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Results For "EU-GMP-certification"

9 News Found

Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance


Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab
News | April 29, 2023

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Biocon Biologics receives EU GMP Certification for its in Bengaluru
News | July 06, 2022

Biocon Biologics receives EU GMP Certification for its in Bengaluru

This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech
News | September 12, 2024

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility


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


Prestige BioPharma’s facility receives EU-GMP certification
Biotech | February 22, 2022

Prestige BioPharma’s facility receives EU-GMP certification

The facility will manufacture its Herceptin biosimilar, Tuznue