Mylan's Manufacturing Maelstrom: Trans-Atlantic Recalls And Personal Citation By Gottlieb
GMP quality, once Mylan's calling card, is now an ongoing problem, forcing product discontinuations and apologies to customers. Firm's valsartan products have European certificate of suitability suspended as Morgantown, W.Va. facility draws US FDA warning letter.
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Visible Particles, Drug Shortages, DSCSA Spotlighted In CDER’s 2020 Quality/GMP Guidance Agenda
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Swift And Nimble – Alembic Laps Up US Valsartan Windfall In Q2
Alembic moved fast and seized supply opportunities for valsartan, the hypertension drug that has seen shortages in the US, though management maintains that fundamental changes to the US market are there to stay given the backdrop of buying power of distributors.