The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The CRL did not identify any outstanding scientific issues with the product.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
India has the second-largest number of adults with diabetes globally, after China
Aims to increase compliance and improve outcomes for People with Diabetes (PwD)
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
Go-ahead for pivotal clinical trial which is expected to commence by March
MJ will be paid a one-time lumpsum licence fee of Rs 15 crore
BRIDGE-1 Comprehensive care programme for Type 1 diabetes and to train 400 physicians and benefit over 1000 children
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