The Challenge
BharatPharma Exports manufactured Active Pharmaceutical Ingredients (APIs) for the domestic market but had ambitious plans to export to Germany, France, and the Netherlands. The barrier was enormous: EU-GMP (Good Manufacturing Practice) certification, REACH compliance for chemical substances, DMF (Drug Master File) submissions to EMA, and navigating the EDQM Certificate of Suitability process. The compliance journey was estimated at ₹45 lakh and 18 months — and they had no idea how to find European distributors even after achieving certification.
The Sell Around Solution
Sell Around partnered with BharatPharma through its Export Compliance Advisory program. The platform provided a step-by-step EU-GMP compliance roadmap, connected them with a certified EU-GMP consultant, and tracked their certification milestones. Once WHO-GMP certified, BharatPharma listed their API portfolio on Sell Around's B2B pharma marketplace. Sell Around's EU Buyer Discovery matched their APIs to 12 European distributors. The WhatsApp bot was configured to share COA (Certificate of Analysis), SDS (Safety Data Sheet), and product specifications instantly to qualified buyers.
Why EU Pharma is the Ultimate Export Opportunity for Indian Manufacturers
India is the world's 3rd largest pharmaceutical producer by volume and the largest supplier of generic medicines globally. Yet only 12% of Indian pharma companies export to the EU — because EU-GMP compliance is genuinely complex. Sell Around's compliance roadmap changes this.
The EU-GMP certification path for APIs: (1) Gap analysis against EU GMP guidelines (Part II), (2) Quality Management System (QMS) documentation, (3) FDA/WHO-GMP inspection preparation, (4) EMA EDQM submission for Certificate of Suitability, (5) EU competent authority inspection. Each step has specific document requirements — Sell Around's template library covers all of them.
The REACH Compliance Challenge
For chemical APIs exported to the EU, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) registration is mandatory for substances imported in volumes above 1 tonne/year. BharatPharma used Sell Around's REACH compliance toolkit to identify which of their 23 API products required registration, calculate registration costs, and connect with an Only Representative (OR) in the EU to handle the registration on their behalf.
"The EU pharma market was always our dream but seemed impossibly complex. Sell Around broke down the compliance journey into achievable steps and then connected us with the right European partners. Our first EU shipment to a German pharma distributor was ₹48 lakh."