Eliminating capsule leakage to secure faster regulatory drug approval

A leading Indonesian pharmaceutical manufacturer faced this very challenge in its band-sealing process, putting a high-stakes drug launch in jeopardy. Mecobalamin (Vitamin B12) manufactured by Indonesia’s top CMO was nearing registration with BPOM, Indonesia’s regulatory authority. The manufacturer found itself navigating a high-stakes deadline under intense compliance pressure. What began as an urgent need for regulatory readiness soon evolved into a collaborative transformation that extended well beyond capsule supply.

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Eliminating capsule leakage to secure faster regulatory drug approval

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