USFDA inspection at Alembic Pharmaceuticals' Injectable Facility (F-3) at Karakhadi

The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' Injectable and Ophthalmic Facility (F-3) located at Karkhadi from 16th March, 2023 to 24th March, 2023. The USFDA issued a Form 483 with 2 minor 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 484.45 as compared to the previous close of Rs. 488.95. The total number of shares traded during the day was 3115 in over 376 trades.

The stock hit an intraday high of Rs. 492.75 and intraday low of 483.05. The net turnover during the day was Rs. 1522687.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA Inspection Injectable OphthalmicFacility Karkhadi Form483 2MinorObservations