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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The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
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.
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.