US watchdog flags issues at Sun Pharma’s Halol plant

NEW DELHI: Sun Pharmaceutical Industries Ltd, India’s largest drug maker, on Friday said the US Food and Drug Administration (FDA) had made three observations after inspecting its factory at Halol in Gujarat, for failing to meet good manufacturing practice standards.

“The US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceuticals Industries Ltd’s Halol facility. At the conclusion of the inspection, the agency issued a Form 483 with three observations,” the drugmaker said in a regulatory filing. The inspection was conducted between February 12 and February 23.

The shares ended 5.17% higher to close at ₹570.20 on the BSE on February 23.

Sun Pharma’s US supplies were hit over the past year after the US FDA found violations of manufacturing practices at the company’s Halol manufacturing unit. US FDA conducted its first inspection of the facility in 2014 and another in December 2015. The company was given a warning letter with six observations, preventing it from making fresh filings of new drug applications.

In November-December 2016, Sun Pharma’s Halol unit was reinspected and the US FDA issued Form 483 with nine observations. The FDA inspectors found the drugmaker’s testing programmes inadequate and said the company had failed to report potential contamination issues on time. As per the US health regulator, observations are made in Form 483 when the investigators feel conditions or practices in a facility are such that products may become adulterated or could be injurious to health.

The facility at Halol, one of Sun Pharma’s biggest units, holds the key to its US formulation business. Sun Pharma gets about half of its revenue from the US market and the Halol unit contributes a majority of its drug filings.

Barred from new drug filings in the American market, the company’s US business has been severely impacted in last couple of years.