Cipla's Patalganga plant gets Voluntary Action Indicated (VAI) from USFDA

25 Jun 2024 , 01:51 PM

Cipla Ltd., a Mumbai-based medicine producer, has informed the exchanges that its Patalganga manufacturing plant has earned Voluntary Action Indicated status from the US Food and medicine Administration (USFDA).

The Patalganga facility received a form 483 with six observations from the regulator in April of this year.

A Voluntary Action Indicated (VAI) status indicates that undesirable circumstances or procedures were discovered at the facility, but the agency (USFDA) does not intend to take or propose any administrative or regulatory action. It is lower than Official Action Indicated (OAI), implying that regulatory and/or administrative steps are recommended.

From March 28 to April 4, 2024, the US drug regulator conducted a normal current Good Manufacturing Practices (cGMP) inspection at the site.

Cipla’s Patalganga factory develops both Active Pharmaceutical Ingredients (APIs), the primary raw components for medications, and formulations.

The USFDA recently inspected Cipla’s Goa factory and issued six observations. The aforementioned unit has been issued a warning notice since February 2020. The Goa facility was inspected between June 10 and 21, 2024.

Cipla’s Indore factory has been under a warning notice since November 2023.

Cipla also inked a non-exclusive patent license arrangement with Takeda last week for the medicine Vonoprazan in the Indian market. The medicine is intended to treat people suffering from acid-related disorders.

At around 1.25 PM, Cipla was trading 0.44% lower at ₹1,497.85 per piece, against the previous close of ₹1,504.40 on NSE. The counter touched an intraday high and low of ₹1,517, and ₹1,496, respectively.

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