“The commissioning of our cGMP pilot plant is an important step in strengthening Hikal’s pharmaceutical development and scale-up platform. It enhances our ability to support customers as they move from laboratory development to larger-scale, clinical development programmes, while staying anchored in quality, safety and compliance.” Sameer Hiremath, Vice Chairman and Managing Director of Hikal
Hikal Limited has announced the successful commissioning of its enhanced current Good Manufacturing Practice (cGMP)-compliant pilot plant facility at its Pune Research & Technology (R&T) campus. The expansion strengthens Hikal’s integrated capabilities across process development, scale-up, technology transfer and clinical-stage manufacturing at its Innovation Campus at Pune, enabling the company to partner more effectively with global pharmaceutical customers from early development through commercial manufacturing readiness.
The upgraded pilot plant supports process development, technology transfer and clinical-stage manufacturing while adhering to global quality and regulatory expectations. By creating a stronger bridge between laboratory-scale research and commercial-scale production, the facility is designed to help customers accelerate development timelines, improve process robustness and generate high-quality material for regulated development programmes. It also enables the manufacture and supply of preclinical and clinical-phase development materials from the same R&T campus, allowing scientists and engineers to closely monitor processes, enhance cross-functional collaboration and reduce technology-transfer timelines to support timely project delivery for its innovator customers.
The new pilot facility is designed to support flexible, cGMP-compliant scale-up across a wide range of chemistries. Its infrastructure includes reactors ranging from 20 litres to 2,000 litres, with stainless steel and glass-lined materials of construction as well as distillation and filtration through advanced equipment, including Hastelloy Agitated Nutsche Filter Dryers (ANFD) The facility also offers broad process capabilities, including cryogenic reactions, hydrogenation capabilities and high-temperature reactions and high-vacuum distillation capabilities. etc.
Commenting on the development, Sameer Hiremath, Vice Chairman and Managing Director of Hikal, said: “The commissioning of our cGMP pilot plant is an important step in strengthening Hikal’s pharmaceutical development and scale-up platform. It enhances our ability to support customers as they move from laboratory development to larger-scale, clinical development programmes, while staying anchored in quality, safety and compliance.”
The expansion reflects Hikal’s continued investment in research, development and manufacturing infrastructure to meet the evolving needs of global pharmaceutical customers while maintaining high standards of quality, safety and compliance.
