The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
Both departments will be equipped with specialized professionals and state-of-the-art facilities ensuring the highest standards of care
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Revolutionary technology will further boost OneSource’s scientific services offerings
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Acquisition in line with Mankind’s stated objective to expand its presence in high entry barrier complex portfolios and high potential OTX brands
The partnership will significantly advance their sustainability initiatives by meeting around 67% of their power requirements for these plants
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
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