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.

Related Posts

Mankind Pharma to Acquire 70% Stake in Belgium’s ACTx

Shares of Mankind Pharma fell more than 2% on 16 October after the company announced that it has signed an agreement to acquire a 70% stake in Belgium-based biotechnology company…

Can a drug licence be suspended before a hearing? Karnataka HC explains rule

NEW DELHI: Can a drug licensing authority suspend a pharmaceutical distributor’s licence while issuing a show-cause notice, before considering its response? The Karnataka high court has said the procedure under…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Mankind Pharma to Acquire 70% Stake in Belgium’s ACTx

Mankind Pharma to Acquire 70% Stake in Belgium’s ACTx

Can a drug licence be suspended before a hearing? Karnataka HC explains rule

Can a drug licence be suspended before a hearing? Karnataka HC explains rule

A Boy survives 18th Floor Fall, thanks to Yashoda Medicity

A Boy survives 18th Floor Fall, thanks to Yashoda Medicity

AstraZeneca, NIPER Raebareli partner to upgrade 25 clinical trail sites

AstraZeneca, NIPER Raebareli partner to upgrade 25 clinical trail sites

FDA clears ImmunityBio’s Anktiva expansion in bladder cancer after regulatory whiplash

FDA clears ImmunityBio’s Anktiva expansion in bladder cancer after regulatory whiplash

Sun Pharma Approves Rs 10,000 Crore Fundraising Through NCDs

Sun Pharma Approves Rs 10,000 Crore Fundraising Through NCDs