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Results For "observations"

259 News Found

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
News | August 27, 2025

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations


Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr
News | August 08, 2025

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025


Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product


Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA
Drug Approval | July 06, 2025

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations


SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


USFDA concludes inspection of NATCO’s  Pharma Division, Kothur
Drug Approval | June 20, 2025

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483


Briefs: Hikal and Sun Pharma
Drug Approval | June 17, 2025

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility


USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations