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FDA readies GDUFA III as US strives to achieve its distant dream of self-sufficiency in drugs

Over the last few years, both India and the United States have voiced concerns about their high dependence on China for active pharmaceutical ingredients (APIs) and drug intermediates. A shortfall of APIs and drugs during the coronavirus pandemic exposed America’s heavy reliance on India and China for a wide range of life-saving drugs.

The situation, which is a national security and public health risk, has been further exacerbated by the ongoing serious energy crunch in China, the world’s largest API exporter. The US accounted for 12.5 percent of China’s total API export value in 2019. China is also the largest supplier of intermediates to India, which in turn is a crucial supplier of APIs for life saving drugs to the US.

Our latest compilation of facilities registered with the US Food and Drug Administration (FDA) to supply generic drugs into the United States in the coming year reveals that things haven’t changed much – the number of API manufacturing facilities in India (183) and China (102) are almost three and a half times more than those in the US (86)....[PharmaCompass]



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...



“CEP of the future”: project update

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



Industry seeks delay for reporting manufacturing volume data

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



Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.