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Results For "Swissmedic"

10 News Found

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility
News | January 10, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed


Carbogen Amcis completes Swissmedic inspection of its facility in Vionnaz, Switzerland
News | September 28, 2022

Carbogen Amcis completes Swissmedic inspection of its facility in Vionnaz, Switzerland

This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


Swissmedic  approves BeiGene's Brukinsa
Drug Approval | February 17, 2022

Swissmedic approves BeiGene's Brukinsa

With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain


Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business
News | February 22, 2025

Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business

The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market


Dishman Carbogen Amcis updates on inspection by EDQM and AIFA
Drug Approval | September 22, 2023

Dishman Carbogen Amcis updates on inspection by EDQM and AIFA

The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine
Biotech | April 13, 2022

Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Switzerland


WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms