Benuvia Operations Achieves GMP Certification for Pharmaceuticals
Benuvia Operations Secures GMP Certification from ANVISA
In an important development for the pharmaceutical manufacturing sector, Benuvia Operations, LLC has announced its recent acquisition of Good Manufacturing Practices (GMP) certification from Brazil's National Health Surveillance Agency, commonly known as ANVISA. This achievement signifies Benuvia's commitment to delivering exceptional pharmaceutical manufacturing services tailored to the needs of both Brazilian and international clients.
strategic Commitment to Quality Manufacturing
The CEO of Benuvia, Terry Novak, expressed great pride in the team’s efforts in achieving this certification. "This certification underlines our strategic approach to providing top-tier pharmaceutical manufacturing that is not only compliant but also finely attuned to Brazil's burgeoning healthcare landscape," Novak stated. The certification, known in Portuguese as Certificado de Boas Práticas de Fabricação (CBPF), positions Benuvia as a preferred manufacturing partner for companies eager to enter or expand in Brazil's significant healthcare market.
Importance of ANVISA CBPF Certification
GMP certification from ANVISA is a crucial requirement for any pharmaceutical enterprise looking to produce and disseminate products within Brazil, Latin America's largest healthcare market. Companies earning this certification must adhere to stringent local manufacturing regulations, ensuring quality and safety during the production process. The certification allows Benuvia Operations to manufacture non-sterile liquid pharmaceutical products, a capability that is vital for both local and international pharmaceutical companies seeking compliant production options in Brazil.
Provider of Rapid Market Entry Solutions
With the newfound certification, Benuvia is in an excellent position. It opens doors for companies that need a manufacturing partner that offers reduced regulatory challenges and quicker market entry. According to Novak, this builds credibility with healthcare providers and regulatory agencies, making Benuvia a reliable choice for pharmaceutical manufacturers.
About Benuvia Operations, LLC
Benuvia Operations, LLC operates as a global Contract Development and Manufacturing Organization (CDMO). The company specializes in delivering life-changing therapies to patients by providing comprehensive development and manufacturing services. With a focus on Active Pharmaceutical Ingredients (APIs) and finished dosage forms, Benuvia has expertise that extends into specific domains, including cannabinoids and psychedelics. The organization maintains a cutting-edge 83,000 square foot manufacturing facility in Round Rock, Texas, capable of producing Schedule I-V compounds. Benuvia handles everything from API synthesis and clinical trial supplies to commercial production, catering to every phase of the drug development lifecycle.
Exceptional Manufacturing Facility
Benuvia's manufacturing facility stands out due to its advanced capabilities and dedication to meeting rigorous standards in production. This high-quality approach to manufacturing ensures that products are not only effective but also compliant with safety regulations, maintaining the trust of healthcare providers and patients alike.
Frequently Asked Questions
What is GMP certification?
GMP certification signifies that a manufacturing facility follows strict quality assurance and control processes, ensuring products are consistently produced according to quality standards.
Why is ANVISA important for pharmaceutical companies?
ANVISA oversees the regulatory framework for health products in Brazil, ensuring safety, efficacy, and quality, which is crucial for companies wanting to operate within the country.
How does Benuvia support pharmaceutical companies?
Benuvia provides a range of services from development to manufacturing, helping pharmaceutical companies bring products to market efficiently while ensuring compliance with regulations.
What types of products can Benuvia manufacture?
Benuvia specializes in non-sterile liquid pharmaceutical products, as well as managing various regulated substances, ensuring quality and safety in production.
Where is Benuvia located?
Benuvia Operations has its state-of-the-art manufacturing facility located in Round Rock, Texas, designed to uphold high standards in pharmaceutical production.
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