Page 6 - Aurobindo Pharma

Aurobindo's Andhra plant receives 1 observation from USFDA after inspection

Aurobindo Pharma on Wednesday said the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. The US Food and Drug Administration (US FDA) inspected the Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing. At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added. "We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest," Aurobindo Pharma stated. As per the USFDA a 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. Shares of Aurobindo Pharma were trading ...

Aurobindo Pharma to launch HIV drug for children in 123 countries

The pharmaceutical company will launch its HIV triple combination product for children living with HIV in low- and middle-income countries under voluntary licence from ViiV Healthcare

Aurobindo Pharma gets USFDA nod to make, market generic Icatibant injection

Aurobindo Pharma on Wednesday said its wholly-owned arm Eugia Pharma Specialities has received final approval from the US health regulator to manufacture and market generic Icatibant injection used in treatment of hereditary angioedema. The approval granted by the US Food & Drug Administration (USFDA) is for Icatibant injection of strength 30 mg/3 mL (10 mg/mL), single-dose pre-filled syringe, Aurobindo Pharma said in a regulatory filing. It is the bioequivalent and therapeutically equivalent of reference listed drug FIRAZYR (Icatibant injection) by Takeda Pharmaceuticals USA Inc, it added. "The product is being launched in September 2023," Aurobindo Pharma said. The approved product has an estimated market size of around USD 137 million for the 12 months ended June 2023, the company said citing IQVIA data.

Aurobindo Pharma profit increases 10% at Rs 571 cr in June quarter

Aurobindo Pharma on Saturday said its consolidated net profit increased 10 per cent to Rs 571 crore in the first quarter ended June 30, 2023, on account of robust sales across regions. The drug firm had reported a net profit of Rs 520.5 crore in April-June 2022-23. Revenue from operations rose to Rs 6,850.5 crore from Rs 6,236 crore in the year-ago period, the Hyderabad-based firm said in a statement. With the product pipeline continuing to advance, and execution of growth drivers proceeding as planned, the company is confident that its fundamental strengths position it to create an upward trajectory, Vice-Chairman and Managing Director K Nithyananda Reddy said. "Looking ahead, we are confident in executing our growth initiatives and creating long-term value for our shareholders," Reddy said.

Aurobindo Pharma hits 2-year high; stock zooms 100% thus far in 2023

Aurobindo said its subsidiary Eugia has received a final approval from the USFDA to manufacture and market Vancomycin Hydrochloride for Injection used in treatment of skin and bone infection.

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Aurobindo Pharma arm signs pact with Medicines Patent Pool to develop drug

Aurobindo Pharma on Friday said its wholly-owned arm, Eugia Pharma Specialities Ltd has entered into a voluntary sub-licensing agreement with Medicines Patent Pool (MPP) to develop and market an anti-cancer drug. The sub-licensing agreement for Nilotinib capsules, originally developed by Novartis, will be in 44 low and middle-income countries (LMIC), including the seven countries where patents on the product are pending or in force, Aurobindo Pharma said in a regulatory filing. Nilotinib capsules are used for treatment of chronic myeloid leukemia. "These are the first sub-licence agreements that MPP has signed for a cancer treatment that will be made available in the LMIC, through this licence. This product will be a good addition to Aurobindo's Oncology portfolio and will further strengthen our leadership in the generic Oncology medicine space," Aurobindo Pharma Vice Chairman & Managing Director K Nithyananda Reddy said. He further said,"We are looking forward to start supplying .

Aurobindo Pharma's P Sarath Reddy becomes approver in Delhi liquor case

ED said that Reddy will voluntarily disclose all the irregularities in making as well as implementing the liquor policy in Delhi

Aurobindo hits 52-week high; zooms 63% from Feb low on improved performance

Analysts believe Aurobindo has multiple growth drivers in place with investments in vaccines, injectables, biosimilars and PLI, which are expected to be reflected from FY24

Inverse H&S in pharma index could revive a positive bias for short-term

Pharma shares like Aurobindo Pharma, Zydus Lifesciences, Sun Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals may rise up to 14 per cent.

Aurobindo Pharma's consolidated net profit down 18.7% at Rs 491 Cr in Q3

Aurobindo Pharma Limited on Thursday said its consolidated net profit for the quarter ended January 31 was down by 18.7 per cent to Rs 491.2 crore against Rs 604.3 crore in Q3FY22. A press release from the drug maker said revenue from operations during the quarter under discussion was up by 6.7 per cent to Rs 6,407.10 crore against Rs 6,002.2 in the same period last fiscal. Commenting on the company's performance, K Nithyananda Reddy, Vice-Chairman and Managing Director of the company said "We witnessed an improved momentum backed by recovery across our business verticals and our endeavor is to continuously innovate and differentiate." In line with the companys commitment to innovate, there is an increase in the investments in Biosimilars. The company aims to sustain the momentum with new launches, improved cost efficiencies and adherence to the highest standards of compliance, supported by strong execution, he further said. During the quarter, formulation revenue increase by 9.2

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Mehul Kothari recommends Biocon, Aurobindo Pharma for trading gains

According to the technical analyst from Anand Rathi, Aurobindo Pharma can rally to Rs 490; while Biocon can jump to Rs 295.

Aurobindo unit, Evive Biotech ink pact to sell CIN treatment product in US

Aurobindo Pharma on Wednesday said its unit has entered into a licensing pact with Evive Biotech to commercialise Ryzneuta in the US market. The product, a novel dimeric G-CSF long-acting fusion protein without pegylation, is currently under late-stage review by the US Food and Drug Administration for chemotherapy-induced neutropenia (CIN). In addition to the US health regulator, Evive's Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta are currently under review by European and Chinese regulators. Neutropenia is a common side-effect of chemotherapy and is a condition characterised by low levels of neutrophils, a type of white blood cell that fights infection. The licensing pact has been inked between Evive and Acrotech Biopharma (Acrotech), a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc, Aurobindo Pharma said in a statement. As part of the agreement, Evive will be responsible for the ongoing development, manufacturi

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Aurobindo Pharma aims to complete Rs 2,000 Cr Pen-G plant in AP by March'24

Aurobindo Pharma's aims to complete its Rs 2,000 crore Penicillin G (Pen G) plant in Andhra Pradesh by March 2024 even as the trial or the pilot batches will take place starting October next year onwards, S Subramanian, Chief Financial Officer, Aurobindo Pharma has said. Replying to a query during the recent earnings call, he said the overall project of USD 235 million, the major will be to put a de-salination plant, the fermentation process, power blocks, among others and multiple subprojects are being done with purchase orders been issued. "So, we believe by next September or October, the installation should be over. After that, the trial or the pilot batches will take place starting October next year onwards. So, our target is to complete the projects by March'24 and it's our endeavour to advance it," Subramanian said. "The material is expected to be received in this quarter and the next quarter and significant portions of the buildings and blocks have been done," he further ...

Pvt banks, IT drag Sensex 230pts down, Nifty below 18,350; Paytm tanks 10%

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Stocks to watch today: Aurobindo Pharma received EIR from USFDA for its manufacturing facility in Andhra Pradesh; Softbank plans to offload around 29 million shares of Paytm via block deals

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 ...