Search result for 'oai'

USFDA issues Form 483 with 4 observations to Lupin's Pithampur Unit-2 facility after inspection. Company working to resolve issues.

Sun Pharma is working to resolve USFDA compliance issues at three facilities: Halol, Mohali, and Dadra. The company is implementing CAPA and anticipates mid to high single-digit growth in FY26.

The Indian Pharmaceutical Alliance refutes a study claiming Indian generic drugs have higher adverse events, stating quality is not region-dependent and meets global standards.

Indoco Remedies received a warning letter from the USFDA for its Goa manufacturing plant after failing to meet compliance standards. The company is working to resolve the issues.

Zydus Lifesciences receives a warning letter from the USFDA for its injectables manufacturing facility in Jarod, Gujarat, due to violations of manufacturing regulations. The letter does not mention...

Aurobindo Pharma's Eugia Pharma Specialities Ltd received a warning letter from the USFDA for its formulations manufacturing unit in Telangana. The company assures no impact on existing US supplies.

USFDA has issued an 'Official Action Indicated' classification for Zydus Lifesciences's injectables plant in Gujarat, indicating potential regulatory action.

USFDA classifies Zydus Lifesciences' Jarod injectables facility as 'Official Action Indicated' following inspection. Learn about the implications and what it means for the company.

Sun Pharma has received a warning letter from the USFDA for its Dadra facility due to violations of manufacturing norms. The USFDA's warning letter outlines violations of Current Good Manufacturing...