ANI PHARMACEUTICALS, INC.


Associated tags: Patient, Health, ANI, Biotechnology, Pharmaceutical, Pharmaceutical industry

Locations: UNITED STATES, NEW YORK CITY, BAUDETTE, MN, US

ANI Pharmaceuticals Announces Launch of Mexiletine Hydrochloride Capsules

Retrieved on: 
Tuesday, June 30, 2020

BAUDETTE, Minn., June 30, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq:ANIP) today announced the launch of Mexiletine Hydrochloride Capsules USP, 150mg, 200mg and 250mg.

Key Points: 
  • BAUDETTE, Minn., June 30, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq:ANIP) today announced the launch of Mexiletine Hydrochloride Capsules USP, 150mg, 200mg and 250mg.
  • The launch represents an important milestone for ANI in the integration of our Oakville, Canada manufacturing site, acquired in August 2018.
  • Mexiletine is the first new ANI product launch from the Oakville site.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Schedules Conference Call to Discuss First Quarter 2020 Financial Results

Retrieved on: 
Thursday, April 30, 2020

BAUDETTE, Minn., April 30, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its first quarter 2020 financial results on Thursday, May 7, 2020, before the opening of the U.S. financial markets.

Key Points: 
  • BAUDETTE, Minn., April 30, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its first quarter 2020 financial results on Thursday, May 7, 2020, before the opening of the U.S. financial markets.
  • Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Thursday, May 7, 2020.
  • The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.

ANI Announces Upcoming Departure of CEO

Retrieved on: 
Tuesday, April 14, 2020

BAUDETTE, Minn., April 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that Arthur S. Przybyl will depart as President and Chief Executive Officer on May 10, 2020.

Key Points: 
  • BAUDETTE, Minn., April 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that Arthur S. Przybyl will depart as President and Chief Executive Officer on May 10, 2020.
  • Since 2009, I have achieved my goals of transforming ANI's business model and growing ANI into the profitable and sustainable business that it is today.
  • Robert E. Brown, Jr., Chairman of the Board of Directors of ANI, said, "On behalf of the entire Board, I would like to thank Art for his many contributions to ANI during his tenure at the Company.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Announces Launch of Omega-3-Acid Ethyl Esters Capsules USP

Retrieved on: 
Thursday, April 2, 2020

BAUDETTE, Minn., April 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram.

Key Points: 
  • BAUDETTE, Minn., April 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram.
  • Arthur S. Przybyl, ANI's President and CEO stated, "This is our fifth generic product launch in 2020.
  • Omega-3-Acid Ethyl Esters Capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500mg per dL) hypertriglyceridemia (HGT).
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Announces Launch of Polyethylene Glycol 3350, 17g/Packet

Retrieved on: 
Thursday, March 26, 2020

BAUDETTE, Minn., March 26, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Polyethylene Glycol 3350, 17g/Packet (PEG-3350).

Key Points: 
  • BAUDETTE, Minn., March 26, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Polyethylene Glycol 3350, 17g/Packet (PEG-3350).
  • This launch represents ANI's fourth new drug introduction in 2020.
  • Polyethylene Glycol 3350 is indicated for the treatment of occasional constipation.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Announces the Filing of a Prior Approval Supplement for Purified Cortrophin® Gel 80 U/mL

Retrieved on: 
Tuesday, March 24, 2020

As part of the PAS, ANI has submitted a comprehensive characterization package which demonstrates an unparalleled understanding of both the API and Cortrophin Gel.

Key Points: 
  • As part of the PAS, ANI has submitted a comprehensive characterization package which demonstrates an unparalleled understanding of both the API and Cortrophin Gel.
  • Arthur S. Przybyl, ANI's President and CEO commented, "Cortrophin Gel represents the last real hope for potential competition for H.P Acthar Gel.
  • ANI has publicly committed to offering Cortrophin Gel at a substantial discount when compared to the current price for H.P Acthar Gel.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Announces FDA Approval of Memantine Hydrochloride Extended-Release Capsules

Retrieved on: 
Monday, March 2, 2020

BAUDETTE, Minn., March 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg.The current annual U.S. market for this product is approximately $127 million, according to IQVIA.

Key Points: 
  • BAUDETTE, Minn., March 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg.The current annual U.S. market for this product is approximately $127 million, according to IQVIA.
  • Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate and severe dementia of the Alzheimer's type.
  • For more information, including the complete list of indications and usages, please see the Full Prescribing Information.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Reports Full Year and Fourth Quarter 2019 Results, Provides 2020 Guidance and Remains on Track to Submit Cortrophin® Gel sNDA to FDA in March 2020

Retrieved on: 
Thursday, February 27, 2020

Operating expenses increased to $52.6 million for the three months ended December 31, 2019, from $45.7 million in the prior year period.

Key Points: 
  • Operating expenses increased to $52.6 million for the three months ended December 31, 2019, from $45.7 million in the prior year period.
  • Cost of sales as a percentage of net revenues increased to37% during the three months ended December 31, 2019, from 35% during same period in 2018.
  • The increase was primarily due to the inventory reserve charges recognized in the fourth quarter 2019 and negative price, which were tempered by reductions related to the 2019 royalty buyout.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.

ANI Pharmaceuticals Schedules Conference Call to Discuss Fourth Quarter and Year-to-Date 2019 Financial Results

Retrieved on: 
Thursday, February 20, 2020

BAUDETTE, Minn., Feb. 20, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets.

Key Points: 
  • BAUDETTE, Minn., Feb. 20, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets.
  • The earnings press release will be accessible through the Investor Relations section of the Company's website, www.anipharmaceuticals.com .
  • The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.

ANI Announces Launch of Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL

Retrieved on: 
Wednesday, February 12, 2020

BAUDETTE, Minn., Feb. 12, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL.The current annual market for this product is approximately $29 million, according to IQVIA.This launch represents ANI's third generic product introduction in 2020.

Key Points: 
  • BAUDETTE, Minn., Feb. 12, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL.The current annual market for this product is approximately $29 million, according to IQVIA.This launch represents ANI's third generic product introduction in 2020.
  • Arthur S. Przybyl, ANI's President and CEO commented, "This is the twelfth product that ANI has successfully launched from our library of discontinued NDAs and ANDAs.
  • Sulfamethoxazole and Trimethoprim Oral Suspension is indicated in the treatment and prevention of various infections proven or strongly suspected to be caused by susceptible bacteria which include urinary tract infections, acute otitis media, bronchitis, shigellosis, Pneumocystis jirovecipneumonia, and traveler's diarrhea.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.