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2025-09-09 13:14:24

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Latest News
  • Glenmark Pharma arm receives upfront payment of $700 Mn from AbbVie
  • Embassy Developments' New Project 'Paradiso' in North Bengaluru Fully Sold Out with Topline of ~₹204 Cr
  • Bartronics India Ltd enters into MoU with RenewCred
  • RailTel Corporation of India Ltd receives LOA worth Rs. 262.14 crore
  • Arisinfra and Vaishnavi Residences Launch Arsh Greens, a community of Exclusive Villa Plots "within" the City of Bengaluru

Keywords Selected:  USFDA

Stock Report

  • USFDA conducts product specific pre-approval inspection at Lupin Ltd's Aurangabad facility
  • Closure of USFDA inspection at Zydus' injectable manufacturing plant at Jarod
  • U.S. FDA Completes Inspection at Biocon Biologics' Facility at Biocon Campus, Bengaluru, India
  • Caplin Steriles Ltd granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
  • Lupin receives U.S. FDA approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity
  • Apitoria Pharma Pvt Ltd receives 5 observations from USFDA for API facility
  • SMS Pharmaceuticals Ltd receives EIR from USFDA for Central Laboratory Analytical Services
  • Unichem Laboratories Ltd receives EIR from USFDA classifying Roha API facility as VAI
  • Gland Pharma receives approval for Vasopressin in 5% Dextrose RTU Injection
  • Alembic Pharmaceuticals Limited receives USFDA Final Approval for Macitentan Tablets, 10mg
  • Gland Pharma receives approval for Norepinephrine Bitartrate in 5% Dextrose Injection Bags
  • Gland Pharma receives approval from USFDA for Cangrelor for Injection 50 mg/vial
  • Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg
  • Zydus receives final approval from USFDA for Prucalopride Tablets, 1 mg and 2 mg
  • Senores Pharmaceuticals Ltd's material subsidiary reeceives 3 observations from USFDA for its facility
  • Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg
  • Lupin receives US FDA Approvals for Liraglutide and Glucagon Injectable Products
  • Zydus receives tentative approval from USFDA for Ibrutinib tablets 140 mg, 280 mg, and 420 mg
  • Lupin receives Form 483 with 3 observations from USFDA for Pithampur Unit-3
  • Lupin receives Form 483 with 4 observations from USFDA for Pithampur Unit-2
  • EIR from USFDA, for Shilpa Medicare Ltd. Unit VI, Bengaluru.
  • Biocon Biologics Expands Diabetes Portfolio with FDA Approval of Kirsty™
  • Zydus receives final approval from USFDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg
  • Emcure Pharmaceuticals Ltd successfully completes USFDA PAI of Oncology facility

Latest Post

  • Glenmark Pharma arm receives upfront payment of $700 Mn from AbbVie
  • Embassy Developments' New Project 'Paradiso' in North Bengaluru Fully Sold Out with Topline of ~₹204 Cr
  • Bartronics India Ltd enters into MoU with RenewCred
  • RailTel Corporation of India Ltd receives LOA worth Rs. 262.14 crore
  • Arisinfra and Vaishnavi Residences Launch Arsh Greens, a community of Exclusive Villa Plots "within" the City of Bengaluru


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