Page 6 - Aurobindo Pharma

Stocks to Watch: Bajaj Auto, Metropolis, Zee Entertainment, Fino Payments

Stocks to Watch on January 9, 2024: Sony Group Corp is planning to call off the merger pact of its India unit with Zee Entertainment, reported Bloomberg

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

Stocks to Watch today: TCS, Strides, Aurobindo, Jio Financial, Titan, BoB

Stocks to watch on Wednesday, November 22, 2023: BHEL, Chambal Fertilizers, Delta Corp, Hind Copper, Indiabulls Housing, India Cements, Manappuram, MCX, NMDC, RBL Bank and Zee are in F&O ban today.

Aurobindo Pharma hits 52-week high, jumps nearly 4% in a weak market

The stock has been one of the top out-performers so far this month, and gained a whopping 18.5 per cent.

Aurobindo Pharma posts 84% jump in Q2 profit on strong overseas demand

India's generic drug makers, which draw a significant share of revenue from the United States, are slowly recovering from the effects of eroding prices in the world's largest drug market

Aurobindo Pharma: Strong prospects offset by valuation concerns

A benign pricing environment in the US and drug shortages are major triggers for the company

Aurobindo Pharma arm receives FDA nod for Testosterone Cypionate injection

According to research firm IQVIA, the approved product has an estimated market size of $226.8 million for the twelve months ending August 2023

Sun Pharma, Aurobindo recall drugs from US market due to mfg issues

Leading drug makers Sun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the US Food & Drug Administration. As per the latest Enforcement Report issued by the American health regulator, a US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market. The medication is used for the treatment of dry eyes. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the product for being "Subpotent', USFDA stated. The company initiated the nationwide (US) Class III recall on September 7 this year. As per the 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". The US health regulator stated that Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's ..

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.

Stocks to Watch: RIL, ICICI Bank, Paytm, IGL, Biocon, YES Bank, Cyient DLM

Stocks to Watch on July 24, 2023: Tata Steel, HDFC AMC, Canara Bank, IDBI Bank, TVS Motor will announce their Q1 results today