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2025-10-05 04:26:23

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Latest News
  • HDFC Bank Limited - Business Updates for Q2 FY2026
  • Hindustan Copper Ltd executes Kendadih mining lease deed
  • Bajaj Finance Limited - Q2 FY 2025-26 Business Updates
  • Kranti Industries Ltd inks MOU with KORES Group for JV
  • AU Small Finance Bank Limited - Performance Update for Q2 FY26

Keywords Selected:  USFDA

Stock Report

  • FDC Ltd receives USFDA approval for ANDA Pilocarpine Hydrochloride Ophthalmic Solutions
  • Synbiotics Ltd's Amphotericin B Manufacturing Facility receives USFDA approval
  • Sentynl Therapeutics updates on its NDA for CUTX-101
  • Wockhardt Submits New Drug Application to U.S. FDA for Zidebactam-Cefepime for Treatment of Serious GramNegative Infections
  • Lupin receives approval from U.S. FDA for Rivaroxaban for Oral Suspension
  • Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Paroxetine Extended Release Tablets USP, 25 mg and 37.5 mg.
  • Zydus receives EIR for the oncology injectable manufacturing facility in SEZ1, Ahmedabad
  • Jubilant Pharmova announces Completion of Pharmacovigilance Inspection by the USFDA with No Observations
  • Lupin gets 4 observations from USFDA from PAI at Pune Biotech facility
  • USFDA successfully completes inspection at Indoco's API manufacturing facility at Patalganga with zero observations
  • Lupin receives approval from U.S. FDA for Lenalidomide Capsules
  • Lupin receives 6 observations from USFDA for Nagpur Injectable facility
  • Alembic Pharmaceuticals Ltd receives EIR from USFDA for facility at Panelav
  • Update on US FDA Inspection at Sun Pharma Halol Facility
  • Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe
  • 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

Latest Post

  • HDFC Bank Limited - Business Updates for Q2 FY2026
  • Hindustan Copper Ltd executes Kendadih mining lease deed
  • Bajaj Finance Limited - Q2 FY 2025-26 Business Updates
  • Kranti Industries Ltd inks MOU with KORES Group for JV
  • AU Small Finance Bank Limited - Performance Update for Q2 FY26


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