Indian pharmas account for over half of US FDA 'warning letters' this year




While Ahmedabad-based Zydus Cadila became the latest to receive a warning letter from the US Food and Drug Administration (FDA) for quality violations at its manufacturing plant in Moraiya, the US drug regulator's data reveals almost half the warning letters for manufacturing violations issued so far this year were for Indian drug makers.


The data reviewed by Business Today revealed almost 15 Indian companies - including Lupin, Aurobindo, Jubilant Generics, Emcure and Strides Pharma Sciences-received notices out of 32 warning letters issued till November this year by the Office of Manufacturing Quality, US FDA.


The other companies that received US FDA's warning letter this year include Aurobindo Pharma's Srikakulam plant, CTX Lifesciences Surat plant, Lantech Pharma's Hyderabad unit, Rxhomeo's Hyderabad unit, Glint Cosmetics' Navi Mumbai plant, Centurion Laboratories' Manjusar plant in Gujarat, B. Jain Pharmaceuticals's unit at Bhiwadi in Rajasthan, Jubilant Generics's unit in Uttaranchal, Hospira Healthcare's Irungattukottai plant near Chennai, Vipor Chemicals at Baroda and Anicare Pharmaceuticals Navi Mumbai.


Most violations relate to rectifiable documentation, data maintenance, batch-wise consistent production quality, data on supply chain, stability issues, microbial contamination and quality checks, said an expert in the field.


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