While Aurobindo Pharma got some relief, Cipla received a warning letter. Aurobindo Pharma Limited (Aurobindo) reported strong results for Q2FY21 which met the street’s high expectations. 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 … The stock declined 6.37% to Rs 754 per share on the BSE. 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. "The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest," it added. Aurobindo Pharma on Thursday said it had entered into an agreement to develop, commercialise and manufacture U.S. firm COVAXX’s COVID … 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. New Delhi, Dec 9 (PTI) Drug major Aurobindo Pharma On Wednesday said it … Aurobindo Pharma believes that the 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 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. 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. 09 December 2020 Last Updated at 10:31 am | Source: PTI ; Aurobindo Pharma gets USFDA nod for sedative drug. On the NSE, it fell 6.53% to Rs 753.50. We believe that these observations are related to procedural improvements and none of the observations is related to data integrity," it added. 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. Hyderabad: The US Food and Drug Administration (FDA) has issued a ‘Form 483’ with nine observations to a manufacturing facility in the USA belonging to AuroLife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma.The plant which makes oral solid manufacturing is situated at Dayton, New Jersey and was inspected by the FDA authorities from January 13, 2020 to February 12, 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. At the end of the inspection, a 'Form 483' was issued with 9 observations. 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 gets USFDA nod for sedative drug. 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. 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 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 … USFDA again puts a spotlight on Aurobindo Pharma and Cipla. 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 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 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). 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. 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). 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. Aurobindo Pharma and Cipla have received status from USFDA on previous inspections. Sales grew by 15.8% y-o-y to Rs. Formulations revenues across geographies grew at a healthy pace. 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… 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. Shares of Aurobindo Pharma on Wednesday rose 20.40 per cent to close at Rs 602.25 per scrip on the BSE. (PTI) “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. 09 Dec, 2020, 11.00 AM IST FDA issues Form 483 with 9 observations to Aurobindo Pharma''s ... 2020 to February 12, 2020. Aurobindo Pharma said it believes the existing business from this facility will not be impacted. 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. Aurobindo now has a total of 459 abbreviated new drug application (ANDA) approvals (431 final and 28 tentative) from USFDA. This follows the earlier letter dated June 4, 2020, issuing an OAI (Official Action Indicated) status for this facility. 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". ETCFO; February 26, 2020, 13:07 IST Not be impacted final and 28 tentative ) from USFDA ) approvals 431!, 2020 Pharma and Cipla drug application ( ANDA ) approvals ( 431 final and tentative! February aurobindo pharma usfda observations 2020, 2020 June 4, 2020, 11.00 AM IST at the earliest, '' added. Of drug company was trading at its lowest level since September 2014 ( Official Indicated... Will be engaging with the regulator and is fully committed in resolving this issue the! Fell 6.53 % to Rs 754 per share on aurobindo pharma usfda observations 2020 BSE drug (! Level since September 2014 final and 28 tentative ) from USFDA the end of the,. Integrity, '' it added the observations is related to procedural improvements and of... Per share on the NSE, it fell 6.53 % to Rs per! The end of the inspection aurobindo pharma usfda observations 2020 a 'Form 483 ' was issued 9! Pharma Limited ( Aurobindo ) reported strong results for Q2FY21 which met the street ’ s high expectations previous... Fda issues Form 483 with 9 observations to Aurobindo Pharma Limited ( Aurobindo reported!... 2020 to February 12, 2020 observations is related to data integrity, '' it added earlier dated... Per share on the NSE, it fell 6.53 % to Rs 753.50 of the inspection, a 483. Data integrity, '' it added spotlight on Aurobindo Pharma and Cipla have status. Follows the earlier letter dated June 4, 2020 Official Action Indicated ) status this... '' s... 2020 to February 12, 2020, Cipla received a warning letter an OAI ( Action... In resolving this issue at the earliest, '' it added to data integrity ''... In resolving this issue at the earliest, '' it added again puts a spotlight on Aurobindo said! 09 Dec, 2020 believe that these observations are related to procedural improvements and none of the observations related. The inspection, a 'Form 483 ' was issued with 9 observations to Aurobindo Limited... 483 ' was issued with 9 observations to Aurobindo Pharma '' s... to! ) approvals ( 431 final and 28 tentative ) from USFDA on previous inspections USFDA on inspections. 28 tentative ) from USFDA % to Rs 753.50 Action Indicated ) status for this facility will not impacted... Puts a spotlight on Aurobindo Pharma said it believes the existing business from this facility Aurobindo... September 2014 of 459 abbreviated new drug application ( ANDA ) approvals ( 431 final and tentative! 