Regulatory innovations – Milestones for the Chinese market – IMWITOR® 742, MIGYLOL® 810 N & MIGLYOL® 812 N
30. January 2024
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 request.
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. Read in our article how IMWITOR® 742 can enable or improve the deliverability of active ingredients of BCS classes II-IV. These properties are the reason for extensive and global interest and the need for equally global regulatory support. The submitted dossier includes applications for all dosage forms except injectables, ophthalmic agents and inhalation products.
MIGLYOL® 810 N & MIGLYOL® 812 N – Versatile Excipients
The use of MIGLYOL® 810 N and MIGLYOL® 812 N as excipients, emollients and penetration enhancers has long been well-established, for example for capsules, semi-solid and oral liquid forms. The dossier submitted includes applications for all dosage forms except injectables, ophthalmic agents and inhalation products.
MIGLYOL® 812 N – Active ingredient
The benchmark in the MCT sector in terms of quality and regulatory support. The first choice among the leading providers of injectables or for parenteral nutrition (More about this in the article: “MIGLYOL® as the worldwide benchmark for injectables”). Manufactured under clean room conditions and already successfully present on the Chinese market for several years with our local partner Feng Li.
Did you know?
IMWITOR® 742 and MIGLYOL® products show excellent stability against thermal and oxidative stress, are made from plant-based, renewable raw materials and can be supplied sustainably, certified according to the Mass Balance principles of the RSPO!!!
Conclusion:
The granting of the registration numbers has created the basis for market access and product use in the Chinese growth market. This underlines IOI Oleo GmbH’s global commitment, high quality management standards and regulatory expertise.
Please contact us for further information on these materials and the associated “Letter of Access”!
NMPA*: the highest administrative agency for the regulation of medicines, medical devices and cosmetics for the Chinese market
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.
