Aurobindo Pharma’s API unit in Telangana gets VAI status from USFDA

Aurobindo Pharma on Tuesday, January 28, said the United States Food and Drug Administration (USFDA) has issued an establishment inspection report (EIR) to its subsidiary’s active pharmaceutical ingredient (API) facility in Telangana, classifying it as voluntary action indicated (VAI).

The Unit 2, API manufacturing facility is of Apitoria Pharma Pvt Ltd, a wholly-owned subsidiary of the company. It is located at Gaddapotharam village IDA, in Sanga Reddy district in Telangana.

The USFDA inspected the facility from September 23 to September 27, 2024.

Last month, Unit V, another API manufacturing facility of Apitoria Pharma, received two observations from the USFDA, described as procedural in nature. Aurobindo Pharma said it would respond to the observations in the stipulated time frame. The US drugs regulator inspected the facility from December 9 to December 17, 2024.

Last week, brokerage firm Investec initiated a FAST (a high conviction short-term analyst idea) on drug manufacturer Aurobindo Pharma Ltd. with a price target of ₹1,930.

The brokerage said that the second half of the current financial year will be better than the first, and that will contribute to the re-rating of the stock.

Aurobindo also has the highest contribution from the exports market among Indian pharma companies, and a depreciating rupee will benefit the company, Investec said in its note.

Aurobindo Pharma shares were trading 1.17% lower at ₹1,162.45 apiece at 10.10 am on Tuesday, January 28. The stock has fallen 17.21% in the last six months.

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