Page 7 - Aurobindo Pharma

Aurobindo Pharma receives EIR from USFDA for its Andhra Pradesh facility

Aurobindo Pharma Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility at Pydibhimavaram in Andhra Pradesh. The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the US Food and Drug Administration (USFDA) in February 2019 and issued a warning letter in June 2019. It was inspected further by the USFDA from July 25 to August 2, 2022 and issued a Form 483 with three observations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "Subsequent to our responses for the aforesaid observations, we have received an EIR classifying the inspection as Voluntary Action Indicated (VAI) from the USFDA and with this, the inspection at our Unit XI is concluded," Aurobindo Pharma said in a ...

Aurobindo Pharma slips 7%, hits over 2-year low on weak Q2 results

The company said the second quarter performance was subdued mainly due to the macro-environment factors and higher competitive intensity for some products in the US

Aurobindo Pharma Q2 net down 41% to Rs 409 cr, revenue dips to Rs 5,739 cr

Aurobindo Pharma on Saturday reported a 41 per cent decline in its consolidated net profit at Rs 409 crore for the second quarter ended September 30, 2022. The Hyderabad-based drug firm had posted a net profit of Rs 697 crore in the July-September period of last fiscal. Revenue from operations also declined to Rs 5,739 crore in the September quarter as against Rs 5,942 crore in the year-ago period. Aurobindo Pharma Vice-Chairman and Managing Director K Nithyananda Reddy said the company's second quarter performance was subdued, mainly due to macro-environment factors and higher competitive intensity for some products in the US. "However, we are confident that our robust pipeline of new products will provide impetus to the future growth trajectory," he added. Reddy noted that company's continued focus on biosimilars, R&D, innovation and increasing manufacturing capacity will enhance its product offerings in various markets. "We are confident that, the right measures and growth-le

Delhi excise policy case: Two top execs of private firms held by ED

The ED has arrested two company executives linked to liquor trade in the money laundering investigation being conducted by it into the now scrapped Delhi Excise policy case, official sources said Thursday. Benoy Babu of Pernod Ricard and Sharath Reddy of Aurobindo Pharma have been arrested under sections of the Prevention of Money Laundering Act (PMLA), they said. The Enforcement Directorate (ED) has conducted multiple raids in this case so far. In September, it arrested Sameer Mahandru, managing director of a liquor manufacturing company Indospirit. The agency early this month raided the premises of a PA of Delhi Deputy chief minister Manish Sisodia and later questioned him at its office in Delhi. The money laundering case stems from a CBI FIR that had named Sisodia as an accused among others. The CBI had raided the premises of the deputy chief minister and some Delhi government bureaucrats after filing the case. The excise scheme came under the scanner after the Delhi LG recomm

Aurobindo Pharma slumps 6% amid reports of Sarath Reddy's arrest by ED

According to reports, ED has arrested Sarath Reddy, director of Aurobindo Pharma, under the money laundering act in the now scrapped Delhi Excise policy case.

Aurobindo units recall products in US market for manufacturing issues

Aurobindo Pharma units are recalling different products in the US market for manufacturing lapses, as per the US health regulator. According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), New Jersey-based Aurobindo Pharma USA Inc is recalling 9,504 bottles of Quinapril and Hydrochlorothiazide tablets. The affected lot of the medication, which is used to treat high blood pressure, has been manufactured in India and marketed in the US market by Aurobindo Pharma USA, Inc. As per the USFDA, the company is recalling the affected lot due to "Current good manufacturing practices CGMP deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit." Nitrosamines are a group of compounds which can damage DNA in the long term. The company, a unit of Hyderabad-based Aurobindo Pharma, initiated the Class II voluntary recall on October 5 this year. In a separate statement, USFDA said AuroMedics Pharma LLC, a unit of Aurobindo Phar

