ltd traded flat at ₹1,075.45 apiece, up 0.66% on the BSE.

The stock has followed an upward trajectory over the past year, delivering a return of over 75%. On a year-to-date basis, the stock has gained 54% in 2024. Over the past six months, the stock has risen 8%.