Clariant Health Care launches VitiPure Superior and U.S. PEG facility
- Clariant’s VitiPure platform is tiered to match excipient quality to formulation need, with VitiPure Lex for low‑endotoxin injectables and VitiPure Superior for stability‑critical formulations.
- VitiPure CO 35 Superior is a PEG‑35 castor oil formulated for oncology injectables; proprietary adsorbent tech reduces color intensity while preserving solubilization performance.
- Clariant activated its Clear Lake, Texas facility as the company’s first U.S. site dedicated to pharmaceutical‑grade PEG excipient manufacturing, GMP‑compliant and purpose‑built for pharma documentation and traceability.
- Clariant will present its full Health Care excipient portfolio at CPhI Milan 2026, Booth 1D104.
Context
Regulatory and formulation demands mean excipients must be characterised beyond monograph compliance: impurity profiles, endotoxin and elemental limits, nitrosamine risk, and batch‑to‑batch consistency are now critical for formulators and QA teams.
VitiPure platform
Clariant’s VitiPure is a tiered excipient platform designed to align quality with application. VitiPure addresses standard pharmacopoeia requirements, VitiPure Lex targets low‑endotoxin uses such as injectables and vaccines, and VitiPure Superior is aimed at the most sensitivity‑ and stability‑critical formulations.
Flagship product
VitiPure CO 35 Superior, a premium PEG‑35 castor oil for oncology injectables, reduces color intensity via proprietary adsorbent technology while maintaining solubilization efficiency. The grade targets formulations where PEG‑35 castor oil can represent a majority of excipient volume and where visual consistency affects batch release and end‑user confidence.
Manufacturing and supply
Clariant has activated a purpose‑built, fully GMP‑compliant facility in Clear Lake, Texas, its first U.S. site for pharmaceutical‑grade PEG excipient manufacture. The site provides documentation, traceability and quality assurance intended to shorten lead times, reduce inventory costs and improve supply continuity for North and Latin American customers.
Where to see it
Clariant Health Care will exhibit its excipient portfolio at CPhI Milan 2026, Booth 1D104.
Source: Clariant