Drug Approval | October 18, 2023
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
The company does not expect the outcome of this inspection to impact its plans
Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy
The company has received marketing authorisation for docetaxel from Israel and cytarabine from Colombia
Five batches across four programs of Biocon Academy participated in the graduation ceremony
10+ emerging markets, Japan & ANZ transition in final phase
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