NDMA In Ranitidine Risks Rerun Of Sartans Crisis
Regulators in North America and Europe are reacting to the discovery of the impurity NMDA in ranitidine, just over a year after similar impurities in sartan products led to a slew of recalls and withdrawals around the world.
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EU Regulators Prioritize Nitrosamine Evaluations Deadline
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
Nichi-Iko Moots Digital Joint Venture
Nichi-Iko is exploring the possibility of a joint venture with digital services provider MedPeer, building on a collaboration that the Japanese generics firm believes will represent a “new generic drugs business model.”
FDA Warning Letter Blasts Glenmark
Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.