Page 8 - Aurobindo Pharma

USFDA nod to Unit IV a breather for Aurobindo Pharma; share price up 20.4%

Analysts remain positive on Aurobindo's future prospects including the US despite the higher base

Aurobindo Pharma soars 19% as Unit IV receives EIR with VAI status from FDA

The Company has received the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAl) status from the US Food & Drug Administration (USFDA) for Unit IV.

Aurobindo Pharma gains 5% post December quarter results

The stock of the drug company was trading higher for the fifth straight day, up 14 per cent, against a 4 per cent rise in the S&P BSE Sensex during the period.

Aurobindo Pharma Q3 net marginally down at Rs 705 cr, revenue up 12%

According to a filing with the bourses, revenues from operations during the quarter under review was up by nearly 12 per cent to Rs 5,895 crore. It was Rs 5,269.7 crore in Q3 FY19.

Aurobindo Pharma Q3 PBT rises 6% to Rs 942.8 cr; revenues up 11.9%

The formulations revenues for the quarter posted a growth of 17.4 per cent year-on-year at Rs 5,104 cr

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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Currently, Ramo Cements' stock is hovering in a range, after a sharp up move, offering fresh buying opportunity to those who missed the chance earlier

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.