This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies
The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs
Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Enables additional US manufacturing capacity to serve increased demand for pharma/biotech customers
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Commercial production is expected to begin soon
Extended lab space for product development, customer demos, and training
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
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