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Results For "GMP"

507 News Found

Evonik partners with South Korean ST Pharm to increase its offerings for RNA and nucleic acid delivery
News | January 09, 2025

Evonik partners with South Korean ST Pharm to increase its offerings for RNA and nucleic acid delivery

Increases speed to market for drug developers working on nucleic acid therapeutics


ProBioGen expands protein and viral manufacturing to drive continued growth
News | January 09, 2025

ProBioGen expands protein and viral manufacturing to drive continued growth

This strategic move aims to address the increasing global demand for biologics, enhancing ProBioGen's ability to support partners from cell line development t


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection
Drug Approval | December 30, 2024

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection

Cenexi is committed to working closely with the ANSM to address the observations


Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells


Briefs: Alembic Pharmaceuticals and Veerhealth Care
Drug Approval | December 12, 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market


Suven to acquire 56% stake in ADC specialist NJ Bio for US$64.4 million
News | December 09, 2024

Suven to acquire 56% stake in ADC specialist NJ Bio for US$64.4 million

This acquisition positions Suven as a key player in one of the fastest growing segments of the Pharma CDMO landscape


Sartorius Stedim Biotech opens center for bioprocess innovation in USA
Biotech | November 22, 2024

Sartorius Stedim Biotech opens center for bioprocess innovation in USA

New research labs and process development services to enable next generation therapeutics