OSD
Controlled drug oral solid dose (OSD) manufacturing
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 controlled drug substance offering
Our controlled drug substance offering allows us to assist you in a range of areas:
- Controlled substances expertise - support in the national and international logistics of controlled substances and controlled drug products
- Clinical manufacturing support - across various clinical manufacturing stages, from Phase I to Phase III studies
- Commercial manufacturing – proven capabilities in the manufacturing of controlled products
- Compliant supply chains - support with import and export within Europe and the USA
- Secure storage - for controlled substance products
- Regulatory expertise - in both non-GMP and GMP standards
- Analytical services - including method development, method validation, dissolution studies, stability studies, release analytic, elemental impurities, nitrosamine analytic and more.
Related services
- Technology transfer support in seamless transition of data, materials and knowledge
- Analytical services comprehensive support for a range of analytical development services
- Regulatory delivering regulatory excellence for customers across the globe
- Product development helping customers create a stable and bioavailable drug product that meets their desired QTPP
Partner with Recipharm for your controlled drug substance manufacturing
Need assistance with manufacturing your OSD controlled drug substance? Recipharm is your trusted CDMO partner to help navigate the complex demands of controlled substance import, storage and manufacturing. Contact us for support with all your clinical to commercial needs.
