Caplin Point Laboratories Limited

Caplin Point Laboratories Limited has received a final approval by its subsidiary Caplin Steriles Limited from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRONESTYL, from Apothecon Inc.

Hikal Limited 

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru, Karnataka. The inspection, conducted from 3rd February 2025 till 7th February 2025, concluded with six observations. The company will address the observations and submit its response to the USFDA within the stipulated time frame.

Cipla Limited 

Cipla Limited said that the United States Food and Drug Administration (USFDA) has classified the current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Virgonagar, Bengaluru, India above referred inspection as Voluntary Action Indicated (VAI). The inspection was carried between 7 - 13th November, 2024.