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A Mumbai-based generic pharmaceutical company wanted to export finished dose tablets to EU but had no EU marketing authorisation (MA). They had approached two EU regulatory consultants who quoted EUR 500,000 and 5 years for a centralised EMA procedure. The company needed a faster, more capital-efficient market entry route.
AJG connected the company with a Netherlands-based generic pharma distribution partner who already held MAs for 12 generic products in EU. A licensing agreement was structured: the Indian manufacturer would supply the product in bulk to the Dutch partner who held the MA, distributed to EU, and paid the Indian manufacturer on a cost-plus basis. AJG facilitated the commercial negotiation of the supply and licensing agreement over 4 months.
First EU shipment completed within 14 months of mandate commencement. Indian manufacturer generates EUR 2.8M annually from EU supply under the licensing arrangement. The Dutch partner handles MA maintenance, EU pharmacovigilance, and distribution. Indian manufacturer now investing in their own EU MA for 3 products using profits from the licensing income.
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