Aurobindo Pharma allegedly concealed facts about cancer-causing agent NDMA in type-2 diabetes drug metformin
Aurobindo was scheduled to acquire the portfolio with an upfront purchase price of $900 million in cash
The stock is trading higher for the fourth straight day and has rallied 38 per cent during the period.
Currently, Unit 4 has 15 abbreviated new drug applications (ANDA) approvals pending over the next one year.
On February 18, the US FDA issued the EIR with voluntary action indicated for Aurobindo Pharma's Unit IV injectable formulations unit
Analysts remain positive on Aurobindo's future prospects including the US despite the higher base
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.
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.
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.
The formulations revenues for the quarter posted a growth of 17.4 per cent year-on-year at Rs 5,104 cr
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
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
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
Lupin, Sun Pharmaceutical, Cadila Healthcare, Aarti Drugs and Aurobindo Pharma were up in the range of 2 per cent to 3 per cent.
The product is being recalled due to a label error on declared strength
The product was distributed to major wholesalers/distributors who may have further distributed the product throughout the US, it added
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 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
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
Regulator issues Form 483 with as many as 14 observations that could impact ongoing operations at the plant