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US FDA
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Recent FDA actions highlight a mixed regulatory landscape for Indian pharmaceutical companies in the US market. Lupin received approval for its generic Pitolisant Tablets, bolstering its CNS portfolio, while Aurobindo faces both positive and negative developments: its Raleigh plant achieved Voluntary Action Indicated (VAI) status after addressing Form 483 observations, yet a separate subsidiary, Eugia Pharma, received a Warning Letter for a formulation facility. Neuland Laboratories also received a Form 483, indicating procedural improvements are needed. Despite these challenges, Rubicon Research’s strong Q1 performance, including acquiring a US manufacturing facility and resolving prior FDA inspections, demonstrates the potential for growth and margin expansion within the sector, suggesting that proactive compliance and strategic investments remain crucial for navigating the evolving regulatory environment.
Shilpa Medicare US Drug Recall 27,923 Vials
Shilpa Medicare voluntarily recalls 27,923 vials of Pemetrexed Injection in US due to atypical discoloration.
Recall classified as FDA Class II hospital-level recall covering 4 batches of chemotherapy
Lupin Receives US FDA Approval for Pitolisant Tablets
Lupin received final FDA approval for its generic Pitolisant Tablets in 4.45 mg and 17.8 mg strengths.
The approval confirms bioequivalence to Wakix® for all indications in the approved labeling.
This
Aurobindo Pharma US FDA Raleigh Plant VAI Classification
Aurobindo Pharma's US subsidiary Aurolife Pharma received VAI classification from US FDA for its Raleigh plant after March-April 2025 inspection.
The facility received 11 observations in Form 483 but
Neuland Laboratories Receives US FDA Form 483
Neuland Laboratories discloses US FDA inspection of its Unit 3 facility from August 10-14, 2026.
US FDA issued a Form 483 with one observation on procedural water and environmental monitoring improvem
Rubicon Q1 Revenue Up 51.6% YoY, PAT Jumps 95.8%
Q1 FY27 revenue grew 51.6% YoY to ₹5,343 Mn with PAT surging 95.8% to ₹848 Mn, driven by a broad-based portfolio.
Operating EBITDA margin expanded to 24.2% despite cost pressures, with the company upg
Aurobindo Pharma Unit Gets US FDA Warning Letter
Eugia Pharma Specialities Ltd, a wholly-owned subsidiary of Aurobindo Pharma, received a US FDA Warning Letter for its Unit I formulation manufacturing facility.
The facility contributes approximately