Last Updated : Wednesday, May 15, 2019 18:11:04

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 associated with inspection.

The filing read, US FDA Inspection at Alkem’ s manufacturing facility located at St. Louis, USA dated 6th February, 2019 and 22nd March, 2019, this is to inform that the Company has received a letter from the US FDA classifying the inspection conducted at its St. Louis facility as Official Action Indicated (OAI).

St. Louis facility contributes about 2% of the Company’s total US revenues or about 0.5% of the Company’s consolidated revenues.

The Company believes that this classification will not have any significant impact on existing supplies or the existing revenues from the operations of this facility.

The Company shall continue to work closely with US FDA to close out all the observations associated with this inspection.

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