Drug Approval | March 09, 2026
Lupin receives two observations from USFDA for Ankleshwar facility
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY
Inspection included drug device combinations covering our recent filing in nasal sprays domain
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry
Coverage has been significantly strengthened across key therapeutic categories, including anti-tubercular, anti-diabetic and anti-cancer medicines, as well as iron supplements, thereby ensuring more comprehensive standardisation of medicines used under various National Health Programmes
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