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Results For "observations"

251 News Found

Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
Drug Approval | April 28, 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit


Dr. Reddy’s launches integrated care plan to manage irritable bowel syndrome
Digitisation | April 19, 2024

Dr. Reddy’s launches integrated care plan to manage irritable bowel syndrome

Around 7% of the Indian population suffers from IBS


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


Syngene biologics facility to be operational for US, European customers from mid-year
News | March 17, 2024

Syngene biologics facility to be operational for US, European customers from mid-year

New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day


Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility
Drug Approval | March 09, 2024

Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility

The inspection was concluded with few procedural observations