Page 2 - Aurobindo Pharma

Lupin, Eugia recall products from US over manufacturing issues: USFDA

Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections. Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications". The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh. The company commenced the Class II nationwide (US) recall on May 30 this year. The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP. The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said. Eugia com

Aurobindo arm TheraNym inks pact with MSD for biologics manufacturing

This agreement follows previous disclosures by Aurobindo Pharma about expanding its biologics manufacturing facilities and exploring contract manufacturing operations (CMO) for biologicals

Aurobindo Pharma stock news: Analysts are bullish despite OAI to Eugia unit

Analysts say that despite OAI on Eugia unit-III, Aurobindo Pharma's Vizag facility may play a back up for unit-III and for new ANDA filings contributing to growth in FY26

Aurobindo Pharma Q4 results: PAT rises 79.5% to Rs 908 cr, revenue up 14.8%

The increase in PAT is attributed to expansion into the new markets, product launches and stable pricing

Drug makers Dr Reddy's, Sun Pharma, Aurobindo recall products in US market

Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Princeton (New Jersey) based Dr Reddy's Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a "Sub-potent Drug", USFDA stated. The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal ...

Aurobindo Pharma gets tax demand of over Rs 13 cr from Hyderabad officials

Aurobindo Pharma Ltd on Friday said it has received tax demand of over Rs 13 crore, including interest and penalty, from the GST authority over ineligible input tax credit claim. The Deputy Commissioner (ST) STU-1 of GST, Punjagutta Division, Hyderabad, Commercial Taxes Department, Telangana, has passed an order under relevant provisions of the Central Goods and Services Tax Act, 2017 and TGST Act 2017 for the FY 2018-19 to this effect. The order demanded reversal of ITC and payment of GST amounting to Rs 6,54,50,645 along with interest of Rs 5,92,20,900 and penalty of Rs 65,51,354, Aurobindo Pharma said in a regulatory filing. It claims ineligible ITC and orders reversal of ITC and demanding GST along with interest, the company added. The company intends to file an appeal before appellate authority, Aurobindo Pharma said, adding there is no material impact on its financials or operations due to the order.

Aurobindo Pharma commissions 4 plants in Andhra including Pen-G facility

Aurobindo Pharma on Monday said it has commissioned four state-of-the-art manufacturing facilities for Penicillin-G, 6-Amino Penicillanic Acid (6-APA), Injectable products and Granulation, through its wholly owned subsidiaries. Penicillin-G (Pen-G) facility, located in a SEZ at Kakinada in Andhra Pradesh, has a production capacity of 15,000 tonne per annum and also 1.8 lakh tonne of gulcose, while 6-Amino Penicillanic Acid plant has a capacity to produce 3,600 tonne annually, the drug maker said in a press release. The Rs 2,400 crore Pen-G plant is expected to start trial production in April and commercial production in a couple of months and the ramping up of the production will happen during the second quarter of the current fiscal, a senior official of the city-based drug maker had earlier said. The plant was approved under the Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/Drug Intermediates and Active .

BJP biggest beneficiary of Aurobindo Pharma's Rs 52 cr electoral bonds

Aurobindo Pharma, one of whose directors was arrested in the Delhi liquor scam, had bought electoral bonds for a total of Rs 52 crore with more than half of it going to the Bharatiya Janata Party, according to data released by the Election Commission. The Hyderabad-based firm had purchased electoral bonds between April 3, 2021 to November 8, 2023 and Rs 34.5 crore was donated to the Bharatiya Janata Party (BJP), Rs 15 crore to the Bharat Rashtra Samithi (BRS), and Rs 2.5 crore to the Telugu Desam Party (TDP). The drug maker purchased electoral bonds worth Rs 5 crore on November 15, 2022 five days after one of its directors, P Sarath Chandra Reddy was arrested for involvement in money laundering linked to the controversial Delhi excise policy, which has been scrapped. Comments from the company could not be obtained. As per the Election Commission data, BJP encashed this sum on November 21, 2022. Last year in June, Reddy turned approver in the case after a Delhi court allowed him to

Aurobindo Pharma to start production of Pen-G at its Andhra plant in Q1FY25

Aurobindo Pharma expects its Rs 2,400 crore Pen-G (penicillin) plant in Andhra Pradesh to start trial production in April and commercial production in a couple of months and ramping up of production will happen during the second quarter of next fiscal, a senior official of the city-based drug maker has said. Santhanam Subramanian, Chief Financial Officer of Aurobindo Pharma, also said the company is constructing a total of 10 new facilities which are expected to capitalise in the next one to two years. Currently, the firm has a total of 25 manufacturing and packaging facilities at various locations. The plant, which was approved under Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the country, will have a production capacity of around 15,000 tonnes annually. "We are doing the Pen-G project. We are in the process of installation and ...

Aurobindo Pharma Q3 results: Profit up 91.43%, revenue rises 14.7%

The company's revenue from formulations increased by 17.2 per cent Y-o-Y to Rs 6,291 crore. Sequentially, it was up by 5.4 per cent from Rs 5,968 crore in Q2 FY24

Aurobindo Pharma sinks 10% as formulation unit undergoes US FDA inspection

The inspection is under progress from January 22, 2024 and has not been concluded yet. Eugia Pharma is the company's injectables arm

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Aurobindo Pharma gets USFDA approval for generic antifungal injection

Aurobindo Pharma Ltd on Wednesday said its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US health regulator to manufacture and market generic Posaconazole injection used to prevent serious fungal infections. The approval by the US Food & Drug Administration (USFDA) is for Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck), it added. "The product is expected to be launched in December 2023," the company said. Posaconazole injection, 300 mg/16.7 mL (18 mg/mL), single-dose vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised due to certain conditions, it added. The approved ...

Aurobindo Pharma's new injectable facility get 10 observations from US FDA

"The observations are procedural and will be responded to within the stipulated time," the company stated in a regulatory filing

Aurobindo Pharma gets 'Voluntary Action Indicated' classing from US FDA

The classification follows an inspection conducted by the FDA from September 13 to September 19, 2023

Aurobindo Pharma unit gets USFDA nod to market generic asthma medication

Aurobindo Pharma on Thursday said its subsidiary has received approval from the US health regulator to market a generic medication to treat asthma in children. Eugia Pharma Specialities, a wholly-owned subsidiary of the company, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, the Hyderabad-based drug firm said in a regulatory filing. The company's product is therapeutically equivalent to Astrazeneca Pharmaceuticals LP's Pulmicort Repsules Inhalation Suspension, it added. The product, indicated for treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years, is expected to be launched in FY25, Aurobindo Pharma said. As per IQVIA data, the approved product has an estimated market size of USD 226.4 million for the 12 months ended September 2023. Shares of Aurobindo Pharma were trading 1.51 per cent up at 1,036.55 apiece on the BSE.

Aurobindo Pharma receives USFDA approval to manufacture Darunavir tablets

Darunavir Tablets, 600 mg, and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of (HIV-1) infection in adult and pediatric patients 3 years of age and older

Ryzneuta for chemotherapy-induced neutropenia receives USFDA approval

Acrotech Biopharma is preparing to commercialise Ryzneuta in the United States in the near future

Aurobindo Pharma subsidiary receives USFDA approval for Ryzeneuta

It helps to enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy

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