Hikal inaugurates High Potency API lab at Pune

Written By : Ruchika Sharma Published On 2025-10-16T17:00:33+05:30 | Updated On 16 Oct 2025 5:00 PM IST

Pune: Hikal Ltd., the preferred long-term partner for global life sciences companies, has announced the inauguration of its state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at its Integrated Innovation Centre in Pune.

This world-class facility strengthens its end-to-end CDMO capabilities and enhances its ability to safely develop and test and deliver highly potent compounds for the global pharmaceutical industry.

The new cGMP-compliant HPAPI Laboratory is equipped with state-of-the-art isolators designed to meet Occupational Exposure Band 5 (OEB-5) requirements. The lab 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 critical step forward in expanding our capabilities and reinforcing our unwavering commitment to innovation,safety and customer excellence,” said Sameer Hiremath, Vice Chairman & Managing Director, Hikal Ltd. “With this new addition to our technology toolbox, we are well positioned to meet the growing demand for potent molecule development while maintaining the highest global standards of containment and compliance.”

Key Features of the Facility

 Segregated entry and exit for personnel and materials to ensure safe operations

 Complete sequence control from raw material dispensing to final packing within isolators

 Built-in milling operations to meet precise particle size requirements during development

 Advanced analytical capabilities including HPLC and GC for in-lab analysis of HPAPIs, avoiding cross-contamination

 Stringent containment systems, maintaining exposure control to OEB 5, validated through independent third-party surrogate testing.

The HPAPI Lab complements Hikal’s existing validation lab, process safety lab, solid state lab, flow chemistry lab, instrumentation and synthesis laboratories.

Established in 1988, Hikal is a partner to companies in the Pharmaceutical, Animal Health, Biotech, Personal Care and Specialty Chemical industries. The company manufacture and supply quality Active Ingredients, Intermediates, Biocides to the global life sciences industry. Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani) and a world-class Research & Technology Innovation centre at Pune. Its facilities have been inspected and certified by Global Regulatory Authorities.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751