We offer API manufacturing services at lab, kilo, and pilot scales, catering to preclinical studies, all stages of clinical trials, and commercialization, providing quantities ranging from milligrams to kilograms.
With a successful track record of over 60 years, we manufacture and supply Active Pharmaceutical Ingredients (APIs) through our sites in North America, Europe, and Asia. Our API facilities are inspected and approved by global regulatory bodies, including the US FDA, Health Canada, Japan PMDA, and UK MHRA.
Recognized as the preferred partner for global big pharma and biotech companies, our total reactor volume exceeds 1200 KL (including pilot and multi-purpose plants). With a record of over 30 successful launches, we illustrate our capability to meet extensive small molecule API requirements.
We offer pre-clinical manufacturing services through our dedicated pre-clinical (pre-GMP) Kilo Labs, featuring capacities ranging from 50 to 100 liters.
At Piramal, our flexible clinical supply manufacturing services cater to the supply of drug substance materials for clinical trials. Our proficient operations team collaborates closely with process chemists and engineers, overseeing the process at the pilot manufacturing facility to ensure a seamless transition to later-phase clinical batches and commercial launch.
We produce and provide Active Pharmaceutical Ingredients (APIs) for Phase I to Phase III trials at our facilities across North America, Europe, and Asia.
Our commercial API manufacturing capabilities are strategically distributed across various sites to ensure efficiency and flexibility in meeting diverse customer needs.
At Piramal, we provide a smooth and efficient transition for scale-up or facility changes through our customized approach to API Tech Transfer. With years of experience and a team of highly skilled experts, we integrate operational excellence into every stage of the process. Our team evaluates the complexity of each project to define the best transfer strategy and scope, ensuring the necessary expertise is in place for a successful active pharmaceutical ingredient (API) tech transfer.
We blend technical expertise, project management capabilities, a commitment to innovation, regulatory insight, and a focus on quality, compliance, and continuous improvement. Our ongoing support and training ensure a seamless transition across our manufacturing operations, from large-scale commercial cGMP production plants to pilot plants and kilo laboratories. This comprehensive approach guarantees a streamlined, efficient tech transfer process at all Piramal sites.
Shanghai, China -
Sourcing Office
Associate Company of
Piramal Pharma Ltd.
