Amneal Pharmaceuticals

Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023

Retrieved on: 
Thursday, January 4, 2024
Medical Supplies, Other Retail, Clinical Trials, Specialty, Biotechnology, Health, Pharmaceutical, General Health, Retail, Amneal Pharmaceuticals, Capsule, Medication, Valsartan, Tranexamic acid, Spironolactone, Senior, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022.
  • In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables.
  • New injectable products added include potassium phosphate vials, tranexamic acid and esmolol intravenous bags.
  • In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets, and icosapent capsules.

FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book

Retrieved on: 
Wednesday, January 3, 2024
Federal Trade Commission, Policy, Food, Orange Book, AstraZeneca, FDA, Blog, The Orange Book, NDA, Boehringer Ingelheim, News, Asthma, New Drug Application, Patent, FTC, Social media, Investment, Amneal Pharmaceuticals, Commission, Epinephrine autoinjector, AbbVie, Delays

“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.

Key Points: 
  • “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.
  • “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens.
  • Last month, the FTC issued a policy statement that warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book.
  • Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law.

AMNEAL INVESTIGATION NOTICE: Kaskela Law LLC Announces Shareholder Investigation of Amneal Pharmaceuticals, Inc. (NYSE: AMRX) and Encourages Investors with Losses to Contact the Firm

Retrieved on: 
Wednesday, December 27, 2023
Acquisition, Amneal Pharmaceuticals

PHILADELPHIA, Dec. 27, 2023 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) on behalf of the Company’s shareholders.

Key Points: 
  • PHILADELPHIA, Dec. 27, 2023 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) on behalf of the Company’s shareholders.
  • The investigation seeks to determine whether Amneal and/or the company’s representatives violated the securities laws by issuing false and/or misleading statements and failing to disclose material information to the company’s investors.
  • Amneal shareholders are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq.
  • Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation.

CorMedix Inc. Announces Appointment of Chief Legal Officer

Retrieved on: 
Friday, December 15, 2023
Amherst College, Amneal Pharmaceuticals, FDA, Legal Affairs, Actavis, Civil Service (United Kingdom), Assistant, King Pharmaceuticals, EVP, Corporation

as EVP, Chief Legal Officer, and Corporate Secretary, effective December 12, 2023.

Key Points: 
  • as EVP, Chief Legal Officer, and Corporate Secretary, effective December 12, 2023.
  • Ms. Zelnick Kaufman has more than two decades of legal, compliance and operations experience in the life sciences industry.
  • Prior to joining CorMedix, she most recently served as Chief Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals, a specialty and generic pharmaceuticals company.
  • “We are excited to welcome Beth to the CorMedix team at such an exciting time for the company,” said Joseph Todisco, Chief Executive Officer of CorMedix.

Amneal to Participate at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, December 21, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Webcast, Conference, Medication, Amneal Pharmaceuticals, Chirag

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on January 9-10, 2024.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on January 9-10, 2024.
  • Chirag will present on January 10th at 11:15 AM PST, and a live webcast will be accessible on the Company's website at https://investors.amneal.com .
  • A replay of the webcast will be available for 30 days following the event.

Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)

Retrieved on: 
Thursday, December 7, 2023
Health, Neurology, General Health, Research, Pharmaceutical, Science, COMT, Medicine, Capsule, Sleep, Aggression, BIAL, Brain, Behavior, NYSE, Hormone, Senior, Food, Parkinson's disease, Eating, Movement, Gambling, Liver, PD, Delusion, Hallucination, Constipation, Sleep disorder, Patient, Multimedia, Dopamine, Dobutamine, Carbidopa, Behavior informatics, FDA, Isocarboxazid, Isoprenaline, Catecholamine, Vitamin, Partnership, Norepinephrine, Carbidopa/levodopa, Adrenaline, L-DOPA, Phenelzine, Mouth, Hearing, Physician, Neoplasm, Dyskinesia, Medication, Somnolence, Accident, Dizziness, Tranylcypromine, Weight loss, Psychosis, Pharmaceutical industry, Birth control, S.A, Amneal Pharmaceuticals, LD

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.
  • Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s.
  • ONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time.
  • The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance.

Amneal Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Pharmaceutical, Health, Bank statement, Adjustment, GAAP, Acquisition, Amneal Pharmaceuticals

See also “Non GAAP Financial Measures” below.

Key Points: 
  • See also “Non GAAP Financial Measures” below.
  • The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
  • These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.
  • Amneal will host a conference call and live webcast at 8:30 am Eastern Time on November 7, 2023 to discuss its results.

Amneal to Report Third Quarter 2023 Results on November 7, 2023

Retrieved on: 
Thursday, October 5, 2023
Biotechnology, Pharmaceutical, Health, PIN, NYSE, Amneal Pharmaceuticals, Medication

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that the Company will release its third quarter 2023 financial results on Tuesday, November 7, 2023, prior to market open.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that the Company will release its third quarter 2023 financial results on Tuesday, November 7, 2023, 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 First Product Approval in China

Retrieved on: 
Wednesday, September 6, 2023
Health, FDA, Other Health, General Health, Research, Science, Pharmaceutical, Fosun Pharma, Fosun International, Medication, Emerging market, Patient, Growth, NYSE, Fine chemical, Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China.
  • In total, Amneal has 6 products pending review in China with more product registrations planned over time.
  • In Europe, China, and other countries, Amneal is collaborating with distribution partners to bring Amneal’s U.S. FDA approved product portfolio around the world.
  • “Sevelamer becomes our first product approval in China and our initial entry into the second largest pharmaceutical market in the world.

Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in India

Retrieved on: 
Tuesday, August 29, 2023
Manufacturing, Other Manufacturing, Other Health, Health, Pharmaceutical, Commissioner, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Food and Drug Administration, Multimedia, Assistant, Medication, NYSE, FDCA, Patient, Global Affairs Canada, FDA, Food, Automation, Pharmaceutical industry, Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that a delegation of senior members of the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) together with local government officials recently visited the Company’s manufacturing facility in Matoda, India.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that a delegation of senior members of the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) together with local government officials recently visited the Company’s manufacturing facility in Matoda, India.
  • The visit followed the G20 Health Ministers' meeting in Gandhinagar, India on August 18 and 19, where health ministers from around the world met to discuss global health issues.
  • Amneal’s site in Matoda is one of the Company’s 12 pharmaceutical manufacturing facilities.
  • We are proud to participate in this important visit to share our role in delivering safe and effective pharmaceuticals around the world.