Cipla’s Patalganga facility receives VAI status from USFDA

Mumbai-based drug manufacturer Cipla Ltd. announced that its Patalganga manufacturing facility has been granted a Voluntary Action Indicated (VAI) status by the United States Food and Drug Administration (USFDA).

This status follows a routine inspection by the USFDA from March 28 to April 4, 2024, which resulted in a form 483 with six observations. A VAI status indicates that, while there were objectionable conditions or practices found, the USFDA does not plan to take or recommend any regulatory action. This is less severe than an Official Action Indicated (OAI) status, which would suggest regulatory or administrative actions.


The Patalganga facility produces both Active Pharmaceutical Ingredients (APIs) and formulations.

Cipla has faced other regulatory challenges recently. The Goa facility received six observations from the USFDA following an inspection from June 10 to June 21, 2024, and has been under a warning letter since February 2020. Additionally, Cipla’s Indore facility has been under a warning letter since November 2023.

In other news, Cipla signed a non-exclusive patent license agreement with Takeda for Vonoprazan, a drug used to treat acid-related illnesses in the Indian market.

As of 12:25 PM, Cipla shares were trading at ₹1,501.10.