PRNewsWire
10 Aug 2026, 00:00 UTC · 1d ago
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Mabwell's subsidiary T-mab passed the Brazilian Health Regulatory Agency's (ANVISA) GMP on-site inspection for its denosumab biosimilars 9MW0311 and 9MW0321. — Passing a rigorous inspection in Latin America's largest pharmaceutical market is a critical regulatory milestone that removes a major barrier to commercial entry.
+0.60The ANVISA certification serves as Mabwell's second GMP certification from a PIC/S member authority, facilitating potential access to other PIC/S member markets. — PIC/S alignment reduces regulatory friction for expanding the product's reach into multiple other global jurisdictions.
+0.40Mabwell has submitted market authorization applications for its denosumab products in eight countries, including Brazil, and has already secured approval in Pakistan. — This demonstrates a broad international commercialization strategy and provides a pipeline of pending approvals to monitor.
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The company successfully passed a rigorous Brazilian GMP inspection, paving the way for market entry in Latin America's largest economy.
The company successfully passed a rigorous Brazilian GMP inspection, paving the way for market entry in Latin America's largest economy.
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