Nitrosamines Risk Mitigation

Excipients are a crucial component of the pharmaceutical product formulation, and the industry is constantly having to adapt to changes in demand and technology innovations

The new Center of Excellence “Closer to the Formulator” (C2F) by DFE Pharma helps pharmaceutical companies to shorten the time from a concept to a finished commercial product through expertise in all phases of pharmaceutical development. 

The services offered by this new state-of-the-art facility, are mainly focused on Oral Solid Dosage (OSD) forms, comprising all types of pre-registration work including development, intermediate scale-up, and technology transfer. 


 The C2F offerings can provide pharmaceutical companies with multiple advantages as, for example, it aims to significantly lower the number of development cycles and aspires to reduce formulation costs, when launching a medicine. 

As pharmaceutical production moves from batch-wise to continuous manufacturing, individual processing steps, such as blending of the active pharmaceutical ingredient (API) with excipients, have to be re-designed to continuous operations.

Whilst the cost and quality benefits of CM are well documented, successful implementation relies on an in-depth understanding of how raw materials and their mixtures – including excipients – behave in continuous processes. This whitepaper will outline some of the key learnings from DFE Pharma’s excipients in CM processes variability experiments, before setting out DFE Pharma’s Stretch Batch Approach and how it can work in practice.
Ultimately, it will demonstrate why DFE Pharma is fast becoming the pharma industry’s preferred global partner in the robust development of continuous tablet manufacturing processes.

DFE Pharma's Norten Hardenberg plant, located in Germany, is dedicated to the production of anhydrous lactose. An investment for the future, featuring a new state-of-the-art production line, like for like process, high-end control to ensure batch homogeneity.

DFE Pharma is a global leader in excipient products and services for usage in the pharmaceutical, biopharmaceutical, and nutraceutical industries. We strive to develop, produce and supply the highest quality functional excipients for oral solid dose, inhalation, and parenteral formulations. Our products play essential roles as fillers, binders, disintegrants, and stabilizing agents in formulations. 

They enable the active ingredients to be dosed and released into the patients' system in a predictable, accurate, and effective manner. With over a century of experience, we are driven by our purpose your medicines, our solutions. Moving to a healthier world. #pharma #DFEPharma #excipients