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Results For "regulatory"

1533 News Found

GPCB issues directive for closure of Tatva Chintan Pharma Chem Ankleshwar plant
Policy | September 14, 2024

GPCB issues directive for closure of Tatva Chintan Pharma Chem Ankleshwar plant

GPCB has also asked to submit a bank guarantee of Rs. 2, 00,000 for compliance assurance at the time of revocation and has also ordered to deposit interim environment damage compensation amount


Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington
Drug Approval | September 11, 2024

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington

Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding


Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Clinical Trials | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration


Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9
Clinical Trials | September 11, 2024

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9


Atal Innovation Mission, NITI Aayog hosts 20th MedTech Mitra Technical advisory meeting
Policy | September 10, 2024

Atal Innovation Mission, NITI Aayog hosts 20th MedTech Mitra Technical advisory meeting

MedTech Mitra initiative aims to empower MedTech innovators and advance healthcare solutions


Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes


Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head
People | September 05, 2024

Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head

Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry


Exyte acquires TTP Group to accelerate growth of biopharma and life sciences business
News | September 05, 2024

Exyte acquires TTP Group to accelerate growth of biopharma and life sciences business

TTP Group is a leading engineering firm specializing in biotech and pharmaceutical industry


Tolebrutinib meets primary endpoint in HERCULES phase 3 study
Clinical Trials | September 03, 2024

Tolebrutinib meets primary endpoint in HERCULES phase 3 study

Phase 3 study results will form the basis for future discussions with global regulatory authorities