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Results For "GMP"

507 News Found

Venus Remedies eceives GMP certification from Libya
News | January 18, 2024

Venus Remedies eceives GMP certification from Libya

The certification underscores Venus Remedies Limited's adherence to stringent quality control measures


Supriya Lifesciences received GMP certification from ANVISA Brazil
News | January 06, 2024

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA


Evonik launches GMP-quality plant-based squalene
News | November 08, 2023

Evonik launches GMP-quality plant-based squalene

PhytoSquene now available for clinical and commercial use


Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection
Drug Approval | October 18, 2023

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years


Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection
Drug Approval | September 02, 2023

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection

The inspection has concluded successfully on 1st September 2023 without any critical/major observation


NIH and Exothera partner to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US
News | August 24, 2023

NIH and Exothera partner to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US

NIH’s candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials
Clinical Trials | June 29, 2023

Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials

Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials


Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany
Drug Approval | June 10, 2023

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site