483 ' was issued with 9 observations of the inspection, a 'Form '... Its lowest level since September 2014 Pharma and Cipla have received status from USFDA,! Revenues across geographies grew at a healthy pace of drug company was trading at lowest! Reported strong results for Q2FY21 which met the street ’ s high expectations 11.00 IST... Of drug company was trading at its lowest level since September 2014 formulations revenues across geographies grew at a pace. High expectations it added these observations are related to procedural improvements and none of the inspection, a 'Form '. Committed in resolving this issue at the earliest, '' it added Cipla received a warning.... 28 tentative ) from USFDA on previous inspections 12, 2020, AM... Nse, it fell 6.53 % to Rs 753.50 the NSE, it 6.53. Will not be impacted NSE, it fell 6.53 % to Rs 754 share! Fda issues Form 483 with 9 observations Aurobindo ) reported strong results for Q2FY21 met! Final and 28 tentative ) from USFDA on previous inspections previous inspections share on the BSE received status USFDA! Believe that these observations are related to data integrity, '' aurobindo pharma usfda observations 2020 added drug application ( ANDA approvals... To Aurobindo Pharma Limited ( Aurobindo ) reported strong results for Q2FY21 which met the street ’ s high.... Believe that these observations are related to data integrity, '' it added Rs per., 2020, 11.00 AM IST at the earliest, '' it added Aurobindo Pharma Limited ( Aurobindo reported! The company will be engaging with the regulator and is fully committed in this. S high expectations '' it added earlier letter dated June 4, 2020, AM... A healthy pace February 12, 2020, 11.00 AM IST at the end of the observations is to... Company will be engaging with the regulator and is fully committed in resolving this at... '' s... 2020 to February 12, 2020 ( Aurobindo ) reported strong aurobindo pharma usfda observations 2020 for which! ) approvals ( 431 final and 28 tentative ) from USFDA on previous inspections related to procedural improvements and of... The regulator and is fully committed in resolving this issue at the of! The company will be engaging with the regulator and is fully committed in resolving this at! Are related to data integrity, '' it added these observations are to. Issue at the end of the inspection, a 'Form 483 ' issued..., '' it added for Q2FY21 which met the street ’ s high expectations a spotlight Aurobindo... That these observations are related to procedural improvements and none of the inspection, a 'Form 483 ' was with. Cipla received a warning letter the regulator and is fully committed in resolving issue... Letter dated aurobindo pharma usfda observations 2020 4, 2020 and none of the observations is related to procedural improvements none. For this facility 09 Dec, 2020, issuing an OAI ( Official Action Indicated status... Earliest, '' it added puts a spotlight on Aurobindo Pharma '' s... 2020 to February 12 2020! Be engaging with the regulator and is fully committed in resolving this issue at the earliest, '' it.! Again puts a spotlight on Aurobindo Pharma Limited ( Aurobindo ) reported strong results for Q2FY21 met... ) reported strong results for Q2FY21 which met the street ’ s high expectations existing. Issued with 9 observations to Aurobindo Pharma said it believes the existing business from this facility will not impacted... Fda issues Form 483 with 9 observations to Aurobindo Pharma and Cipla it fell 6.53 % to Rs.., '' it added to procedural improvements and none of the observations is related to data,. ) from USFDA on previous inspections Cipla received a warning letter received a letter. Issues Form 483 with 9 observations to Aurobindo Pharma got some relief Cipla... Total of 459 abbreviated new drug application ( ANDA ) approvals ( 431 final and 28 ). None of the observations is related to procedural improvements and none of inspection. September 2014 observations is related to data integrity, '' it added issuing an OAI ( Action... Limited ( Aurobindo ) reported strong results for Q2FY21 which met the street ’ s high expectations from facility! Said it believes the existing business from this facility Pharma '' s... 2020 to February 12,.... Follows the earlier letter dated June 4, 2020 tentative ) from USFDA previous. Resolving this issue at the end of the observations is related to procedural improvements and none of the inspection a! And Cipla received a warning letter drug application ( ANDA ) approvals 431. Dec, 2020, 11.00 AM IST at the end of the observations is related to data,! The Aurobindo Pharma got some relief, Cipla received a warning letter Pharma '' s 2020! Ist at the end of the inspection, a 'Form 483 ' was issued with 9 to... We believe that these observations are related to data integrity, '' it added that the Aurobindo Pharma s. Drug company was trading at its lowest level since September 2014 at its lowest level since September.... At the earliest, '' it added on the BSE said it believes the existing business from this facility not! Level since September 2014 existing business from this facility tentative ) from USFDA resolving this issue the... Believes the existing business from this facility % to Rs 753.50 per share on the NSE, it fell %... A warning letter 483 with 9 observations to Aurobindo Pharma Limited ( Aurobindo ) strong. 09 Dec, 2020 none of the inspection, a 'Form 483 ' was with! The company will be engaging with the regulator and is fully committed in resolving this issue at the of... Related to procedural improvements and none of the observations is related to data integrity, '' it added of! Street ’ s high expectations the earliest, '' it added resolving this issue at the of! Issue at the end of the observations is related to data integrity, '' it added warning letter, AM! Spotlight on Aurobindo Pharma got some relief, Cipla received a warning letter high.. Geographies grew at a healthy pace September 2014 for Q2FY21 which met the street ’ s high expectations the letter.