The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
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
SMS Pharmaceuticals has reported total income of Rs. 165.81 crores during the quarter ended June 30, 2024
Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Q1 FY25 revenues up 20% YoY to Rs. 1,002 crore
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
The acquisition will further strengthen Barentz’ position in India creating a leading life science distribution platform
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
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