Alembic Pharmaceuticals gets 5 observations from USFDA for Solid Oral Formulation Facility (F-4) at Jarod

The United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 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. 583.75 as compared to the previous close of Rs. 586.15. The total number of shares traded during the day was 2096 in over 338 trades.

The stock hit an intraday high of Rs. 590.00 and intraday low of 580.00. The net turnover during the day was Rs. 1224006.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA PreApprovalInspection Form483 5Observations