REGULATORY INTELLIGENCE·Recall
Shilpa Medicare Azacitidine Recall: CGMP Deviations Highlight Critical India-US Supply Chain Risks
Shilpa Medicare Limited initiated a Class II recall of 35,931 vials of Azacitidine for Injection due to CGMP deviations at its Polepally, India facility. This event, distributed by Armas Pharmaceuticals Inc. in the U.S., underscores critical supply chain vulnerabilities for essential oncology drugs. Procurement and regulatory teams must scrutinize supplier quality systems and diversify sourcing to mitigate disruption and ensure patient safety.
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