Drug Approval | July 30, 2024
Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Dr. Reddy's Laboratories has reported total income of Rs. 7,672.7 crores during the period ended June 30, 2024
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Acquisition in line with Mankind’s stated objective to expand its presence in high entry barrier complex portfolios and high potential OTX brands
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
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