Hikal commissions cGMP pilot plant in Pune to strengthen pharma capabilities

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Hikal Limited, a leading partner to global pharmaceutical, crop protection and specialty chemical companies, 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.