The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Good momentum in commercial CDMO business
The net profit in the June quarter was also lower than Rs 146.3 crore reported in the March quarter.
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
Pfizer will make upfront and milestone payments, as well as pay royalties on sales of resulting therapeutics
KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026
CMOs showed an increasing reluctance to take on debt in 2022
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