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Results For "483"

187 News Found

NATCO Pharma API unit in Mekaguda receives EIR from USFDA
Drug Approval | July 24, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483


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


Briefs: Neuland Laboratories and Granules India
Drug Approval | June 29, 2025

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility


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


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 17, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation 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


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 13, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA