Product lifecycle management (PLM) for pharmaceuticals ties up considerable capacities in the quality and regulatory departments over the entire lifecycle of the marketing authorisation. Efficient management of information relevant for the authorisation of newly developed, reformulated and generic medicinal products is therefore a significant success factor. In particular, change notifications [...]

In recent years, we have strategically strengthened our presence in the future-oriented Asian market: we have entered into new distribution partnerships and participated in numerous trade fairs. Together with our Chinese partner Beijing Fengli, we are now exhibiting at CPHI 2024 in Shanghai, emphasising our commitment to this dynamic and [...]

The filing of two further dossiers with the Chinese NMPA* represents an outstanding milestone for customers in the Chinese market. From now on, manufacturers and exporters of finished pharmaceutical products can refer to these dossiers in their application documents. Our Regulatory Affairs department will issue your "Letter of Access" on [...]

The high quality that we strive for in our portfolio is also reflected in our service. One aspect of this service is to make the usage of our excipients as simple and safe as possible; hence, we have selected products certified by the "European Directorate for the Quality of Medicines [...]

Polymorphism is a fundamental phenomenon observed in lipid materials, encompassing a diverse group of biomolecules such as fats, oils, and phospholipids. This phenomenon refers to the ability of lipids to exist in multiple structurally distinct states of crystallinity. Polymorphism in lipid materials has significant implications, e.g. in pharmaceutical and industrial [...]

The topical therapy approach is the first choice for skin diseases. However, in order to ensure the intended therapeutic success, the patient’s cooperation is indispensable - especially in the case of chronic diseases. A pleasant skin feeling is the prerequisite for enabling the patient to use creams or ointments in [...]

IOI Oleo GmbH enjoys an excellent reputation worldwide as a manufacturer of high-quality, lipid-based additives. In order to ensure that we maintain our standards for the highest quality and to comply with the guideline values of national and international pharmacopoeias, we attach great importance to the selection of the raw [...]

The selection and qualification of a manufacturer of excipients and active ingredients is one of the main tasks of quality management, which aims, among other things, to ensure the manufacture of effective and safe pharmaceuticals. In this context, monographs serve as a guide to evaluate raw materials regarding their physico-chemical [...]