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Hikal commissions cGMP pilot plant at Pune research campus

#Infrastructure News#Industrial#India
Synopsis

Hikal Limited has commissioned an upgraded current Good Manufacturing Practice (cGMP)-compliant pilot plant at its Research & Technology campus in Pune to strengthen its pharmaceutical process development and manufacturing capabilities. The expanded facility is designed to support process development, scale-up, technology transfer and clinical-stage manufacturing for global pharmaceutical customers. Equipped with reactors ranging from 20 litres to 2,000 litres and advanced processing systems, the plant will enable the manufacture of preclinical and clinical-phase materials while facilitating a smoother transition from laboratory research to commercial production. The investment forms part of Hikal's strategy to expand its research and manufacturing infrastructure for regulated pharmaceutical markets.

Hikal Limited has commissioned an upgraded current Good Manufacturing Practice (cGMP)-compliant pilot plant at its Research & Technology (R&T) campus in Pune, strengthening its capabilities in pharmaceutical process development, scale-up, technology transfer and clinical-stage manufacturing. 
The enhanced facility, located within the company's Innovation Campus in Pune, has been developed to support pharmaceutical customers from the early stages of process development through to commercial manufacturing readiness. According to Hikal, the expanded infrastructure will enable closer integration between laboratory-scale research and large-scale production while supporting regulated development programmes. 
The pilot plant has been designed to facilitate process development, technology transfer and clinical-stage manufacturing in compliance with global quality and regulatory standards. It will also enable the production and supply of preclinical and clinical-phase development materials from the same research campus, allowing scientists and engineers to monitor projects more closely, improve collaboration and reduce technology transfer timelines. 
The upgraded facility incorporates flexible manufacturing infrastructure capable of supporting a broad range of chemical processes. It is equipped with stainless steel and glass-lined reactors ranging in capacity from 20 litres to 2,000 litres, along with distillation and filtration systems, including Hastelloy Agitated Nutsche Filter Dryers (ANFD). 
According to the company, the pilot plant is capable of handling cryogenic reactions, hydrogenation processes, high-temperature reactions and high-vacuum distillation, enabling it to support diverse pharmaceutical development requirements across multiple stages of product development. 
Commenting on the commissioning, Sameer Hiremath, Vice Chairman and Managing Director of Hikal, said the new cGMP pilot plant strengthens the company's pharmaceutical development platform by enhancing its ability to support customers as projects progress from laboratory research to larger-scale clinical development programmes. He added that the expansion reinforces Hikal's focus on quality, safety and regulatory compliance throughout the development process. 
The investment forms part of the company's ongoing efforts to expand its research, development and manufacturing infrastructure in response to the evolving requirements of global pharmaceutical companies. 
Established in 1988, Hikal manufactures active pharmaceutical ingredients, intermediates and biocides for the pharmaceutical, animal health, crop protection and specialty chemical industries. The company operates five manufacturing facilities across Maharashtra, Gujarat and Karnataka, alongside its Research & Technology centre in Pune. Its manufacturing sites have been inspected and certified by global regulatory authorities, and the company is among the first Indian life sciences firms to receive the Responsible Care® certification for its commitment to responsible manufacturing practices.

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