Key Points:
- To schedule a 1x1 meeting with the Company, please email: [email protected]
The live and archived webcast will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations.
- The replay of the webcast will be accessible for 30 days.
Retrieved on:
Tuesday, January 23, 2024
BAUDETTE, Minn., Jan. 23, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Pentoxifylline Extended-Release (ER) Tablets, USP 400mg.
Key Points:
- BAUDETTE, Minn., Jan. 23, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Pentoxifylline Extended-Release (ER) Tablets, USP 400mg.
- ANI’s Pentoxifylline ER Tablets are the generic version of the Reference Listed Drug (RLD) Trental®.
- “We are pleased to continue the momentum in our generics business with another launch into a limited competition market.
- ANI remains committed to driving growth through superior new product launch execution, operational excellence, cost-competitiveness, and supply reliability.
Retrieved on:
Tuesday, January 16, 2024
CGT,
Patient,
OS,
ANI,
Health,
Food and Drug Administration,
USP,
RLD,
Food,
Indometacin,
FDA,
Abbreviated New Drug Application,
Pharmaceutical industry BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.
Key Points:
- BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.
- ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension.
- The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
- "With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.
Retrieved on:
Wednesday, November 22, 2023
Key Points:
- To schedule a 1x1 meeting with the Company, please contact [email protected] .
- The live and archived webcast will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations.
- The replay of the webcast will be accessible for 30 days.
Retrieved on:
Wednesday, November 8, 2023
Patient,
FDA,
Growth,
ANI,
Development,
Rare disease,
EBITDA,
Nephrology,
GAAP,
ACTH,
Anders,
USP,
Purified,
CGT,
Neurology,
Generic,
Rheumatology,
Bank,
Pharmaceutical industry,
Video game,
Generic drug,
IQVIA -- Generics, Established Brands and Other reported net sales of $102.1 million, representing year-over-year growth of 43.4% --
Key Points:
- Nikhil Lalwani, President and CEO of ANI stated, “Strong execution has resulted in another record quarter for revenue and adjusted non-GAAP EBITDA, positioning us to raise full year 2023 guidance for the third consecutive quarter.
- Third Quarter 2023 Financial Highlights:
Net revenues were $131.8 million compared to $83.8 million in Q3 2022.
- Since the launch of Cortrophin Gel, the overall ACTH category has experienced six consecutive quarters of year-over-year growth from second quarter 2022 to third quarter 2023.
- Sales of generic pharmaceuticals products, established brands and other grew 43.4% year-over-year in the third quarter of 2023.
BAUDETTE, Minn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will participate at two upcoming healthcare conferences as follows:
Key Points:
- BAUDETTE, Minn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will participate at two upcoming healthcare conferences as follows:
To schedule a 1x1 meeting with management, please contact [email protected] .
Retrieved on:
Wednesday, October 25, 2023
BAUDETTE, Minn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its third quarter 2023 financial results on Wednesday, November 8, 2023, prior to the market open.
Key Points:
- BAUDETTE, Minn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its third quarter 2023 financial results on Wednesday, November 8, 2023, prior to the market open.
- Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:
BAUDETTE, Minn., Oct. 02, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and commercial availability of a 1-mL vial (80 USP units/1 mL) of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel). The 1-mL vial is now available via Cortrophin Gel’s existing specialty pharmacy network and will also be available for ordering via national specialty distributors. Cortrophin Gel is already available in a 5-mL vial. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below.
Key Points:
- Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis.
- At that time, Cortrophin Gel became the first newly commercialized drug indicated for appropriate patients with acute gouty arthritis flares in 12 years.
- For some of these patients, Cortrophin Gel may be an appropriate additional treatment option for their flares.
- Cortrophin Gel is the only FDA-approved ACTH therapy indicated for the treatment of appropriate patients with acute gouty arthritis flares.
Retrieved on:
Monday, September 18, 2023
Key Points:
- To schedule a 1x1 meeting with the Company, please contact [email protected].
- The live and archived webcast will be accessible from the Company’s website at www.anipharmaceuticals.com , under the Investors section under Events and Presentations.
- The replay of the webcast will be accessible for 90 days.
Retrieved on:
Tuesday, September 12, 2023
Abbreviated New Drug Application,
ANI,
Food and Drug Administration,
Tablet,
RLD,
Estradiol,
Patient,
Estradiol valerate,
ANDA,
FDA,
Food,
Pharmaceutical industry,
IQVIA BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.
Key Points:
- BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.
- ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®.
- The According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Estradiol Tablets USP is approximately $40.9 million.
- “The approval and launch of Estradiol Tablets, so quickly following our launch last month of Estradiol Gel, exemplifies the ongoing strength of ANI’s Generics portfolio as well as our ongoing commitment in ensuring that patients and providers have access to the high-quality medications they depend on,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
