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The worldwide contract improvement and manufacturing group Benuvia Operations introduced on March 11, 2025 that it acquired manufacturing follow (GMP) certification (Certificado de Boas Práticas de Fabricação, CBPF) from Brazil’s Nationwide Well being Surveillance Company (ANVISA) (1). Such certification is important, Benuvia stated in a press launch, as a regulatory prerequisite for pharmaceutical firms to fabricate and distribute merchandise in Brazil.
Benuvia, primarily based in Spherical Rock, Tx., gives end-to-end improvement and manufacturing companies for APIs and completed dosage merchandise, and has particular expertise in cannabinoids, psychedelics, and different managed substances, in keeping with info offered within the launch (1).
“Reaching ANVISA’s CBPF certification underscores Benuvia’s strategic dedication to offering high-quality, compliant pharmaceutical manufacturing particularly tailor-made to Brazil’s quickly rising healthcare market,” Terry Novak, Benuvia CEO, stated within the launch (1). “I’m extremely pleased with our workforce’s distinctive dedication and onerous work in assembly ANVISA’s stringent requirements, positioning us as a trusted manufacturing companion for pharmaceutical firms in Brazil.”
The requirements alluded to by Novak, if and when met, enable Benuvia to supply non-sterile, liquid pharmaceutical merchandise for each native and worldwide firms which can be searching for compliant, high-quality manufacturing capabilities inside the Brazilian market, in keeping with the press launch (1).
“ANVISA CBPF certification permits us to be the popular supplier for firms searching for a companion with faster market entry, lowered regulatory hurdles, and stronger credibility amongst regulatory our bodies, healthcare suppliers, and pharmaceutical clients,” Novak added.
As a part of its protection of CPHI Milan 2024, Pharmaceutical Know-how® spoke with Rafael Ferrer, interim chief enterprise officer at Acino, about growth into rising markets, a dialog during which Ferrer used Brazil—albeit the biggest present market in Latin America—for example when speaking about navigating the regulatory panorama in locations to the place the drug pipeline doesn’t all the time prolong (2).
“The regulatory complexities and realities of Brazil will not be the identical as these of South Africa or those in Kuwait or the UAE [United Arab Emirates], proper?” Ferrer stated within the interview (2). “So, we have now to take that into consideration … to know what are the pathways of getting new medication, new medicines, to market throughout these markets.”
Brazil was additionally talked about by BridgeBio Pharma, of Palo Alto, Calif., in its Feb. 12, 2025 announcement that the European Union had granted advertising and marketing authorization for its Beyonttra (acoramidis), a remedy for wild-type or variant transthyretin amyloidosis in grownup sufferers with cardiomyopathy (3). On the time, BridgeBio stated that the remedy, the primary of its type to be authorised with a label specifying a near-complete (≥90%) transthyretin stabilizer, was additionally beneath assessment by each the Japanese Prescription drugs and Medical Units Company and the Brazilian Well being Regulatory Company.
Click on right here for Pharmaceutical Know-how®’s full interview with Rafael Ferrer from CPHI Milan 2024.
References
1. Benuvia. Benuvia Operations Granted GMP Certification from Brazil Nationwide Well being Surveillance Company (ANVISA). Press Launch. March 11, 2025.
2. Lavery, P. CPHI Milan 2024: Pharma Developments in Rising Markets. PharmTech.com, Oct. 10, 2024.
3. BridgeBio Pharma. Beyonttra (acoramidis), The First Close to Full TTR Stabilizer (≥90%), Accredited by the European Fee to Deal with ATTR-CM. Press Launch. Feb. 11, 2025.
