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A mid-sized Hyderabad-based API manufacturer had WHO-GMP certification and was supplying Indian domestic pharma companies. They identified a EUR 8M annual opportunity with a German generics manufacturer who required EU GMP-certified API facilities. The manufacturer had no EU GMP certification, no CEP from EDQM, and no familiarity with the EU regulatory pathway. They estimated the entire qualification process would take 5-7 years.
AJG facilitated an introduction to a specialised EU regulatory consulting firm in Frankfurt. A gap analysis against EU GMP Annex 15 (qualification and validation) and Annex 11 (computerised systems) was conducted. Facility upgrade investment of approximately INR 8 crore was structured over 18 months. CEP application was prepared concurrently with facility upgrades. The German buyer was engaged through AJG with a 24-month qualification timeline and a Letter of Intent signed at month 6.
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