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 inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
The construction projects, which have already begun, will be finalised gradually from the end of 2027 through 202
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
The enhancements will improve environmental sustainability, strengthen material governance, and boost utility reliability
Inspection included drug device combinations covering our recent filing in nasal sprays domain
The Tanuku facility will focus on the production of key therapeutic APIs, including Anti-Tussive, Anti-Coagulant (Blood Thinner), Anaesthetic, and Antidepressant molecules
The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants
New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
Supports production of AbbVie's current and next-generation immunology and neuroscience medicines
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