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8506 News Found

USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations


Lupin signs distribution agreement with Celnova for orphan drug NaMuscla
Supply Chain | September 28, 2024

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia


Baxter launches nextgen airway clearance system
News | September 28, 2024

Baxter launches nextgen airway clearance system

Developed in consultation with clinicians and patients for an enhanced user experience


USV launches Q rite tablets for treatment of rare aprhythmia in heart patients
News | September 27, 2024

USV launches Q rite tablets for treatment of rare aprhythmia in heart patients

Quinidine Sulphate helps manage rare irregular heartbeat conditions


Takara Bio Europe unveils new large-scale NGS profiling system and chemistries
News | September 27, 2024

Takara Bio Europe unveils new large-scale NGS profiling system and chemistries

The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run


Torrent Pharmaceuticals refutes claims of Shelcal 500 allegedly failing CDSCO quality test
News | September 27, 2024

Torrent Pharmaceuticals refutes claims of Shelcal 500 allegedly failing CDSCO quality test

The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious


Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality
News | September 27, 2024

Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality

The samples of both products mentioned in the CDSCO list are spurious and not manufactured by Alkem


Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan
Drug Approval | September 26, 2024

Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg