US FDA issues 17 observations for Biocon Biologics sites
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
The WAVEsystem with the WAVEcontrol 4.0 embedded
Syngene's collaboration with Zoetis started in 2011
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
National Institute of Biologicals should undertake the testing of more biologicals and also extend its testing expertise in helping other countries
Both manufacturing facilities are based out of Benguluru, India
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
The proposed transaction involves the sale of the global biosimilars portfolio of Viatris to Biocon Biologics
The two-year agreement will grant Lonza access to IBF's prominent network and allow IBF to benefit from Lonza's manufacturing expertise and knowledge in its due diligence review of potential targets
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