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API contract manufacturer·Austria·2020–2022

GMP finding halted two product lines; key account at 60 % of revenue

Scale: 90–120 employees, revenue approx. EUR 52m

7 months
to GMP clearance
3 years
key account renewal
EUR 4.5m
bridge facility

Situation

Following a GMP finding by the regulator, the plant had to halt shipment of two product lines. The largest customer accounted for roughly EUR 31m in annual revenue — 60 % of the business — and was already assessing a move to a competitor. Without clearance, insolvency was a quarter away.

Approach

Working with external GMP specialists, we set up a remediation plan and tracked delivery against it weekly. The second, equally important part was communication: we briefed the key account every two weeks with evidenced progress rather than assurances. A EUR 4.5m bridge facility was structured, secured against plant and machinery.

Outcome

Regulatory clearance after seven months. The key account stayed and renewed for three years in 2022. Revenue returned to EUR 49m in 2022. The bridge facility was repaid on schedule.

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