CORONA Remedies receives EU-GMP certification for hormone facility
Accreditations for Bhayla manufacturing site strengthen the company’s global quality credentials and support expansion of its hormone portfolio into regulated international markets
Accreditations for Bhayla manufacturing site strengthen the company’s global quality credentials and support expansion of its hormone portfolio into regulated international markets
Anti-GD2 monoclonal antibody for high-risk neuroblastoma advances toward BLA submission following successful tech transfer from California to Bengaluru
This certification confirms that the facility complies with Good Manufacturing Practice requirements as referred in the EC Directive
The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
PMDA is regarded among the most stringent regulatory bodies globally
Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms
This certification paves the way for CORONA's entry into five EAEU member nations- Russia, Kyrgyzstan, Armenia, Belarus, and Kazakhstan-under a B2B business model
The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products
Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates
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