The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
This is the second US FDA GMP inspection of this facility within one year
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
The audit was commenced for newly renovated manufacturing Block 1, Block 2, and Block 3
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The company increases its efficiency and is able to face the growing demand for its services.
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