Sun Pharma’s Halol facility has been placed under an import alert by the FDA following an inspection earlier this year that uncovered GMP deficiencies.
Sun Pharmaceutical Industries has received a blow from the US Food and Drug Administration after the US agency imposed an import alert on its Halol, Gujarat manufacturing site in India.
Earlier this year, the Halol facility had received 10 “Form 483” observations of deviations from current good manufacturing practice following an FDA inspection which ran from 26 April to 9 May
Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.
Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
