Trust and transparency – IMWITOR® 742 now with CEP

8. July 2024

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 for the active ingredients and excipients used can cause unforeseeable follow-up costs that are difficult to offset against the most competitive material prices.

The “Certification of Suitability to the monographs of the European Pharmacopoeia” (CEP) for excipients is not yet the standard, but offers the registering company enormous advantages.

 

This is why IOI Oleo GmbH recently applied for – and received – CEP 2.0 for its strategic growth product IMWITOR® 742. With this approval from the “European Directorate for the Quality of Medicines & HealthCare” (EDQM), interested companies can significantly simplify the registration processes for their finished medicinal products.

  • Simplified regulatory procedures: The registration of medicinal products with authorities is significantly simplified.

  • Highest quality standards: CEP certification confirms the excellent quality and purity of our product.

  • Time and cost savings: Less effort and lower costs in the creation and product life cycle management of the authorisation dossier

  • Global acceptance: CEP certification is accepted not only in Europe, but also by many international authorities.

  • Trust and transparency: A CEP-certified active ingredient or excipient offers companies and their customers a high degree of transparency and trust.

IMWITOR® 742 – The functional lipid for capsules and topicals

IMWITOR® 742 is already used as an active ingredient carrier, penetration enhancer and bioavailability booster in a wide variety of pharmaceutical formulations. In our article “IMWITOR® 742 – The penetration enhancer and bioavailability booster for your API“, we describe how the deliverability of active ingredients of BCS classes II-IV can be enabled or improved.

We are proud to be able to offer you this high-quality and certified product as a CEP variant in the future (“IMWITOR® 742 CEP 2021-199”). If you have any further questions, please contact us directly by e-mail (pharma@ioioleo.de) or get in touch with your usual contact person.

 

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Robert Radsziwill

Robert is the Business Development Manager for Functional Excipients in the Pharma Division of IOI Oleo GmbH. Prior to this role he held technical and commercial roles focusing raw materials used in the pharmaceutical and medical device industry for 13 years. In each position he leveraged his diploma degree in Business Chemistry earned at Westfälische Wilhelms-University to drive interdisciplinary projects and work as interface between commercial and technical decision makers. Understanding technical, commercial and regulatory drivers from ideation to successful project-completion is key for him. In his free time he enjoys guitar heavy music as well as cooking for and with family and friends.