Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency

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The global contract development and manufacturing organization Benuvia Operations announced on March 11, 2025 that it received a good manufacturing practice (GMP) certification (Certificado de Boas Práticas de Fabricação, CBPF) from Brazil’s National Health Surveillance Agency (ANVISA) (1). Such certification is essential, Benuvia said in a press release, as a regulatory prerequisite for pharmaceutical companies to manufacture and distribute products in Brazil.

Benuvia, based in Round Rock, Tx., provides end-to-end development and manufacturing services for APIs and finished dosage products, and has specific experience in cannabinoids, psychedelics, and other controlled substances, according to information provided in the release (1).

“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,” Terry Novak, Benuvia CEO, said in the release (1). “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.”

The standards alluded to by Novak, if and when met, allow Benuvia to produce non-sterile, liquid pharmaceutical products for both local and international companies that are seeking compliant, high-quality production capabilities within the Brazilian market, according to the press release (1).

“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,” Novak added.

As part of its coverage of CPHI Milan 2024, Pharmaceutical Technology® spoke with Rafael Ferrer, interim chief business officer at Acino, about expansion into emerging markets, a conversation in which Ferrer used Brazil—albeit the largest current market in Latin America—as an example when talking about navigating the regulatory landscape in places to where the drug pipeline does not always extend (2).

“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], right?” Ferrer said in the interview (2). “So, we have to take that into consideration ... to understand what are the pathways of getting new drugs, new medicines, to market across those markets.”

Brazil was also mentioned by BridgeBio Pharma, of Palo Alto, Calif., in its Feb. 12, 2025 announcement that the European Union had granted marketing authorization for its Beyonttra (acoramidis), a treatment for wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (3). At the time, BridgeBio said that the treatment, the first of its kind to be approved with a label specifying a near-complete (≥90%) transthyretin stabilizer, was also under review by both the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency.

Click here for Pharmaceutical Technology®’s full interview with Rafael Ferrer from CPHI Milan 2024.

References

1. Benuvia. Benuvia Operations Granted GMP Certification from Brazil National Health Surveillance Agency (ANVISA). Press Release. March 11, 2025.
2. Lavery, P. CPHI Milan 2024: Pharma Developments in Emerging Markets. PharmTech.com, Oct. 10, 2024.
3. BridgeBio Pharma. Beyonttra (acoramidis), The First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM. Press Release. Feb. 11, 2025.