The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore
The submission is supported by positive results from the Phase 3 AMPLIFY trial
These filings come after FDA issued its latest warning to patients and healthcare professionals about the serious dangers of compounded GLP-1 drugs
During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Granules India receives 1 observation from USFDA for Chantilly facility
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