Alembic Pharmaceuticals has informed the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility located at Panelav from 4th October, 2022 to 14th October, 2022. The USFDA issued a Form 483 with 4 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
The above information is a part of company’s filings submitted to BSE.
