Arpit Bhatia Says EU GMP Fuels Laborate Pharma Growth

The EU GMP certification has significantly enhanced the alignment of Indian pharmaceutical manufacturing facilities with global quality standards, according to Arpit Bhatia, director of Laborate Pharmaceuticals.

This certification serves as a testament to a manufacturer's adherence to the European Union's rigorous quality, safety, and efficacy requirements for medicinal products, following a successful inspection by a European authority.

Established in 1985 in Panipat, Haryana, Laborate Pharmaceuticals ranks among India's leading pharmaceutical manufacturers, boasting revenues exceeding Rs. 1,600 crore and a diverse range of affordable medications.

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The recent acquisition of EU GMP certification positions the company to broaden its global export capabilities. Bhatia notes that this certification has mitigated perceived risks for buyers and regulators in Europe and other regulated markets, facilitating access to dossier submissions, tenders, and long-term supply contracts that were previously unattainable.

Furthermore, he emphasizes that EU GMP has shifted the focus from mere production capacity to establishing credibility, fostering an internal culture where practices such as data integrity, serialization, change control, and continuous process verification become ingrained in daily operations rather than treated as isolated projects.

Commenting on EU GMP standards influence on India’s pharmaceutical exports and competitiveness, Bhatia says, “Compliance changes both product strategy and market strategy. On product strategy, you build dossiers with stronger comparability data, robust stability, and lifecycle management from the outset. That makes the portfolio export ready rather than retrofitted for different regions.

 On market strategy, EU GMP improves our eligibility for procurement, whether hospital tenders in the EU, institutional buyers in Latin America, or public health programmes in Africa. It also improves our negotiating position with distributors and partners because the quality conversation is settled.

Over time, this translates into better realisation, longer contracts, and more predictable demand. The knock-on effect is investment confidence. When the compliance base is strong, you can justify new lines, new forms, and technology upgrades that keep you competitive across geographies.”