Pharmaceutical Oils

One particular challenge in working with plant-based pharmaceutical ingredients is the variability of the raw materials themselves. Vegetable products can differ greatly from region to region, supplier to supplier, and even month to month.

However, because these variations can have a significant impact on how the final product performs, physical and chemical stability is crucial. For more information, see Managing the natural variability of plant-based pharmaceutical ingredients.

To resolve this, ADM chooses to source the very best raw materials. Further, we are leading several initiatives to guarantee the quality of our products:

• Select suppliers working with specific crop cultivars
• Select a particular sourcing period over the year, to guarantee specific characteristics
• Collaborate with our suppliers to improve their extraction processes
• Target oils with different origins, as needed to achieve a specific fatty acid profile
• Select suppliers with dedicated production lines to avoid cross contamination
• Engage in regular audits of suppliers

We work together with our suppliers to achieve our common goals of quality and consistency.

Recognized for our expertise in oils and fats, ADM continues to master the most advanced analytical techniques in compliance with Good Laboratory Practices (GLP). We ensure our materials and products are thoroughly tested at every phase of design and production to ensure quality.

Process management is of major importance in handling the variability of naturally derived pharmaceutical ingredients. In order to achieve batch-to-batch consistency for both excipients and APIs, we carefully implement In-Process Controls and use the appropriate tools to immediately identify any deviations in design or production.

Finally, ADM has been involved in extending global knowledge by proposing new and innovative methods of analysis for purified pharmaceutical oils. We have been rewarded by the US Pharmacopeia for our contributions to numerous programs, including fully revising the monographs on olive oil and soybean oil. Our quality professionals are also involved with the European Pharmacopoeia Commission on fatty oils and derivatives, bringing their gained knowledge and experience.

We offer sophisticated technological knowledge as well as recognized experience and leadership in the chemistry of pharmaceutical oils.

With a range of technologies and many practical capabilities, ADM specializes in small and medium batch production that can be customized to your requirements. Such batches are delivered with full source traceability, guaranteed.

Following the rules and guidelines of Good Manufacturing Practices (GMP), our custom refining process requires deep process knowledge, but the result is the expert removal of impurities and volatile components. What’s left behind are purified pharmaceutical oils that comply with the world’s highest quality standards.

All of our activities have led us to gain substantial knowledge of regulatory requirements in the fields of pharmaceuticals, food, and cosmetics. To guarantee compliance with the highest standards, we ensure both the standardization and the constant evolution of our products.

Our regulatory service oversees the tasks necessary to keep our products in compliance with all appropriate regulations. As well, they have submitted and manage pharmaceutical regulatory files (Active Substance Master File – ASMF) in Europe, India, and the US. With the experience gained from this, our regulatory team contributes strongly to the development of our business activities.

We comply with the highest standards as a matter of course, giving us the ability to meet our customers’ regulatory requirements in oil-based solutions. We go above and beyond both specifications and expectations.