The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Boehringer Ingelheim aims to develop this program as a potential key centerpiece component for its immuno-oncology portfolio
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
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