Shares of Zydus Lifesciences were trading higher by 1% on 1 October after the company announced that it had received an ‘Establishment Inspection Report (EIR)’ from the USFDA (United States Food and Drug Administration). 

The US health regulator conducted an inspection at the company’s transdermal patch manufacturing facility in Pharmez, Ahmedabad, between 15 July and 19 July. The USFDA concluded the inspection by issuing an EIR for the facility, classifying it as ‘Voluntary Action Indicated’ (VAI).

Earlier in August, the health regulator issued a warning letter to the company’s drug manufacturing facility in Jarod, Gujarat, after conducting an inspection in April 2024. The inspection called attention to inadequate Current Good Manufacturing Practices (CGMP), especially related to cross-contamination, poor aseptic procedures, and particulate contamination. 

The USFDA observed multiple issues, including improper investigation of product discrepancies, inadequate cleaning procedures causing cross-contamination between drug products, and insufficient protocols to prevent microbial contamination in sterile drugs. Additionally, glass particulate contamination was detected in several batches of Cyanocobalamin Injection, raising further concerns about the manufacturing processes. 

These violations point to significant lapses in maintaining the necessary standards for drug safety and quality control.

At 3:30 pm, the shares of Zydus Lifesciences closed 1.24% higher at Rs 1,081.80 on NSE.

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