Purity with purpose: Clariant Health Care raises the bar for pharmaceutical excipients

MUTTENZ, September 15, 2026 - Excipients are the backbone of every drug formulation. Though often described as "inactive" ingredients, they determine how an active substance dissolves, stabilizes, and ultimately reaches the patient. As formulation complexity grows and regulatory scrutiny intensifies, the industry has moved well beyond asking whether an excipient meets specification. Formulators and quality assurance teams now demand clarity on impurity profiles, endotoxin levels, elemental impurities, nitrosamine risk, and batch-to-batch consistency.

Meeting these demands requires more than compliance, it requires a fundamentally different approach to excipient design. That is precisely the philosophy Clariant Health Care has built its entire excipient strategy around.

A tiered platform built on purposeful purity

Clariant's response to this elevated standard is the VitiPure platform, a tiered system engineered to align excipient quality with formulation need. The starting point is always the customer's challenge: which formulation, which application, which patient population? Quality follows from that answer.

VitiPure addresses standard pharmacopoeia-grade requirements. VitiPure Lex serves low-endotoxin applications such as injectables and vaccines. VitiPure Superior targets the most sensitive, stability-critical formulations where standard compliance is simply not enough. The platform is built on the conviction that two excipients meeting the same monograph specification can still perform very differently in a customer's formulation, and that true pharmaceutical purity must go further than any standard document can capture.

Setting a new standard for oncology injectables

A flagship expression of this philosophy is VitiPure CO 35 Superior, Clariant's premium PEG-35 castor oil developed specifically for oncology injectables. In formulations such as paclitaxel, where PEG-35 castor oil may account for more than 50% of excipient volume, even minor color variation can trigger regulatory scrutiny, delay batch release, and undermine patient confidence.

Through proprietary adsorbent technology, VitiPure CO 35 Superior achieves reduction in color intensity versus standard commercial grades, without compromising solubilization efficiency. The impact of this level of excipient quality extends directly to patients. A visually consistent, high-purity injectable does more than satisfy a regulatory requirement, it supports patient confidence and empowers healthcare providers to administer treatments that inspire trust. By engineering excipients with both compliance and the patient experience in mind, Clariant Health Care places people at the center of its formulation science.

Excipient performance means little without reliable supply

World-class excipient quality is only as valuable as its availability. Recognizing this, Clariant has reached a decisive operational milestone with the activation of its Clear Lake facility in Texas, the company's first U.S. site dedicated to pharmaceutical-grade PEG excipient manufacturing. Purpose-built and fully GMP-compliant, the facility is designed to meet the pharmaceutical industry's most rigorous quality, safety, and regulatory expectations, providing customers with the documentation, traceability, and quality assurance that regulated production demands. For North American and Latin American customers, regional manufacturing translates directly into shorter lead times, reduced inventory costs, and enhanced supply continuity.

"This expansion strengthens our ability to provide reliable local supply and positions us as a true partner to the North American pharmaceutical industry," said Vaios Barlas, Head of Health Care at Clariant. "At CPhI Milan, we look forward to showing customers what that partnership means in practice, from supply chain reliability to one of the most advanced excipient quality available on the market."

VitiPure^™ IS A TRADEMARK OF CLARIANT.

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