Cognis - Premium Quality Pharmaceutical Excipients

The Cognis Group, headquartered in Monheim, ranks among the world leaders in specialty chemicals. As a leading supplier of innovative specialty chemicals and nutritional ingredients, Cognis is renowned for top-quality environmentally-friendly products manufactured from natural raw materials, and for its dedication to science and education, technical expertise and innovative marketing solutions. Cognis has been successful in developing a significant number of naturally-derived products that are used as building blocks, excipients and drug delivery agents by the pharmaceutical industry.

In 2007, Cognis recorded sales of about 2.8 billion euros and an adjusted EBITDA (operating result) of 360 million euros. Cognis employs about 6,000 people, and it operates production sites and service centres in 30 countries.

Cognis nutrition and health

Health, and physical and spiritual well being in conjunction with convenience benefits are the main demands encountered in the wellness market. With natural-source ingredients and extensive know-how in relation to healthy nutrition, Cognis is able to provide products, formulations and marketing-oriented concepts for functional food, additives and dietary supplements.

The nutrition and health group has established four market segments through which to focus its products and services:

• Pharmaceuticals and healthcare
• Dietary supplements
• Functional food and medical nutrition
• Food technology

Natural-source ingredients for the pharmaceutical industry

Within the pharmaceuticals and healthcare market segment, Cognis offers an innovative product portfolio with a wide range:

• Excipients based on oleochemicals and derivatives (Pharmaline™)
• Chitosan (Chitopharm®): for topical and oral drug delivery and wound healing
• TPGS(Speziol TPGS Pharma): Drug delivery agent for poorly soluble drugs
• High-purity Azelaic Acid (Dermaz® Line), API grade
• Delios VF: MCT oil for parenteral application produced under ICH Q7-GMP

Pharmaline™ - product purity and process integrity

To meet the specific needs of the pharmaceutical industry for excipients complying with necessary IPEC-PQG regulatory requirements, Cognis has its PharmaLine™ product range.

This range of oleochemical-derived, pharma-grade excipients, such as specialty esters, fatty alcohols, ethoxylates, hard fats, stearic acids, mono- and triglycerides, castor oil derivatives, etc., is used by pharmaceutical companies in their topical, oral and parenteral formulations for different applications:

• Drug delivery agents
• Tableting aids
• Solubilizers
• Consistency factors
• Emulsifiers
• Emollients
• Cream bases
• Suppository masses
• Moisturisers
• Surfactants for solid, semi-solid and liquid pharmaceutical dosage forms

Product purity and process integrity are the pillars of the PharmaLine™ concept. PharmaLine™ products satisfy the most stringent requirements. Cognis PharmaLine™ products are excipients that comply with the latest Pharmacopeias.

Analyses according to the relevant monographs are performed on each manufacturing batch. Additionally extensive purity data (e.g. heavy metals, microbiology, aflatoxins, etc.) and US drug master files (Type IV) are available. Impeccable equipment and safety-conscious, highly-trained employees ensure compliance with all hygiene regulations. Through integrated management systems ISO 9001, ISO 14001, Cognis maintains its high quality standards.

Furthermore, the PharmaLine™ quality system defines in detail the manufacturing procedures for Cognis' excipients, and monitors compliance with the relevant Good Manufacturing Practice (GMP) guidelines according to International Pharmaceutical Excipients Council (IPEC).

The GMP standard guidelines cover the areas of industrial hygiene, production facilities, and methodologies and quality assurance procedures. Cognis' drumming facility, which complies with the GMP standard, obtained a conformity declaration to the IPEC-PQG GMP guideline.

Oleochemical derived premium quality excipients

It's a clear goal to constantly enlarge the list of PharmaLine™ products according to customers' needs. In addition Cognis is open to discuss tailor-made products and solutions for the pharmaceutical industry. This includes the development of liquid derivatives used as solubilising excipients for drug delivery purposes.