API Manufacturing

We offer 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.

Key Capabilities Include

  • Multi-stage synthesis with continuous cost improvement
  • Flexible Containment facility
  • cGMP multi-purpose pilot plants
  • Total reactor capacity of > 1200 KL
  • Micronization, filtration/drying, and continuous liner pack off capability
  • Capability to handle a range of reactions such as High temperature de-carboxylation, Enzymatic, Cryogenic, Cytoxic, Hydrogenation, Cyanation, Ozonolysis, Friedel-Crafts chemistry

API Services

Featured Services

Pre-Clinical Supply

We offer Pre-clinical API supply through our dedicated pre-clinical (pre-GMP) Kilo Labs, featuring capacities ranging from 50 to 100 liters

Clinical Supply

At Piramal, our flexible clinical 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 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.

 


 

Commercial Supply

Our commercial manufacturing capabilities are strategically distributed across various sites to ensure efficiency and flexibility in meeting diverse customer needs.

 

Scale-Up and Tech Transfer

At Piramal, we ensure a seamless transition for scale-up or facility changes through our tailored approach to technology transfer. With extensive experience and highly qualified experts, we integrate operational excellence into every aspect of the process. Our team assesses each project’s complexity to determine the appropriate transfer scope and strategy, while also addressing the expertise needed for an active pharmaceutical ingredient (API) technology transfer.

We combine solid technical proficiency, project management skills, commitment to innovation, regulatory knowledge, quality, compliance, adaptability, collaboration, continuous improvement, and efficiency to assure R&D professionals. Equipped with ongoing training and support, we facilitate smooth transitions across our manufacturing operations, including large-scale commercial cGMP production plants, pilot plants, and kilo laboratories. This commitment to excellence and comprehensive expertise ensures a streamlined technology transfer process, consistently supported across all Piramal sites.

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Shanghai, China - Sourcing Office

Associate Company of Piramal Pharma Ltd.

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