Lupin Expands Oncology Manufacturing with New Vizag Facility
Filing Summary
Lupin Manufacturing Solutions, a subsidiary of Lupin Limited, has launched a dedicated oncology block at its Vizag facility in India. The new unit enhances the company’s capabilities in developing and manufacturing high potent active pharmaceutical ingredients (APIs) for oncology products. Spanning 4,270 square meters, the facility includes 20 reactors and advanced containment systems. This expansion supports the growing global demand for oncology drug development. The facility integrates process development and quality control laboratories, ensuring compliance with global standards. Lupin continues to strengthen its role as a global contract development and manufacturing organization (CDMO).
Lupin Manufacturing Solutions, a wholly owned subsidiary of Lupin Limited, has announced the commissioning of a dedicated oncology block at its Vizag facility in India. This new high-containment unit significantly enhances the company’s contract development and manufacturing capabilities for high potent active pharmaceutical ingredients (APIs) specifically for oncology products. The facility aims to support clients across the oncology development lifecycle, from preclinical research to commercial manufacturing.
The new facility spans 4,270 square meters and is equipped with 20 reactors ranging from 250L to 2000L. It includes over 20 isolators and advanced containment systems, ensuring exposure levels of ≤0.05 µg/m³. The design incorporates flexible scale-up capabilities with a batch range of 1–35 kg and comprehensive environmental controls, maintaining conditions of ≤25°C and ≤45% relative humidity. These features allow for the safe, efficient, and compliant production of oncology APIs that meet global quality standards.
The facility integrates a process development laboratory with a dedicated quality control laboratory. This integration enables early-stage route scouting, analytical development, process optimization, and validation within a single location. The facility is supported by scientists with specialized expertise in high potent APIs, ensuring a seamless transition from lab-scale synthesis to full-scale commercial manufacturing. It features advanced containment infrastructure, isolator-based operations at every process step, integrated SCADA systems, and a robust effluent detoxification system that complies with global regulatory standards.
The new oncology block is part of Lupin’s strategy to address the growing global demand for oncology drug development and manufacturing. By integrating Lupin’s scientific legacy with advanced containment facilities and regulatory excellence, Lupin Manufacturing Solutions provides a cohesive ecosystem that supports the development of oncology treatments from concept to commercialization. This expansion strengthens Lupin’s role as a trusted global contract development and manufacturing organization (CDMO) partner for oncology innovators.
The facility’s commissioning marks a significant milestone in Lupin Manufacturing Solutions’ evolution as a dedicated CDMO partner. The investment in the Vizag facility enables global clients to deliver oncology treatments more quickly while upholding the highest safety and compliance standards. The facility’s advanced capabilities are designed to meet the needs of clients at every phase of the oncology development lifecycle.
Lupin Limited is a global pharmaceutical leader specializing in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and focuses on multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.