Benuvia Operations Achieves GMP Certification from Brazil's ANVISA

Benuvia Operations, LLC, a prominent global contract development and manufacturing organization, has recently secured Good Manufacturing Practices (GMP) certification from the National Health Surveillance Agency of Brazil (ANVISA). This milestone underscores Benuvia's unwavering dedication to meeting the rigorous standards set by one of the leading health authorities in Latin America and amplifies its capacity to serve both local and international pharmaceutical companies engaged in this growing market.

A Step Forward for Pharmaceutical Manufacturing

The certification, known as Certificado de Boas Práticas de Fabricação (CBPF), is a critical regulatory requirement for pharmaceutical companies looking to manufacture and distribute their products within Brazil. By achieving this status, Benuvia is positioned to provide top-tier, compliant manufacturing services tailored to the demands of Brazil's burgeoning healthcare landscape. The certification positions Benuvia as a reliable partner capable of producing non-sterile liquid pharmaceutical products for various stakeholders in the industry.

CEO Terry Novak expressed pride in the team's efforts, stating, "Achieving ANVISA's CBPF certification reflects our strategic commitment to delivering high-quality pharmaceutical manufacturing specifically designed for Brazil's rapidly evolving healthcare market. Our team's dedication has been exceptional, allowing us to meet ANVISA's stringent criteria, and establishing us as a trustworthy manufacturing partner for pharmaceutical companies across Brazil."

Unlocking Market Access and Enhancing Credibility

The successful acquisition of ANVISA's CBPF certification not only facilitates Benuvia's market entry but also reduces regulatory hurdles for pharmaceutical companies looking to expand in Brazil, the largest healthcare market in Latin America. Companies certified by ANVISA must adhere to stringent manufacturing protocols, a requirement that enhances their credibility among regulatory bodies, healthcare providers, and customers alike.

Mr. Novak elaborates on this strategic advantage, stating, "This certification allows us to become the preferred provider for firms seeking a partner that can expedite market entry and navigate the complex regulatory environment with ease. This not only strengthens our position but also enhances our perceived credibility in the eyes of potential customers and partners."

About Benuvia Operations, LLC

Benuvia Operations, LLC is a leading Contract Development and Manufacturing Organization (CDMO) that supports pharmaceutical and biotech companies in delivering transformative therapies to patients. Known for its extensive experience with cannabinoids, psychedelics, and controlled substances, Benuvia provides comprehensive development and manufacturing services for active pharmaceutical ingredients (APIs) as well as finished dosage products. The company's state-of-the-art manufacturing facility in Round Rock, Texas, spans 83,000 square feet and is equipped to produce Schedule I-V compounds, offering robust solutions that cover the entire drug development lifecycle—from API synthesis and clinical trial supply to commercial production.

In summary, Benuvia Operations' certification from ANVISA represents a significant advancement in its ability to serve the pharmaceutical sector in Brazil. As Benuvia continues to fortify its presence in the global healthcare space, the company remains committed to delivering high-quality solutions and fostering relationships with partners across the industry.