OSD
Navigating the complex realm of controlled substance formulation and manufacturing demands expertise.
Our state-of-the-art manufacturing facilities, equipped with cutting-edge infrastructure, are designed to handle controlled substances securely. As an organisation approved to import, store, manufacture, and export Class 1–5 controlled substances, we stand as your trusted partner in the intricate landscape of controlled drug manufacturing.
In our GMP Product development labs and in our Tech-Transfer centers we can support with all relevant oral solid technologies at clinical and commercial scale.
Recipharm’s comprehensive offerings
Our controlled drug substance offering allows us to assist you in a range of areas:
- Expertise and support in the national and international logisitics of controlled substances and controlled drug products
- Support across various clinical manufacturing stages, from Phase I to Phase III studies
- Commercial manufacturing of controlled products
- Support with implementing a compliant supply chain for import and export within Europe and the USA
- Storage capabilities for controlled substance products
- Expertise in both non-GMP and GMP standards
- Comprehensive support in analytical services such as method development, method validation, dissolution studies, stability studies, release analytic, elemental impurities, nitrosamine analytic and more.
Do you need assistance with controlled substance manufacturing?
Find out more about how Recipharm can deliver value with your projects.