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Results For "US-FDA"

262 News Found

Caplin Group commences operations of Rs. 150 crore oncology facility
News | March 28, 2024

Caplin Group commences operations of Rs. 150 crore oncology facility

The facility will manufacture tablets, capsules, and injections for the oncology segment


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


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


USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy
Biotech | March 12, 2024

USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy

It is the first autotaxin inhibitor to be investigated in cancer patients


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


USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility
Drug Approval | March 09, 2024

USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility

The company will provide comprehensive response to USFDA for the observations


Briefs: Eugia Pharma Specialities and Eugia SEZ
News | March 01, 2024

Briefs: Eugia Pharma Specialities and Eugia SEZ

Eugia Pharma Specialities restarts production at terminally sterilized product lines


Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility
Drug Approval | February 26, 2024

Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity


Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India
News | February 24, 2024

Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India

Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully


Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides
News | February 20, 2024

Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides

IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China