News | June 24, 2024
EMA approves Biocon Biologics’ new mAbs facility in India
Renews GMP certifications for India and Malaysia sites
Renews GMP certifications for India and Malaysia sites
Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
This new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades.
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
It will enable the company to branch out to new geographies and strengthen its presence in South Africa
Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution, as there is no need for freezer storage
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