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From early-stage development to large-scale production
Lupin Manufacturing Solutions operates as a fully integrated platform, offering uncompromising quality at best-in-class cost. Our vertically integrated approach ensures streamlined processes from early-stage development to large-scale production, delivering efficiency and precision across all operations.
Early Phase – IND Enabling Services
In the early phase of drug development, LMS provides comprehensive Investigational New Drug (IND) enabling services. Our vertically integrated operations and efficient processes ensure smooth progression through initial research stages, enabling us to deliver high-yield outcomes while maintaining rigorous standards.
Late Phase – Clinical API Manufacturing
For late-phase drug development, LMS offers late-phase clinical and, validation API manufacturing services. Our commitment to high-yield production, combined with cutting-edge technology, ensures that we meet all commercial requirements and regulatory standards seamlessly.
Process Development & Analytical Development
Both our early and late-phase operations are supported by advanced process development and analytical development. By continually optimizing processes and improving yields, we ensure that products maintain consistent quality throughout the production cycle, while also enhancing efficiency and scalability.
Commercial – API Manufacturing and Technology Transfer
Our API manufacturing capabilities are bolstered by efficient technology transfer processes. Our right-sized plant capacity minimizes idle costs, while our world-class EHS systems ensure that safety, health, and environmental standards are maintained at the highest level. By leveraging our scale, we
offer attractive pricing for input purchases, ensuring our clients receive the best value without compromising quality.
Generics – Generic API Manufacturing, Intermediates & Raw Starting Materials
We are industry leaders in the manufacturing of generic APIs, intermediates, and raw starting materials. Our India-based manufacturing model offers significant cost savings, with overheads up to 80% lower than typical US pharmaceutical operations. This allows us to pass on the cost advantages to our clients with no compromise on product quality.
Regulatory Services
LMS offers comprehensive regulatory services, ensuring full compliance with international standards for all commercial and generics manufacturing processes. Our expertise enables our clients to navigate regulatory complexities with ease, ensuring timely market access and product success.