Last Updated : Monday, January 13, 2020 16:49:26

Tag Archives: OAI

US Regulators slam 3 observations to LUPIN’s Tarapur facility

MUMBAI | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceuticals sector Indian Major Lupin Ltd said of its Tarapur facility being inspected by US regulators and the inspection has been closed with 3 observation, further the facility being classified under the OAI (Official Action Indicated) category. The filing

USFDA issues warning, initiates official action against LUPIN’s Mandideep unit

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indian Pharma major Lupin Ltd said of US FDA (Food & Drugs Administration) having issued warning letter and initiated official action against Mandideep facility of the company. The company update as submitted to the Indian Bourses read

USFDA slams Form 483 to Torrent Pharma’s Dahej facility, official action initiated

DAHEJ | AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses late on Wednesday night, Ahmedabad headquartered pharma major Torrent Pharmaceuticals Ltd said of the company having classified as Official Action Initiated by US food & drugs regulator. The Dahej facility of the company was inspected in March 2019

USFDA inspection at Alkem’s St. Louis (US) facility concluded with observations, regulators indicate official action

ST. LOUIS (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered Indian Pharam company Alkem Laboratories Ltd said of the USFDA (US Food & Drugs Administration) concluded inspection at St. Louis (US) facility of the company and that the company will close out all observations

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