Hyderabad API Manufacturer Achieves EU GMP Certification and Unlocks EUR 8M Annual EU Contract

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

India-EU

Challenge

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.

Solution

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.

Outcome

EU GMP certificate obtained at month 19. EDQM CEP granted at month 22. First commercial EU shipment at month 24. Annual EU contract value: EUR 8.2 million. ECGC Standard Policy secured for the German buyer relationship. RoDTEP benefit on API exports calculated at 2.1% of FOB value.

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