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Results For "observations"

251 News Found

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
News | September 20, 2021

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily


Solara announces closure of US FDA inspection at Puducherry facility
Drug Approval | April 30, 2026

Solara announces closure of US FDA inspection at Puducherry facility

The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets


Energy drinks emerging as hidden driver of liver damage in India’s youth, warn experts
Healthcare | April 20, 2026

Energy drinks emerging as hidden driver of liver damage in India’s youth, warn experts

Medical experts point to a growing body of research linking energy drinks to liver injury


Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection
Drug Approval | April 17, 2026

Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions


Briefs: Indoco Remedies and Panacea Biotec
News | April 14, 2026

Briefs: Indoco Remedies and Panacea Biotec

Panacea Biotec receives LoA from CMSS


APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed


Sai Life Sciences posts stellar Q3, revenue surges 27% YoY; PAT nearly doubles
News | February 09, 2026

Sai Life Sciences posts stellar Q3, revenue surges 27% YoY; PAT nearly doubles

Capital expenditure stood at Rs. 405 crore to date against a planned Rs. 700 crore for FY26


Aarti Drugs reports strong Q3 FY26 performance, PAT surges 58% YoY
News | February 06, 2026

Aarti Drugs reports strong Q3 FY26 performance, PAT surges 58% YoY

On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway