Deerfield, Illinois, February 10, 2024 (GLOBE NEWSWIRE) -- Vantage Specialty Chemicals, Inc. (‘Vantage’), today announced that its VYCERIN™ API Glycerin, USP is listed on the Drug Master File (DMF-040171) with the U.S. Food and Drug Administration (FDA). This first-to-market active pharmaceutical ingredient (API) grade glycerin is manufactured and packaged in the United States to ICH Q7 standards and is designed to meet the evolving needs of the pharmaceutical market.
“With our VYCERIN API portfolio, we empower customers to utilize glycerin as an active ingredient without relying on atypical API exceptions. This multifunctional compound significantly enhances the stability, bioavailability, and efficacy of numerous pharmaceutical formulations,” said Tom Giese, Executive Vice President, Performance Solutions. “Additionally, we address supply chain transparency challenges by providing a U.S. manufacturing source and an in-house team of technical and regulatory experts to support our customers’ formulation requirements.”
Derived from sustainable vegetable oils, VYCERIN API Glycerin, USP may be used in a wide variety of prescription (Rx) and over-the-counter (OTC) drug products including skin protectants, lip treatments, hemorrhoid creams, and suppositories. Its exceptionally low impurity profile can reduce undesirable component interactions and add versatility to formulations. Its diverse functional benefits may allow VYCERIN API Glycerin, USP to serve as a penetration enhancer, solubilizer, osmotic agent, viscosity modifier, skin protectant, and tonicity modifier.
With more than 30 years of experience, Vantage is the leading manufacturer of glycerin in the U.S. Our world-scale oleochemical facility in Chicago, IL and manufacturing site in Englewood, OH, are FDA-registered API facilities that are supported by a robust team of regulatory and quality experts to enable local auditing and agility of innovation for drug product manufacturers.
About Drug Master Files (DMF)
The DMF provides the FDA with detailed information about the facilities and processes or articles used in the manufacturing, processing, packaging and storing of VYCERIN API Glycerin, USP. Pharmaceutical manufacturers who integrate VYCERIN API Glycerin, USP into their product formulations can easily reference these important details when updating formulations or filing Investigational New Drug (IND), New Drug (NDA) and Abbreviated New Drug (ANDA) applications with the FDA.
About Vantage
Vantage provides natural solutions that support our customers’ technical performance and marketing needs through a unique combination of chemistry, application expertise and service. Underpinned by a broad portfolio of formulations, ingredients and actives that are built on a backbone of sustainable oils, fats and their derivatives, Vantage targets selected markets and applications including personal care, food, surface treatment, agriculture, pharma, and consumer and industrial performance. Vantage is headquartered in Deerfield, IL, operates in 11 countries worldwide and employs more than 1,000 talented professionals focused on delivering exceptional customer experiences with every interaction. Learn more at vantagegrp.com | vantagepharma.com
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Media Contact:
Louise Adhikari, Vice President, Communications & Public Affairs
Email: louise.adhikari@vantagegrp.com Phone: +1 312 863 0798