USFDA again puts a spotlight on Aurobindo Pharma and Cipla. (PTI) Aurobindo Pharma has clarified that the USFDA observations made were non-serious in nature, while Cipla is working closely with the agency to comprehensively address all the observations. Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients. Aurobindo Pharma's US facility receives nine observations from US FDA: Our Bureau, Mumbai Friday, June 5, 2020, 13:10 Hrs [IST] Aurobindo Pharma announced that its wholly-owned subsidiary AuroLife Pharma LLC's oral solid manufacturing facility located at Dayton, New Jersey has received nine observations from United States Food and Drug Administration (FDA). Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 228 million for the 12 months ending October 2020. After CNBC-TV18 reported that the plant had received a warning letter, Aurobindo Pharma’s stock fell as much as 20.6% on Monday, its steepest in over eight years. 09 December 2020 Last Updated at 10:31 am | Source: PTI ; Aurobindo Pharma gets USFDA nod for sedative drug. Shares of Aurobindo Pharma hit an over five-year low of Rs 393, down 9 per cent on the BSE on Thursday after the company received a Form 483 from US Food and Drug Administration (USFDA) with 14 observations for its Hyderabad facility. Aurobindo Pharma on Thursday said it had entered into an agreement to develop, commercialise and manufacture U.S. firm COVAXX’s COVID … Formulations revenues across geographies grew at a healthy pace. ETCFO; February 26, 2020, 13:07 IST 09 Dec, 2020, 11.00 AM IST Hyderabad: Pharma major, Aurobindo Pharma Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 µg/50 mL and 400 µg/100 mL Single Dose flexible containers (Bags).. Aurobindo's Dexmedetomidine HCl in 0.9% Sodium Chloride … We believe that these observations are related to procedural improvements and none of the observations is related to data integrity," it added. Aurobindo Pharma rose 1.13percent to Rs 905.95 after the company said it received US drug regulaotr's approval for dexmedetomidine HCL in 0.9percent sodium chloride injection. On the NSE, it fell 6.53% to Rs 753.50. While Aurobindo Pharma got some relief, Cipla received a warning letter. Aurobindo Pharma, Zydus, other drug firms recall various products in US market As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices Shares of Aurobindo Pharma on Wednesday rose 20.40 per cent to close at Rs 602.25 per scrip on the BSE. Sales grew by 15.8% y-o-y to Rs. An FDA inspection of an Aurobindo Pharma manufacturing facility last fall noted more than half a dozen concerns, but at the time the drugmaker indicated they should all be quickly fixable. "The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest," it added. Aurobindo Pharma believes that the Aurobindo Pharma Foundation – Best CSR Award, 2020 – Communication It is a most delighted and exciting moment to share that Aurobindo Pharma Foundation, which is the philanthropic arm of Aurobindo Pharma Limited, has been honored as a best CSR (Corporate Social Responsibility) institution under Telangana CSR Leadership awards-2020 in the space of health and nutrition by Asia HRD … On June 4, 2020, with respect to the mentioned inspection, the company had received a letter from USFDA classifying the inspection as "Official Action Indicated". The stock declined 6.37% to Rs 754 per share on the BSE. This follows the earlier letter dated June 4, 2020, issuing an OAI (Official Action Indicated) status for this facility. At the end of the inspection, a 'Form 483' was issued with 9 observations. Aurobindo Pharma received establishment inspection report (EIR) with voluntary action initiated status from the US Food and Drug Administration (FDA) for unit VIII of its active pharmaceutical ingredient (API) manufacturing facility at… Mumbai: Shares of India’s second largest drug maker Aurobindo Pharma fell to their lowest in five years after it received 14 observations from the US Food and Drug Administration for its manufacturing facility at Pashamylaram near Hyderabad. Aurobindo Pharma said it believes the existing business from this facility will not be impacted. 6,483 crore backed by a sturdy 18% growth in the formulations segment while API sales grew at a slower pace of 2.9% y-o-y. Aurobindo Pharma and Cipla have received status from USFDA on previous inspections. Aurobindo Pharma gets USFDA nod for sedative drug. New Delhi, Dec 9 (PTI) Drug major Aurobindo Pharma On Wednesday said it … “The Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV, from November 4, 2019, to November 13, 2019, is still open and under review, by way of rescindment of 90-day VAl letter that was issued by them on February 18, 2020,” Aurobindo Pharma said in a regulatory filing on Friday. Aurobindo Pharma Limited (Aurobindo) reported strong results for Q2FY21 which met the street’s high expectations. Hyderabad headquartered pharmaceutical company Aurobindo Pharma is under the US Food and Drug Administration scrutiny once again.While the US regulator is conducting inspections at Aurobindo pharma’s Unit – IV at Pashamylaram in Medak district of Telangana, the inspections at its units V and VIII happened last week, people aware of the matter said. Aurobindo now has a total of 459 abbreviated new drug application (ANDA) approvals (431 final and 28 tentative) from USFDA. After Market: PCJ shines, Titan tanks, Aurobindo swallows a bitter pill; 37 stocks 'overbought' Pharma weekly wrap: Pharma stocks bounce back on buying interest; USFDA again puts a spotlight on Aurobindo Pharma and Cipla have 293 words, post on cfo.economictimes.indiatimes.com at February 26, 2020. Aurobindo Pharma shares tanked almost 7% intraday on Thursday on the back of the U.S. Food and Drug Administration (USFDA) issuing a warning letter … The stock of drug company was trading at its lowest level since September 2014. Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 µg/50 mL and 400 µg/100 mL Single Dose flexible containers (bags). FDA issues Form 483 with 9 observations to Aurobindo Pharma''s ... 2020 to February 12, 2020. Read Also: Aurobindo Pharma wins USFDA nod for a generic version of Mucinex Tablets "At the end of the inspections, we have been issued a Form 483 with four observations for each facility. Aurobindo Pharma, however, did not provide any details about the observations made by USFDA Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad Shares of Aurobindo Pharma Ltd. fell over 6% after the company’s step-down subsidiary received a warning letter from the U.S. health regulator for its unit in New Jersey. 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