Benuvia Operations Granted GMP Certification from Brazil National Health Surveillance Agency (ANVISA)
Company becomes preferred manufacturing partner for Brazilian and international pharmaceutical companies launching or expanding in Latin America's largest healthcare market
ROUND ROCK, Texas, March 12, 2025 /PRNewswire/ -- Benuvia Operations, LLC, a global contract development and manufacturing organization, today announced that it has received a Good Manufacturing Practices (GMP) certification (Certificado de Boas Práticas de Fabricação or CBPF) from Brazil's National Health Surveillance Agency (ANVISA).
"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. 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," stated Terry Novak, CEO of Benuvia.
ANVISA's CBPF certification is an essential regulatory prerequisite for pharmaceutical companies to manufacture and distribute pharmaceutical products within Brazil, the largest healthcare market in Latin America. Companies that receive ANVISA CBPF certification are required to meet rigorous local manufacturing standards. This certification enables Benuvia to produce non-sterile liquid pharmaceutical products for local and international pharmaceutical companies seeking compliant and high-quality production capabilities within the Brazilian pharmaceutical market.
Mr. Novak continued, "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."
About Benuvia Operations, LLC
Benuvia Operations, LLC is a global Contract Development and Manufacturing Organization (CDMO) that helps pharmaceutical, and biotech companies deliver life-changing therapies to patients in need. The company provides end-to-end development and manufacturing services for Active Pharmaceutical Ingredients (APIs) and finished dosage products and has extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can produce Schedule I-V compounds, offering comprehensive solutions for companies throughout the entire drug development lifecycle—from API synthesis and clinical trial supply to commercial production. Learn more at www.benuvia.com.
Forward-Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "anticipate", "believe", "could", "estimate", "upcoming", "expect", "intend", "may", "plan", "predict", "project", "will" and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. These forward-looking statements should be considered together with the risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
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SOURCE Benuvia Operations, LLC