Mallinckrodt Pharmaceuticals offers responsive service to our customers by providing support materials and technical assistance from subject matter experts who work with controlled substances, drug chemicals, acetaminophen products and associated formulations every day. Our support team is always available to help you navigate the world’s evolving regulatory requirements and answer any technical questions you have before or after your API purchase.
- We have more than a century of experience working with regulatory agencies like the United States (US) Drug Enforcement Administration and the US Food and Drug Administration. Our extensive experience and deep understanding of international regulatory bodies keep us abreast of regulations around the world.
- Our subject matter experts partner with you, navigating regulatory challenges to get your products to market. When our customers develop and prepare regulatory submissions, our Research and Development and Regulatory Affairs departments provide support to accelerate the development process and improve the likelihood of regulatory approval.
Technical Support for Your Order
- When you begin working with Mallinckrodt’s API team, we provide you a complete technical package. The “Tech Packet” offers insights from our staff gained from years of experience working with APIs — including product technical data, applications and basic formulations — to assist you as you develop and manufacture your products.
- We also offer placebo samples for your performance evaluations and provide analytical research standards, which indicate the potential impurities and degradation products of your order.
- As an API supplier and finished product manufacturer, we offer expertise on how to solve formulation challenges. Customers benefit from our extensive knowledge of formulation characteristics for various dosage forms and technologies.
At Mallinckrodt, we continually strive to expand our current extensive knowledge of API regulations, products, excipients and impurity detection. We invest in continuous learning opportunities for our in-house experts, so they help you stay on the cutting edge of the industry and deliver the personal, on-demand service you need. We look forward to servicing your business as your supplier of choice.