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Results For "SPE"

4950 News Found

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval | May 06, 2025

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice


Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence


OneSource Specialty Pharma reports consolidated Q4 FY25 PAT at Rs. 98.50 Cr
News | May 06, 2025

OneSource Specialty Pharma reports consolidated Q4 FY25 PAT at Rs. 98.50 Cr

The company has posted net loss of Rs. 17.97 crores for the Financial Year ended March 31, 2025


USFDA inspection at Concord Biotech’s API facility at Dholka
Drug Approval | May 03, 2025

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management


USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility
Drug Approval | May 01, 2025

USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility

The Subsidiary has received one inspectional observation in Form 483


Medanta to set up a 400-bed super specialty hospital in Guwahati
Healthcare | April 30, 2025

Medanta to set up a 400-bed super specialty hospital in Guwahati

The Board has also approved plans to invest approximately Rs. 500 crores including cost of land in developing a state-of-the-art, 400-bed super specialty hospital


Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat
Drug Approval | April 29, 2025

Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat

The inspection concluded with 6 observations and none of them were related to Data Integrity


FUJIFILM India to sell Spectra Logic’s tape storage products, software in India
News | April 25, 2025

FUJIFILM India to sell Spectra Logic’s tape storage products, software in India

Distribution agreement enables FUJIFILM India to offer Spectra Logic advanced tape libraries and software solutions to enterprise customers and channel partners


Lonza joins CMAC to enhance service offering for specialty, enhanced drug product and particle technologies
News | April 15, 2025

Lonza joins CMAC to enhance service offering for specialty, enhanced drug product and particle technologies

Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC) aims to accelerate the digital transformation of CMC development and manufacturing approaches