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Challenges of control drug product development
OSD
Controlled drug substances
At Recipharm we have been supporting customers with their controlled substance projects for more than 25 years. Our state-of-the-art manufacturing facilities have the infrastructure to safely and securely handle potent materials and we are approved to import, store, manufacture and export Class 1–5 controlled substances.
Our expert team can support you in finding the most appropriate formulation and manufacturing process for your drug substance requirements, even for complex products, such as modified release or abuse deterrent formulations. We also have the experience to formulate cohesive, adhesive and electrostatic drug substances.
Our integrated offering means we can be your single source for controlled drug substance and product development through to commercial manufacture and packaging.
At Recipharm we offer
Development, testing and commercial manufacture of controlled substances
An established supply chain for import and export of drug substance and drug product within Europe and the USA
Storage of controlled substance products
Non-GMP and GMP capabilities
Various stages of clinical formulation development from Phase I to Phase III clinical studies
Supporting analytical chemistry development and stability studies
