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

 

The move marks a significant expansion of the company's pharmaceutical development and manufacturing capabilities.

 

The upgraded facility strengthens Hikal’s integrated platform across process development, scale-up, technology transfer and clinical-stage manufacturing, enabling the company to support global pharmaceutical customers from early-stage development through commercial manufacturing readiness.

 

Designed to bridge the gap between laboratory research and commercial production, the expanded pilot plant will help accelerate development timelines, improve process robustness and deliver high-quality materials for regulated development programmes. 

 

The facility enables the manufacture and supply of preclinical and clinical-phase development materials from the same R&T campus, allowing scientists and engineers to closely track processes, enhance collaboration and reduce technology-transfer timelines.

 

The cGMP-compliant facility is equipped to handle flexible scale-up across a broad range of chemistries. Its infrastructure includes reactors ranging from 20 litres to 2,000 litres, featuring stainless steel and glass-lined construction, along with advanced distillation and filtration systems, including Hastelloy Agitated Nutsche Filter Dryers (ANFD).

 

The pilot plant also supports specialised process capabilities, including cryogenic reactions, hydrogenation, high-temperature reactions and high-vacuum distillation, enabling Hikal to meet complex development and manufacturing requirements for innovator pharmaceutical companies.

 

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 underscores Hikal’s continued investment in research, development and manufacturing infrastructure as the company works to address the evolving needs of global pharmaceutical customers while maintaining stringent standards of quality, safety and regulatory compliance.