Page 14 - Aurobindo Pharma

Aurobindo's oral solid formulations unit under USFDA scrutiny

The company in a filing on Thursday said the OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture

Aurobindo Pharma plunges 8% as USFDA classifies oral solids plant as OAI

USFDA, that had conducted a Current Good Manufacturing Practice (cGMP) inspection at the company's Unit 7 an oral solids formulation manufacturing facility from Sept 19-27, 2019, issued 7 observations

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Pharma shares in focus; Dr Reddy's, Divi's, Granules hit 52-week highs

Lupin, Sun Pharmaceutical, Cadila Healthcare, Aarti Drugs and Aurobindo Pharma were up in the range of 2 per cent to 3 per cent.

Aurobindo Pharma recalls Mirtazapine tablets in US over label error

The product is being recalled due to a label error on declared strength

AuroMedics Pharma recalls over 59000 vials of antipsychotic injection in US

The product was distributed to major wholesalers/distributors who may have further distributed the product throughout the US, it added

Aurobindo recalls heartburn drug ranitidine, two others from US market

Development follows regulatory compliance issues being faced by several of its plants back home; Ranitidine taken off due to the presence of carcinogenic compound

Aurobindo Pharma arm to buy certain biz assets of Profectus BioSciences

Aurobindo Pharma on Thursday said its subsidiary Auro Vaccines LLC has entered into a pact to acquire certain business assets from Profectus BioSciences Inc USA for an upfront cash consideration of USD 11.29 million (around Rs 80 crore) with potential earn-outs on achieving certain milestones. Auro Vaccines LLC is a wholly-owned subsidiary of Aurobindo Pharma USA Inc, USA, which is a wholly-owned arm of the company, Aurobindo Pharma said in a filing to the BSE. The indicative time period for completion of acquisition of research and development assets of Profectus BioSciences Inc is first half of 2020, it added. The acqusition provides access to proprietary and innovative technology platforms for prophylactic use and therapeutic use along with global R&D center, Aurobindo Pharma said. The acquisition will lead to enhancement of research and development capabilities and expertise in developing newer vaccines from basic discovery research into FDA-approved product, it added. Shares

Aurobindo Pharma aims to become debt-free in the next three years

The company's net debt decreased by $71 million quarter-on-quarter to $522 million at the end of September 2019 against $593 million at the end of June 2019

USFDA observes major protocol lapses in Aurobindo's sterile drug unit

Regulator issues Form 483 with as many as 14 observations that could impact ongoing operations at the plant

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