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Apr 19, 2017 03:31 PM IST | Source: Moneycontrol.com

Aurobindo Pharma gets 6 observations from USFDA for its Unit-3 plant in Hyderabad

Aurobindo Pharma on Wednesday said it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA) for its Unit-III formulation facility located at Bachupally in Hyderabad.

Aurobindo Pharma gets 6 observations from USFDA for its Unit-3 plant in Hyderabad

Viswanath Pilla

Moneycontrol News

Aurobindo Pharma on Wednesday said it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA) for its Unit-III formulation facility located at Bachupally in Hyderabad.

The plant was inspected from April 10-18 by US FDA.

All the observations are related to procedural improvements, the company said. "None of the observations are related to data integrity," Aurobindo said in a statement to stock exchanges.

"The company will be responding as per the prescribed time lines," it added.

The plant - Unit-III - makes oral formulations with 125 abbreviated new drug applications (ANDA) filings in US as on 31 March 2016. Of these, 99 have received final approvals, 16 are tentative approvals and 10 are under review.

Aurobindo has 22 active pharmaceutical ingredient and formulation manufacturing facilities with three in the US and one in Brazil.

Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan in 15 days and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.​

CNBC-TV18 earlier reported that Aurobindo got 5-6 observations of procedural in nature.

Share of Aurobindo dropped 3.25 percent and were trading at Rs.642 on BSE at 2.58 pm, the benchmark Sensex declined 0.04 percent to 29,306.99 points.
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