Vantage Secures FDA Drug Master File for VYCERIN™ API Glycerin, Enhancing Pharmaceutical Formulation Options
Key Insights
Vantage Specialty Chemicals (search) has successfully listed its VYCERIN (search)™ API Glycerin, USP on the FDA Drug Master File (DMF-040171), offering a first-to-market pharmaceutical-grade glycerin manufactured in the United States to ICH Q7 standards.
The product enables pharmaceutical manufacturers to use glycerin as an active ingredient without relying on atypical API exceptions, while providing benefits including enhanced stability, bioavailability, and efficacy in various drug formulations.
Derived from sustainable vegetable oils, VYCERIN (search)™ API Glycerin can be utilized in both prescription and OTC products, serving multiple functions including as a penetration enhancer, solubilizer, and skin protectant.
Vantage Specialty Chemicals (search), Inc. announced today that its VYCERIN (search)™ API Glycerin, USP has been officially listed on the Drug Master File (DMF-040171) with the U.S. Food and Drug Administration (search) (FDA). This represents a significant development for pharmaceutical manufacturers seeking domestically produced active pharmaceutical ingredients that meet stringent quality standards.
The company describes VYCERIN (search)™ as the first-to-market API grade glycerin specifically manufactured and packaged in the United States according to ICH Q7 standards, designed to address evolving pharmaceutical formulation requirements.
Strategic Importance for Pharmaceutical Formulations
"With our VYCERIN (search) API portfolio, we empower customers to utilize glycerin as an active ingredient without relying on atypical API exceptions," said Tom Giese, Executive Vice President, Performance Solutions at Vantage. "This multifunctional compound significantly enhances the stability, bioavailability, and efficacy of numerous pharmaceutical formulations."
Giese highlighted the supply chain advantages of the product, noting that Vantage addresses "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."
Product Applications and Technical Benefits
VYCERIN (search)™ API Glycerin, USP is derived from sustainable vegetable oils and can be incorporated into a wide range of pharmaceutical products. According to Vantage, the ingredient is suitable for both prescription (Rx) and over-the-counter (OTC) drug products, including:
- Skin protectants
- Lip treatments
- Hemorrhoid creams
- Suppositories
The company emphasizes that VYCERIN (search)™ features an exceptionally low impurity profile, which can reduce undesirable component interactions in formulations. This characteristic, combined with its versatility, allows the ingredient to function as a:
- Penetration enhancer
- Solubilizer
- Osmotic agent
- Viscosity modifier
- Skin protectant
- Tonicity modifier
Manufacturing Capabilities and Expertise
Vantage brings over three decades of experience as the leading manufacturer of glycerin in the United States. The company operates a world-scale oleochemical facility in Chicago, Illinois, and a manufacturing site in Englewood, Ohio, both registered as FDA API facilities.
These manufacturing operations are supported by what the company describes as "a robust team of regulatory and quality experts" that enable local auditing capabilities and agile innovation processes for drug product manufacturers.
Significance of the Drug Master File
The Drug Master File provides the FDA with comprehensive information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storage of VYCERIN (search)™ API Glycerin, USP.
This regulatory filing creates a streamlined pathway for pharmaceutical manufacturers who incorporate VYCERIN (search)™ into their product formulations. These companies can now easily reference the DMF when updating formulations or filing various applications with the FDA, including:
- Investigational New Drug (IND) applications
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
The establishment of this Drug Master File represents Vantage's commitment to supporting pharmaceutical innovation while addressing industry needs for domestically produced, high-quality active pharmaceutical ingredients.