Hikal Ltd., a preferred long-term partner to leading global life sciences companies, has inaugurated its state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at the company’s Integrated Innovation Centre in Pune.

This world-class facility marks a major milestone in Hikal’s innovation journey, further strengthening its end-to-end Contract Development and Manufacturing Organisation (CDMO) capabilities. It enhances the company’s ability to safely develop, test, and deliver highly potent compounds for the global pharmaceutical industry.

The new cGMP-compliant HPAPI Laboratory features advanced isolators designed to meet Occupational Exposure Band 5 (OEB-5) standards. It is purpose-built to support the development of complex oncology and specialty molecules, including components of antibody drug conjugates (ADCs), peptide drug conjugates (PDCs), and proteolysis-targeting chimeras (PROTACs).

“Our new HPAPI laboratory represents a crucial step forward in expanding our capabilities and reinforcing our unwavering commitment to innovation, safety, and customer excellence,” said Sameer Hiremath, Vice Chairman and Managing Director, Hikal Ltd. “With this addition to our technology portfolio, we are well positioned to meet the growing global demand for potent molecule development while maintaining the highest standards of containment and compliance.”

The facility includes segregated entry and exit points for personnel and materials, full sequence control from raw material dispensing to final packing within isolators, and integrated milling operations to meet precise particle size requirements. It also features advanced analytical tools such as HPLC and GC for in-lab testing of HPAPIs, robust containment systems maintaining OEB-5 exposure control, and validation through independent third-party surrogate testing.

Complementing Hikal’s existing validation, process safety, solid state, flow chemistry, instrumentation, and synthesis laboratories, the HPAPI Lab creates a fully integrated innovation ecosystem at the Pune site. This ecosystem supports seamless project transitions from early-stage research to commercial manufacturing, across scales ranging from milligrams to over 100 kilograms in the pilot plant.

With more than three decades of experience scaling molecules from clinical to commercial production, Hikal remains a trusted partner for the pharmaceutical, animal health, and specialty chemicals industries. Founded in 1988, the company continues to enable innovation-driven development and manufacturing of APIs and AIs while upholding world-class ESG standards.