Engineered Lipid Excellence – Made in Germany

1. March 2021

IOI Oleo GmbH has not only been known for high quality excipients and active ingredients for pharmaceutical products for more than five years now. Products of the highest quality for the pharmaceutical, cosmetic, food and technical applications sectors have been developed and produced at our production site in Witten since the 1950s.

Hardly any other area today is as highly regulated by the legislature as the pharmaceutical industry. However, there are currently no manufacturing guidelines for lipid-based excipients, although most drugs consist for the largest part (75 to 99%) of excipients (source – German: Pharmazeutische Zeitung).

The team of the Pharma Business Unit at IOI Oleo GmbH is aware of its responsibility as a globally known provider of oleochemical specialties for pharmaceuticals. We were the first company to receive a GMP certificate for our excipients, although this is only required for active ingredients.

One of the world’s best-known products that meets these high standards is our MIGLYOL® 812 N. In addition to GMP certification, this product has a CEP certificate (Certificate of Suitability of Monographs of the European Pharmacopoeia) and is listed as a US drug Master File, Type II (No. 27975). In addition, MIGLYOL® 812 N is OU Kosher and Halal certified.

In addition, like the majority of our products, it is made from natural, renewable raw materials. Sustainability is part of our daily activities, which is why not only the entire IOI Group is RSPO (Round Table of Sustainable Palm Oil) certified, but is also one of the co-founders of this organization.

We operate the production facility of IOI Oleo GmbH in Witten under GMP guidelines, which is regularly checked by the German Health Authority. Due to the fact that some of our excipients are used in interdisciplinary areas such as cosmeceuticals or neutraceuticals, as well as our worldwide presence, we also follow other regulations and standards:

  • ISO 9001 & ISO 45001

  • EMAS

  • RSPO SCCS

  • EU GMP certified

  • US FDA registered

  • HACCP

  • Halal / Kosher

  • Cosmos/Ecocert

We are never satisfied with the status quo and ensure the continuous improvement of our products, our knowledge and our systems. Several major investments have already been made such as:

+ Ultrapure process water is created on site by means of reverse osmosis, ion exchange and UV treatment.

+ The pastillation of WITEPSOL® hard fats is performed in a class D cleanroom environment, finalized by a fully automatic packaging process.

+ In 2019 we completed a new building for filling in API quality. The new facility features a Class D cleanroom with automated filling procedures and packaging handling.

IOI Oleo GmbH strives for excellence in all of our activities – for our customers, our employees and our environment. If you would like to find out more about us, our products and production sites, we look forward to your message!

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Michael Plum

Michael Plum has been a member of our Pharma team since 1989. As Application Engineer, he is in close contact with our global industrial customers. With his background of more than 30 years of experience in the industry, he is a competent contact partner for any technical, regulatory or formulation related questions in the context of IOI’s pharmaceutical excipients. As an experienced and passionate home brewer, Michael Plum attaches great importance on the quality of his homemade products. He applies this setting on the technical related customer’s requests also in order to provide best support to our valued customers.

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