All operations are performed under the strictest environmental classifications from 100,000 to 100 at our facility in Louisville , KY. Our highly qualified team has more than 120 years of drug development experience.
Our facilities, procedures and records for the manufacture of pharmaceuticals are maintained in accordance with the FDA’s Current Good Manufacturing Practices. Every product is subjected to a stringent series of quality control evaluations to ensure purity, potency, identity and quality. All analytical methods are validated in accordance with FDA guidelines. All records are reviewed by our Quality Assurance Department and all documented procedures must be met before release.