Page 15 - Aurobindo Pharma

Exposure to US market causing constant FDA scrutiny for big drug firms

Dr Reddy's was in the news for falling short of expectations during routine audits conducted by the US drug regulator

Aurobindo Pharma gets 14 observations from the USFDA for Hyderabad plant

The observations issued by the USFDA notifies the company's management of objectionable conditions at the inspected facility

Regulatory overhang may dent Aurobindo Pharma earnings estimate by 15-20%

The stock tanked to its five-year low before closing 8.7 per cent lower on Thursday

Aurobindo Hyderabad plant in regulatory trouble, share price falls 8%

The US Food and Drug Administration issued Form 483 with 14 observations to the company following the completion of inspection from November 4-14.

Aurobindo Pharma hits 5-year low on USFDA observations for Hyderabad plant

The stock tumbled 9 per cent to Rs 393, its lowest level since September 2014.

Aurobindo consolidated Q2 profit before tax up 5.9% at Rs 904 crore

Gross profit margin slipped to 20.8% during the quarter under review from 21.6% in the year-ago previous quarter owing to higher expenditure, which grew by 19%

Aurobindo Pharma USA recalls stomach ulcer drug Ranitidine over impurities

This is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported carcinogenic impurity in the drug at low levels

Aurobindo Pharma receives 8 US FDA observations for two of its facilities

Observations are related to procedural improvements, not data integrity, says the company

Aurobindo Pharma trades near 52-wk low as Hyd units come under US FDA lens

The management believes that these observations are related to procedural improvements and none of the observations are related to data integrity.

Aurobindo Pharma rises 3% after firm's clarification on FDA observations

The exchange had sought a clarification from the company regarding declining share prices on the back of USFDA observations

Pharma Monday blues: USFDA warnings drag down Glenmark, Aurobindo stocks

The Nifty Pharma index fell 3.35 per cent during the day.

FDA observations on Telangana plant a fresh headache for Aurobindo Pharma

The Telangana unit in question is an important one contributing about a fifth to US revenues

Sebi imposes Rs 22.7 crore fine on Aurobindo Pharma for insider trading

The order said that the penalty amount will be paid within 45 days of receipt of this order

Sebi imposes Rs 22 cr fine on Aurobindo Pharma, promoters, related entities

The company failed to disclose the price sensitive information regarding the Licensing and Supply Agreements to the stock exchange.

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Aurobindo Pharma gains nearly 8% on growth prospects in US market

The completion of Sandoz acquisition and new product launches are triggers

Aurobindo Q1 profit up 39.5% at Rs 636 crore on strong revenue growth

Revenue from operations rose 28.1% year-on-year to Rs 5,444.6 crore during the quarter under review

Aurobindo Pharma confident of all-round growth in the US market

Aurobindo had reported Rs 19,563.6 crore in revenues in FY19 with an year-on-year growth of 18.5 per cent

Carcinogens in drug: US FDA seeks full re-evaluation in all Aurobindo units

Firm may have a tough task ahead improving manufacturing practices across the board through remediation running into months and years

Aurobindo Pharma gets warning letter from USFDA for Andhra facility

Aurobindo Pharma share price fell as much as 7.7 per cent to Rs 578.75