Hikal Limited, a partner to global pharmaceutical, crop protection and specialty chemical companies, commissioned an enhanced current Good Manufacturing Practice (cGMP) compliant pilot facility at its Research & Technology (R&T) Campus in Pune. The new facility strengthens the company’s pharmaceutical development, process scale-up and clinical manufacturing capabilities, enabling it to better support global innovator companies from early-stage research through commercial manufacturing readiness. The investment further reinforces Hikal’s commitment to expanding its contract development and manufacturing (CDMO) capabilities while meeting stringent international quality and regulatory standards.
New Facility Strengthens End-to-End Pharmaceutical Development
The upgraded cGMP pilot facility bridges the gap between laboratory research and commercial-scale manufacturing. By integrating process development, technology transfer and clinical-stage manufacturing at a single location, Hikal aims to accelerate drug development programmes and improve operational efficiency.
The facility enables customers to accelerate pharmaceutical development timelines, improve process robustness and scalability, produce high-quality materials for regulated development programmes, simplify technology transfer from laboratory to manufacturing and reduce project execution timelines. The facility allows scientists and engineers to manufacture and supply both preclinical and clinical-stage development materials directly from the Pune R&T campus, promoting closer collaboration and faster decision-making throughout the product development lifecycle.
Advanced Infrastructure Supports Diverse Chemistries
Designed for flexible and cGMP-compliant scale-up, the facility supports a broad spectrum of pharmaceutical manufacturing processes. Its advanced infrastructure includes reactors ranging from 20 litres to 2,000 litres, stainless steel and glass-lined reactors, advanced distillation and filtration systems, Hastelloy Agitated Nutsche Filter Dryers (ANFDs) and high-vacuum distillation equipment. In addition, the facility is equipped to handle complex chemical processes such as cryogenic reactions, hydrogenation, high-temperature reactions and high vacuum distillation. These capabilities enable Hikal to support a wide range of active pharmaceutical ingredient (API) development and scale-up requirements for global pharmaceutical innovators.
Supporting Clinical-Stage Manufacturing
The enhanced facility has been designed to support clinical-stage manufacturing while complying with global regulatory and quality requirements. By producing development materials within the same research campus, Hikal can closely monitor process performance, facilitate seamless technology transfer and ensure consistent product quality throughout the development cycle. As a result, pharmaceutical customers can transition more efficiently from laboratory-scale research to clinical production and eventual commercial manufacturing.
Leadership Highlights
Sameer Hiremath, Vice Chairman and Managing Director of Hikal, said the investment marks an important milestone in strengthening the company’s pharmaceutical development platform. He noted that the cGMP pilot plant enhances Hikal’s ability to support customers as they progress from laboratory research to larger-scale clinical development programmes while maintaining the highest standards of quality, safety and regulatory compliance.
Strengthening Hikal’s Global CDMO Capabilities
The commissioning of the cGMP pilot plant reflects Hikal’s continued investment in research, development and advanced manufacturing infrastructure. As pharmaceutical companies increasingly seek integrated development and manufacturing partners, the expanded facility positions Hikal to deliver end-to-end solutions spanning process development, scale-up, technology transfer and clinical manufacturing. As per the press release, by combining advanced infrastructure with strong regulatory compliance and technical expertise, Hikal is further strengthening its role as a trusted global partner for pharmaceutical innovation and commercialisation.
