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24

Nov

FDA floats a new approach to nitrosamine mitigation

FDA suggests alternative approaches for nitrosamine risk assessments.

The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.
 
These approaches were outlined in recent update on possible mitigation strategies to reduce the risk of nitrosamine impurities in drug products. The update was prompted by reports of certain types of nitrosamine impurities that formed in “several drug products.”...[FDA]

18

Gen

AIFA - Gestione telematica istanze e atti emessi dall’Ufficio GMPMED. Avvio della I Fase dal 17 gennaio 2022

L’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (Ufficio GMPMED), allo scopo di ottimizzare...

14

Gen

“CEP of the future”: project update

The consultation phase of the project to design the Certificate of suitability to the monographs of...

13

Gen

Industry seeks delay for reporting manufacturing volume data

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up...

13

Gen

Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.


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