News | April 14, 2025
Nureca’s manufacturing subsidiary secures USFDA registration
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards
The European regulator will conduct a re-inspection of the facility to verify the compliance
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Expand the scope of the Production-Linked Incentive (PLI) scheme and increase its allocation to cover more pharmaceutical products and raw materials
Morepen Laboratories approves hiving off of medical devices business
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
Investment will fund expansion to meet rising demand for CRDMO services
Acquisition expands high-value medical platform
The biosimilar Ustekinumab has been developed and manufactured by the company
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