Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India
This addition highlights our commitment to meeting market needs and providing high-quality over the-counter solutions for our customers
The clinical trial will be conducted at 19 sites with 10,335 participants across India
EBITDA for Q1 FY25 is at Rs. 100 crore compared to Rs. 32 crore in the previous year
Dr. Vinod Kumar Paul highlighted the huge gap between the demand for and supply of organs
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
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
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
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