Amneal Pharmaceuticals

Amneal Expands Broad Injectables Portfolio to Over 40 Products with the Addition of Six New Therapies

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水曜日, 6月 5, 2024
General Health, Health, Pharmaceutical, Medical Supplies, Oncology, Amneal Pharmaceuticals, Pharmacy, Patient, Investment

Amneal has made meaningful investments to expand our capacity and capabilities and deliver on our goal to be a significant injectables player.

Key Points: 
  • Amneal has made meaningful investments to expand our capacity and capabilities and deliver on our goal to be a significant injectables player.
  • Importantly, we are building a robust portfolio of injectables that can serve as a reliable solution to market shortages.
  • Amneal has tripled its injectables capacity to 60 million units across four manufacturing facilities over the past few years and expects to have over 60 commercial injectable products in 2025.
  • Amneal expects to launch two to three new 505(b)(2) injectables per year going forward.

Amneal to Participate at Upcoming Investor Conference

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水曜日, 5月 22, 2024
Medical Devices, Medical Supplies, Public Relations, Investor Relations, Communications, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Medication, Chirag, Webcast, Conference, Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 2024 Jefferies Healthcare Conference on June 5, 2024.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 2024 Jefferies Healthcare Conference on June 5, 2024.
  • Chirag will present at 1:30 PM EST.
  • A live webcast of the presentation will be accessible on the Company's website at https://investors.amneal.com .
  • A replay of the webcast will be available following the event.

Amneal Begins Supplying Over-the-Counter Naloxone Hydrochloride Nasal Spray to U.S. Retail Pharmacies and the State of California

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水曜日, 5月 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Food, Naloxone, Medication, Pharmacy, SVP, Amneal Pharmaceuticals, OTC, USP, Government

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California.
  • The U.S. Food and Drug Administration approved Amneal’s Naloxone HCI Nasal Spray in April 2024.
  • Amneal’s Naloxone HCI Nasal Spray is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses.
  • The Company also entered into a distribution agreement with California to provide Naloxone HCI Nasal Spray through the CalRx® Naloxone Access Initiative.

Amneal Reports First Quarter 2024 Financial Results

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金曜日, 5月 3, 2024
General Health, Pharmaceutical, Health, Table, Naloxone, Emergency, Native, Patient, Medication, GAAP, Amneal Pharmaceuticals, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.
  • “We are extremely pleased with our outstanding start to the year, as Amneal generated record levels of revenues in the first quarter.
  • Net revenue in the first quarter of 2024 was $659 million, an increase of 18% compared to $558 million in the first quarter of 2023.
  • Adjusted diluted earnings per share in the first quarter of 2024 was $0.14 compared to $0.12 for the first quarter of 2023.

Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine

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火曜日, 4月 16, 2024
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Radiation, CMS, Pharmacy, Refrigeration, Hospital, Pembrolizumab, Cisplatin, Aplastic anemia, Mesothelioma, Disease, Restrictive lung disease, Pemetrexed, Patient, Medicare, Kidney, ALK, Medication, Amneal Pharmaceuticals, RTU, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.
  • This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
  • “The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.
  • PEMRYDI RTU® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.

Amneal to Report First Quarter 2024 Results on May 3, 2024

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水曜日, 4月 10, 2024
Biotechnology, General Health, Pharmaceutical, Health, Medication, Amneal Pharmaceuticals, PIN

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its first quarter 2024 financial results on Friday, May 3, 2024, prior to market open.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its first quarter 2024 financial results on Friday, May 3, 2024, prior to market open.
  • The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
  • Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call.
  • A replay of the conference call will be posted shortly after the call and will be available for seven days.

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

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月曜日, 3月 25, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, AOE, Otitis externa, Patient, Dexamethasone, Ciprofloxacin, Abbreviated New Drug Application, Pseudomonas aeruginosa, Medication, Infection, Staphylococcus aureus, Amneal Pharmaceuticals, Food

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

Amneal Reports Fourth Quarter and Full Year 2023 Financial Results

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金曜日, 3月 1, 2024
Health, General Health, Growth, Medication, EPS, Generic, Amneal Pharmaceuticals, Research, Specialty, Investment

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2023.
  • Net revenue in the fourth quarter of 2023 was $617 million, an increase of 1% compared to $610 million in the fourth quarter of 2022.
  • Adjusted EBITDA(1) in the fourth quarter of 2023 was $142 million, a decrease of 8% compared to the fourth quarter of 2022, primarily due to investments in research and development and commercial to drive future growth.
  • Adjusted diluted EPS(1) in the fourth quarter of 2023 was $0.14, a decrease of 39% from $0.23 in the fourth quarter of 2022.

Amneal to Participate at Upcoming Investor Conference

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火曜日, 2月 13, 2024
Health, Other Science, General Health, Research, Science, Pharmaceutical, Biotechnology, Medication, Amneal Pharmaceuticals, Webcast

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer, will participate in the following investor conference.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer, will participate in the following investor conference.
  • A live webcast of the presentation will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com .
  • A replay of the webcast will be posted shortly after the presentation and will be available for 90 days following the event.

Deb Autor, Former FDA Deputy Commissioner, Appointed CEO of Healthcare Innovation Catalysts

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木曜日, 2月 1, 2024
Research, General Health, Professional Services, Pharmaceutical, Medical Devices, Health Technology, Data Analytics, Science, Biotechnology, Practice Management, Consulting, Health, Partnership, Multimedia, Policy, ABC, CNN, NBC, Knowledge, Government, Mylan, USA Today, FDA, Justice, Amneal Pharmaceuticals, AstraZeneca, Food, The New York Times, CBS, Congress, The Wall Street Journal, Los Angeles Times, Medicine, HIC, Organization

Her government career spanned two decades, culminating in the crucial role of Deputy Commissioner of FDA where she oversaw all inspections and international operations.

Key Points: 
  • Her government career spanned two decades, culminating in the crucial role of Deputy Commissioner of FDA where she oversaw all inspections and international operations.
  • Before FDA, Ms. Autor was a decorated federal prosecutor at the U.S. Department of Justice, and FDA was her client.
  • “We are honored to have Deb take the helm as our first CEO,” stated Michael Singer, Executive Chairman of HIC.
  • Since 2018, she has served as Chair of the FDA Alumni Association, where she continues to work to support the agency’s mission.