The Opioid Analgesic REMS program mandates that pharmaceutical companies implement rigorous safety protocols for outpatient medications, including educational outreach for healthcare providers and standardized patient guidance. By recording zero inspectional observations, KVK-Tech demonstrated that its current manufacturing and distribution systems align with these federal safety requirements.

Anthony Tabasso, CEO of KVK-Tech, noted that the result reinforces the company’s internal focus on regulatory compliance. This latest audit follows a successful 2025 review of the company’s Adverse Drug Events reporting processes. Founded in 2004, the Pennsylvania-based manufacturer continues to maintain its entire production line within the United States, supplying generic alternatives to major pharmacy chains and wholesalers nationwide.