Mabwell Passes Brazilian GMP Inspection for Denosumab Injections
Biopharmaceutical company Mabwell announced its subsidiary T-mab has passed a GMP inspection by Brazil's health authority ANVISA for its denosumab injections. This marks the company's second PIC/S GMP certification.
Shanghai-based biopharmaceutical firm Mabwell (688062.SH, 02493.HK) has received approval from Brazil's National Health Surveillance Agency (ANVISA) for the manufacturing of its denosumab injections. T-mab, a wholly-owned subsidiary of Mabwell, successfully passed ANVISA's Good Manufacturing Practice (GMP) on-site inspection, which verifies drug manufacturing quality standards.
The approval covers Mabwell's production processes for denosumab injections. Denosumab is a monoclonal antibody used to treat conditions such as osteoporosis and cancer. Obtaining GMP certification from ANVISA in Brazil represents the company's second such international accreditation, following its prior PIC/S GMP certification.
ANVISA's GMP inspection is stringent, and passing it indicates that Mabwell's manufacturing practices adhere to international quality and safety benchmarks. This achievement is expected to facilitate market expansion for Mabwell's denosumab products within South America.
Mabwell continues to focus on global market presence by advancing its research and development pipeline and ensuring product quality through international regulatory compliance.