
Built on Trust: Our Global Regulatory Footprint
In the pharmaceutical world, trust is not given, it is built through rigorous compliance. At Coral Drugs, we recognize that global market entry requires more than high-quality products. It demands consistent adherence to international standards, transparent documentation, and a regulatory track record that instils confidence in every partner we work with.
With over 30 Drug Master Files (DMFs) filed across the US, EU, Mexico, Japan, Korea, India, and other regulated regions, Coral Drugs has established a truly global regulatory footprint. These filings reflect our ability to support clients worldwide, helping them navigate complex compliance frameworks with ease.
Our facilities are designed for inspections, with practices aligned to cGMP and GLP. Every process is validated, every system audit-ready, and every step fully traceable. This robust foundation ensures that our partners can rely on us to meet not only current compliance requirements but also evolving regulatory expectations across diverse markets.
From submission to scale-up, Coral Drugs provides the expertise and infrastructure that enable confident entry into regulated markets. By prioritizing quality, safety, and compliance, we stand as a trusted partner, supporting pharmaceutical innovation on a global scale.
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