IPCA Labs has its second import alert lifted within two weeks from the USFDA

Active Pharmaceutical Ingredients (API) manufacturer IPCA Laboratories Ltd. announced that its formulations manufacturing facility at SEZ Indore, Pithampur, Madhya Pradesh has received a Voluntary Action Indicated (VAI) classification from the USFDA.

The US drug regulator had conducted an inspection at the facility between June 15 and June 23, 2023.

IPCA Labs in an exchange filing stated that the unit has received the Establishment Inspection Report (EIR), classifying it as "Voluntary Action Indicated" (VAI).

According to USFDA, a VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, the agency will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.

The plant has been asked to address the conditions mentioned in the Form FDA 483 failing which similar conditions could lead to a future inspection being classified as “official action indicated”.

Mumbai-based IPCA Labs produces theobromine, acetylthiophene, and p-bromotoluene as active pharmaceutical ingredients. It sells these APIs and their intermediates globally.

The pharma major, on October 21, also announced that its Ratlam-based plant in Madhya Pradesh received a similar VAI classification from the USFDA following the inspection from June 5-13, 2023.

The company last week announced that its board would meet on November 10 to consider and approve its financial results for the September quarter.

Shares of IPCA Labs are off the day's high but trading 0.8% higher at ₹987.8.