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Results For "USFDA"

1355 News Found

Jagsonpal Pharmaceuticals launches QueeZy-ER
News | March 09, 2024

Jagsonpal Pharmaceuticals launches QueeZy-ER

The product combines proven efficacy of Doxylamine succinate 20 mg and Pyridoxine hydrochloride 20 mg in an Extended Release formulation


Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA
News | March 07, 2024

Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA

ANVISA issues CGMP to Concord Biotech’s Unit I


Dr. Mandaviya inaugurates Sadhana Nitro Chem’s Para Amino Phenol bulk drug plant
Policy | March 06, 2024

Dr. Mandaviya inaugurates Sadhana Nitro Chem’s Para Amino Phenol bulk drug plant

Sadhana Nitro Chem's plant is the second plant in the world to manufacture pAP from Nitrobenzene


Cipla incorporates JV company in USA
News | March 02, 2024

Cipla incorporates JV company in USA

Cipla completes transfer of Generics Business Undertaking


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


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


Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA
Drug Approval | February 14, 2024

Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA

The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.


Glenmark partners Pfizer to launch Abrocitinib in India
Drug Approval | February 01, 2024

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis