Hikal Limited, a leading partner to global pharmaceutical, crop protection and specialty chemical companies, has commissioned an enhanced current Good Manufacturing Practice (cGMP)-compliant pilot plant at its Research & Technology (R&T) campus in Pune.

The move reinforces its capabilities in pharmaceutical process development, scale-up, technology transfer and clinical-stage manufacturing.

The expansion strengthens Hikal's integrated pharmaceutical development platform, enabling the company to support innovator customers from early-stage process development through clinical manufacturing and commercial manufacturing readiness.

The upgraded pilot plant is designed to bridge laboratory-scale research with commercial-scale production while meeting global quality and regulatory standards. 

The facility will support process development, technology transfer and the manufacture of preclinical and clinical-phase development materials, helping customers accelerate development timelines, improve process robustness and generate high-quality materials for regulated development programmes.

By integrating research scientists and manufacturing engineers at the same Innovation Campus, the facility is expected to improve cross-functional collaboration, enable closer process monitoring and significantly reduce technology transfer timelines.

The pilot plant has been designed to support flexible, cGMP-compliant scale-up across a broad range of chemical processes. It features reactors ranging from 20 litres to 2,000 litres, including both stainless steel and glass-lined systems, along with advanced distillation and filtration equipment such as Hastelloy Agitated Nutsche Filter Dryers (ANFDs).

The facility also offers specialized process capabilities, including cryogenic reactions, hydrogenation, high-temperature reactions and high-vacuum distillation, allowing it to cater to complex pharmaceutical development requirements.

Sameer Hiremath, Vice Chairman and Managing Director, Hikal Limited, 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."