Benuvia Operations, LLC, a global contract development and manufacturing organization (CDMO) based in Round Rock, Texas, announced on March 11, 2025, that it has received Good Manufacturing Practices (GMP) certification from Brazil's National Health Surveillance Agency (ANVISA). This certification, known locally as Certificado de Boas Práticas de Fabricação (CBPF), represents a critical regulatory milestone that allows the company to manufacture and distribute pharmaceutical products in Brazil.
"Achieving ANVISA's CBPF certification underscores Benuvia's strategic commitment to providing high-quality, compliant pharmaceutical manufacturing specifically tailored to Brazil's rapidly growing healthcare market," said Terry Novak, CEO of Benuvia. "I'm incredibly proud of our team's exceptional dedication and hard work in meeting ANVISA's stringent standards, positioning us as a trusted manufacturing partner for pharmaceutical companies in Brazil."
Strategic Importance for Brazilian Market Access
The ANVISA certification is a mandatory regulatory prerequisite for pharmaceutical companies seeking to manufacture and distribute products within Brazil, which represents the largest healthcare market in Latin America. Companies must meet rigorous local manufacturing standards to receive this certification.
With this approval, Benuvia is now authorized to produce non-sterile liquid pharmaceutical products for both local and international pharmaceutical companies looking for compliant, high-quality production capabilities within the Brazilian market.
Novak emphasized the competitive advantage this certification provides: "ANVISA CBPF certification allows us to be the preferred provider for companies seeking a partner with quicker market entry, reduced regulatory hurdles, and stronger credibility among regulatory bodies, healthcare providers, and pharmaceutical customers."
Specialized Manufacturing Capabilities
Benuvia Operations provides end-to-end development and manufacturing services for Active Pharmaceutical Ingredients (APIs) and finished dosage products. The company has developed particular expertise in cannabinoids, psychedelics, and other controlled substances.
The company operates an 83,000 square foot manufacturing facility in Round Rock, Texas, capable of producing Schedule I-V compounds. This facility offers comprehensive solutions throughout the entire drug development lifecycle, from API synthesis and clinical trial supply to commercial production.
Navigating Brazil's Regulatory Landscape
Brazil's regulatory environment presents unique challenges for pharmaceutical companies. As Rafael Ferrer, interim chief business officer at Acino, noted in a recent interview with Pharmaceutical Technology®, "The regulatory complexities and realities of Brazil are not the same as those of South Africa or the ones in Kuwait or the UAE [United Arab Emirates]."
Understanding these distinct regulatory pathways is crucial for companies looking to introduce new medicines to the Brazilian market. Benuvia's achievement of ANVISA certification demonstrates the company's ability to successfully navigate these complex requirements.
Growing Interest in Brazilian Market
Brazil continues to attract significant interest from international pharmaceutical companies. In February 2025, BridgeBio Pharma announced that its treatment Beyonttra (acoramidis) for transthyretin amyloidosis with cardiomyopathy was under review by the Brazilian Health Regulatory Agency, alongside submissions to regulatory bodies in Japan and the European Union (where it has since received approval).
Benuvia's new certification positions the company to support such international pharmaceutical companies in their efforts to enter or expand within the Brazilian market, offering manufacturing capabilities that meet local regulatory requirements.
Market Expansion Strategy
For Benuvia, this certification represents a key component of its international growth strategy, allowing it to serve as a manufacturing partner for companies targeting Latin America's largest healthcare market.
The certification process required Benuvia to demonstrate compliance with ANVISA's stringent manufacturing standards, which cover facilities, equipment, processes, and quality control systems. Successfully meeting these requirements indicates Benuvia's commitment to maintaining high-quality pharmaceutical manufacturing operations.
As pharmaceutical companies increasingly look to expand their global footprint, partners like Benuvia with established regulatory credentials in key markets can provide valuable support in navigating regional requirements and accelerating time to market.
