API In Ducts And Filters Led To Cipla’s First Drug GMP Warning Letter
Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.
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Suanfarma acquires an API manufacturing facility in Italy to accelerate its growth in Europe, while CapsCanada relocates its headquarters as part of its growth strategy. Meanwhile, Glenmark, Aurobindo and Cipla struggle with quality issues.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.