USFDA approvals for products manufactured at Sun Pharmaceutical Industries’ Halol plant in Gujarat may be put on hold after the regulator placed it under ‘official action indicated’, the company informed the stock exchanges on Sunday.
With this, a risk of the US FDA issuing the company a warning letter exists. The regulator expects the Dilipn Shanghvi company to take corrective action at the plant.
US supplies from Halol, as of now, contribute approximately 3-4% of Sun’s consolidated revenues. The dependence of the company’s on the plant for its exports to the US has come down over the years. “In their communication, the USFDA has mentioned that they may put all new approvals from the Halol facility on hold.