### Clariant Enthusiastically Unveils Novel Health Care Products at CPHI India 2024
Clariant is thrilled to showcase its newest array of healthcare products at the upcoming CPHI India exhibition in Delhi NCR from November 26 to 28, 2024. This year’s presentation will highlight Clariant Health Care’s locally produced “Made in India” offerings, their Bonthapally facility operations, and their expertise in biologics, generics, and excipient manufacturing. The array features dependable, premium, economical, and customized solutions tailored for India’s expanding healthcare sector.
“By harnessing India’s manufacturing prowess, we enhance the global pharma market with our high-purity excipients. Our domestically-produced items are crucial to the pharmaceutical industry’s commitment to optimizing drug formulation and delivery, as well as improving patient outcomes. Simultaneously, we strive to uphold top-tier industry compliance,” remarks Vaios Barlas, Clariant’s global head of healthcare.
Excipients play a crucial role in the stability, bioavailability, and efficacy of active pharmaceutical ingredients (APIs). The global excipients market is projected to grow at a compound annual growth rate (CAGR) of 6 to 7%, fueled by the surge in demand for specialty drugs and biologics, stringent regulatory norms, and the rising needs of aging populations worldwide.
For seamless ultra-pure excipient supply, Clariant couples international expertise from Clariant International Ltd (Switzerland) with local manufacturing strength in India, offering tailored solutions to meet the evolving needs of the pharmaceutical industry. India has become a global pharma leader, contributing over 50% of worldwide vaccines and 40% of generic medications.
“Our clientele values high-quality goods that support local economies. Clariant’s Indian manufacturing operations address the unique requirements of Indian and regional markets while also meeting global standards mandated by the FDA, EMA, and other regulatory bodies. This makes us a preferred associate in developing biologics, injectables, and intricate drug formulations,” says Bhushan Thekedar, head of global business development, Health Care.
Bonthapally facility’s parenteral excipients are produced in advanced clean room environments, complying with rigorous international sterility and purity standards to ensure excipient efficacy and safety. Local production of essential excipients like VitiPure Superior and Meglumine maintains a critical role in bolstering the global healthcare supply chain.
At the event, Clariant plans to introduce forward-thinking pharmaceutical products applicable to sensitive API, parenteral formulations, oral, and topical agents.
Clariant introduces a solution line with VitiPure LEX 3350 S, VitiPure LEX 4000 S, and Polyglykol 1450 S to overcome API delivery and bioavailability hurdles.
The VitiPure LEX range, characterized by low endotoxin levels, is crafted for clients needing precise microbial regulation in their formulations. These co-solvents are optimized for sensitive uses and safe for various APIs, even those with low water solubility.
VitiPure LEX 3350 S and VitiPure LEX 4000 S exceed typical pharmacopoeia standards and have undergone risk assessments for parenteral excipient applications. Apart from standard monograph requisites, specific microbiological certifications have been achieved.
Polyglykol 1450 S, an alternative polyethylene glycol co-solvent, meets the current USP-NF monograph and complies with FDA-recommended monoethylene and diethylene glycol limits. Produced under IPEC GMP in flake form, it eases handling in production, surpassing current international pharmacopeia guidelines.
VitiPure CO 35 Superior (Polyoxyl 35 Castor Oil), VitiPure O 80 Superior (Polysorbate 80), and VitiPure L 20 Superior (Polysorbate 20) will debut for colorless and parenteral applications requiring ultra-pure excipients.
The VitiPure Superior line offers colorless excipients, ensuring no pigmentation in the final formulation due to ultra-low residual impurities. Ideal for APIs sensitive to impurities, these products are designed for formulations needing low microbial and endotoxin levels, suitable for parenteral use. VitiPure CO 35 Superior caters to applications demanding the highest excipient purity, while VitiPure O 80 Superior and VitiPure L 20 Superior stabilize human and veterinary vaccines and biologics.
Compared to standard grades, the Superior products better stabilize finished API formulations. The steel packaging with nitrogen purging minimizes peroxide formation during storage.
VitiPure Meglumine LEX for sensitive formulations is a novel solubilizer for those requiring low bioburden and low endotoxin grades. Appropriate as a counter-ion in contrast media, a buffering agent, and a solubilizer for mildly acidic APIs, it is suitable for parenteral applications.
VitiPure HCO is a micronized hydrogenated castor oil (HCO) for solid oral and topical formulations.
VitiPure HCO serves tablet formulations as a lubricant or sustained-release agent and functions as a consistency factor for topical formulations. Its consistent particle size is perfect for tablet lubrication where a hydrophobic lubricant is needed or as a magnesium stearate alternative, compatible with direct compression or dry granulation manufacturing.