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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 the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to meet the February deadline set by the US Food and Drug Administration (FDA)...

The agency wants reports for calendar year 2020 to be submitted by 15 February 2022 and reports for calendar year 2021 to be reported by 16 May 2022....[RAPS]

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

Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.


11

Gen

Merger of Kalexsyn Inc. into Dipharma Inc.

Dipharma Francis (“Dipharma”), a global CDMO and a leading manufacturer of APIs and intermediates...

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