Dr Reddy's, Cipla, and Aurobindo units recall products in US market

Leading drug firms Dr Reddy's Laboratories, Cipla and Aurobindo Pharma are recalling different products in the US market for various issues, according to the US Food and Drug Administration. As per the enforcement report by the US Food and Drug Administration (USFDA), the US-based unit of Dr Reddy's Laboratories is recalling 2,838 ampules of vitamin K deficiency treatment drug Phytonadione Injectable Emulsion. According to the USFDA, Dr Reddy's Laboratories is recalling the affected lot due to "failed stability specifications". "Out of specification results reported at 12-month stability testing for aluminum content," it stated. Dr Reddy's initiated the Class III voluntary recall on September 14 this year. As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". USFDA further said the US-based arm of domestic drug major Cipla is recalling 9,041 cartons of Arformoterol ..

Aurobindo slips 6% in a week after arm receives EIR from USFDA

In the past six months, Aurobindo has underperformed the market by falling 31 per cent, as compared to a marginal 0.07 per cent decline in the S&P BSE Sensex.

Sensex, Nifty end flat post volatile trade; ITC up 2%; Maruti, RIL dip 1%

CLOSING BELL: ITC, the biggest cigarette maker, and the second largest fast moving consumer goods (FMCG) company in India, regained the market capitalisation of Rs 4 trillion on Friday

Aurobindo Pharma's arm to invest around Rs 300 cr for capacity expansion

Aurobindo Pharma on Thursday said its wholly-owned arm, CuraTeQ Biologics, plans to invest around Rs 300 crore on capacity expansion of biologics manufacturing facilities. The board of directors of CuraTeQ Biologics Pvt Ltd, at its meeting held on Thursday, approved the expansion of its operations by establishing another mammalian cell culture manufacturing facility of higher capacity to cater to the future requirements, Aurobindo Pharma said in a regulatory filing. "The capital expenditure for ramping up capacities is estimated to be around Rs 300 crore," it said, adding that the facility is likely to be fully operational by FY26. Further, the board also approved entering into contract manufacturing operations (CMO) for biologicals for effective utilisation of capacities. This would augment the business prospects in this area as the global biologics contract manufacturing demand is growing at 8-10 per cent and CuraTeQ will actively seek customers in CMO area, it added. The compan

Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 of Raleigh-based plant which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing. The plant is owned by Aurolife Pharma LLC, a wholly-owned step down subsidiary of the company, it added. "At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues," Aurobindo Pharma said. The company will respond to the USFDA within the stipulated timeline, it added. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its

USFDA approves Aurobindo Pharma owned Eugia's generic Vasopressin injection

Aurobindo Pharma Ltd on Tuesday said its wholly-owned arm Eugia Pharma Specialties Ltd has received final approval from the US health regulator for its generic version of Vasopressin injection

Aurobindo Pharma Q1 net profit down by 32% to Rs 520.5 cr; revenue up 9.4%

K Nithyananda Reddy, Vice-Chairman and Managing Director of the company said, investments in product portfolio continued at a healthy pace as reflected in the filings and launches in the quarter."

Sensex up 515 pts, Nifty tops 17,650 on lower-than-expected US inflation

CLOSING BELL: Easing CPI figures reduced the probability of a 75-bps rate hike in the upcoming US FOMC meeting

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Aurobindo Pharma's Andhra unit gets Form 483 with 3 USFDA observations

Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing. Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 2, 2022. "At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related ..

Rupee breaches 80: Watch out these levels on forex-sensitive Infy, IndiGo

Among select export-oriented shares, Aurobindo Pharma seems well placed on the charts with a potential upside of 9 per cent in the near term.

Aurobindo Pharma to develop complex products, expand global footprint

Aurobindo Pharma remains focused on developing complex and differentiated products in multiple areas to drive the next phase of growth

Sensex, Nifty end flat after volatile session; metal, energy stocks shine

CLOSING BELL: M&M, Tech M, Dr Reddy's Labs, Reliance Industries, HCL Tech, and Tata Steel were the top gainers on the 30-pack index

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