Aurobindo Pharma Ltd. said on Tuesday that an active-pharmaceutical-ingredient manufacturing plant in Telangana run by its subsidiary received two observations from the US Food and Drug Administration.
The FDA inspection was carried out between Dec. 9 and Dec. 17 at the facility run by Apitoria Pharma Pvt. at Pashamylaram village in Patancheru mandal of Sanga Reddy district, according to an exchange filing.
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"The inspection closed with two observations. The observations are procedural in nature and will be responded to within the stipulated time," the statement said.
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Apitoria Pharma manufacturers, sells, exports and imports all types of chemicals, intermediates, drugs and API. The range of the API products include antibiotics, CNS and CVS, complex molecules, antidiabetics and oncology. The API is the biologically active component of a drug product like a tablet, capsule, cream, or injectable that produces the intended effects.
In September, the Telangana facility had received 10 observations from the US health regulator. Last year, Aurobindo Pharma transferred its antibiotic API division to Apitoria on a slump sale basis for Rs 502.6 crore.
Shares of Aurobindo Pharma closed 2.53% lower at Rs 1,213.45 apiece on the BSE before the announcement, compared to a 1.3% decline in the benchmark Sensex. The share price has risen 19% in the last 12 months.
Twenty out of the 29 analysts tracking the company have a 'buy' rating on the stock, five recommend 'hold' and four suggest 'sell,' according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 26%.
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