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US FDA
8 articles
Several Indian pharmaceutical companies have recently faced scrutiny from the US Food and Drug Administration, though outcomes varied. Emcure, Aurobindo Pharma, and Alkem Laboratories received Form 483 observations following FDA inspections, indicating potential procedural or quality-related concerns. Piramal Pharma and Solara Active Pharma Sciences also received observations, though classified as Voluntary Action Indicated (VAI). Notably, Alkem Laboratories' Taloja facility cleared inspection without observations, and Lupin reported strong Q4 FY26 results, including US FDA approval for Glycerol Phenylbutyrate and a strategic focus on complex generics and biosimilars.
FDC Limited Receives US FDA ANDA Approval for Cefixime
FDC Limited received US FDA approval for its Abbreviated New Drug Application for Cefixime for Oral Suspension.
The approval covers two dosage strengths: 100 mg/5 mL and 200 mg/5 mL formulations.
This
Emcure Receives 7 US FDA Observations at Sanand Facility
Emcure Pharmaceuticals discloses US FDA inspection results at its Sanand formulations facility from May 6-15, 2026.
The inspection concluded with a Form 483 containing 7 observations, described as pro
Piramal Pharma US FDA Inspection Gets 3 VAI Observations
US FDA conducted a GMP inspection at Piramal Pharma's Sellersville facility from May 4-8, 2026.
The inspection concluded with a Form-483 containing three observations classified as Voluntary Action In
Alkem Taloja CRO Facility Clears US FDA Inspection
Alkem Laboratories reports an unannounced US FDA inspection at its Taloja, Maharashtra CRO facility on May 8, 2026.
The inspection concluded without the issuance of any Form 483 observations by the US
Lupin Q4 FY26 Net Profit Jumps 89% YoY
Lupin reported Q4 FY26 net sales of ₹73,919 crore, up 32.9% YoY, with net income surging 89% to ₹14,604 crore.
EBITDA margin expanded to 29.4% driven by strong US sales growth and operational efficien
Aurobindo Pharma Unit-VII Receives FDA VAI Classification
Aurobindo Pharma discloses US FDA's Voluntary Action Indicated (VAI) classification for its Unit-VII oral solid dosage facility.
The FDA inspection from January 28 to February 10, 2026, resulted in 9
Lupin Receives US FDA Approval for Glycerol Phenylbutyrate
Lupin Limited receives US FDA approval for its Abbreviated New Drug Application for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.
The approved product is bioequivalent to Ravicti® Oral Liquid
Alkem Laboratories Receives 7 US FDA Observations
Alkem Laboratories received Form 483 with seven observations after US FDA inspection at its Amaliya, Daman facility.
The inspection was conducted from April 20, 2026 to May 1, 2026 at the company's ma