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CASE STUDY 3 - ROUND 1: Critical Review of Quality and Manufacturing Data


Jun 17, 2021 5:00am ‐ Jun 17, 2021 5:40am


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CASE STUDY 3 - ROUND 1: Critical Review of Quality and Manufacturing Data | Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge. Emer-Pen is used in life-threatening emergencies prior to gaining access to qualified medical care. Approximately 4 million packs (2 devices per pack) were prescribed in the local market during financial year 2015-16.

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