Welcome to our dedicated page for Ani Pharmaceutic news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on Ani Pharmaceutic stock.
ANI Pharmaceuticals Inc. (ANIP) delivers innovative solutions in specialty generics and complex drug formulations, focusing on therapeutic areas with high barriers to entry. This page provides investors and healthcare professionals with timely updates on regulatory milestones, manufacturing developments, and strategic initiatives within controlled substances, oncology, and rare disease therapies.
Discover official press releases covering ANIP’s FDA submissions, product launches, and financial results alongside analysis of its Minnesota-based manufacturing capabilities. Our repository includes updates on niche segments like hormonal therapies and extended-release formulations, reflecting the company’s commitment to addressing unmet medical needs.
Bookmark this page for direct access to ANIP’s latest corporate announcements, partnership details, and therapeutic pipeline progress. Stay informed about developments in cGMP-compliant production and market expansions through verified, up-to-date reporting.
Cosette Pharmaceuticals has announced the acquisition of US marketing rights for Betaine Anhydrous for Oral Solution from ANI Pharmaceuticals (ANIP), beginning immediate shipping to customers. This product provides an important treatment option for patients suffering from homocystinuria, a rare genetic disorder. The CEO of Cosette,
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will announce its fourth quarter and full year 2022 financial results on March 9, 2023, before the market opens. The call will include insights from Nikhil Lalwani, CEO, and Stephen P. Carey, CFO, at 8:30 a.m. ET. Interested parties can participate via a conference call at 800-343-5172 or through a webcast available on the ANI website. Following the call, a replay will be accessible for two weeks. ANI Pharmaceuticals focuses on developing high-quality branded and generic pharmaceuticals, particularly in addressing high unmet medical needs.
ANI Pharmaceuticals (NASDAQ: ANIP) has received FDA approval for its Levocarnitine Tablets USP, 330 mg, a generic version of the branded drug Carnitor®. The U.S. market for Levocarnitine Tablets is valued at approximately $10 million annually. This launch aligns with ANI's mission to enhance patient access to affordable medicines and reinforces its commitment to limited-competition products. The company aims for sustainable growth through its generics and innovative product lines, leveraging its manufacturing capabilities.
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, 20 mg/5 mL, a generic version of Prozac®. This generic drug targets a U.S. market estimated at $14.6 million, according to IQVIA/IMS Health. CEO Nikhil Lalwani emphasized ongoing commitment to affordable generics, showcasing the company's focus on enhancing its generics business. The approval may potentially boost ANI's sales and market presence, reflecting its strategic growth in the pharmaceutical sector.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Abbreviated New Drug Application for Trimethoprim Tablets USP, 100 mg. This product is a generic version of the established Trimethoprim Tablets, targeting an annual U.S. market worth approximately $16.8 million according to IQVIA/IMS Health. CEO Nikhil Lalwani highlighted ANI's commitment to bringing niche products to market while expanding its generics portfolio.
ANI Pharmaceuticals reported third-quarter 2022 net revenues of $83.8 million, marking a 61% year-over-year growth. However, the net loss available to common shareholders stood at $(9.0 million), with a diluted GAAP loss per share of $(0.55). Adjusted non-GAAP EBITDA reached $19.6 million. The company reiterated its full-year 2022 guidance for net revenues between $295 million and $315 million. Key product Cortrophin generated $12.6 million in sales, with substantial gains in patient cases initiated and prescriber engagement.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its third quarter 2022 financial results on November 9, 2022, before market opening. The Company aims to discuss these results on a conference call at 8:00 a.m. ET. Interested parties can access the call via toll-free number 800-245-3047 or through a live webcast available on their website. A replay will be available shortly after the call. ANI focuses on developing, manufacturing, and marketing branded and generic pharmaceuticals to meet high medical needs.
ANI Pharmaceuticals, Inc. announced the appointment of Krista L. Davis as Chief Human Resources Officer, effective September 12. With over 20 years of executive leadership experience, including a significant role at Novartis, Davis aims to enhance organizational effectiveness during a crucial growth phase for the company. Nikhil Lalwani, President and CEO, emphasized her strategic contribution to priority people and organizational issues, aligning with ANI's goals to deliver life-changing therapeutics.
ANI Pharmaceuticals will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 12:30 PM ET. CEO Nikhil Lalwani and CFO Stephen Carey will represent the company during the event. A webcast of the presentation will be accessible on the company’s website in the Investors section. Additionally, ANI will hold 1x1 meetings on the same day, which can be requested through H.C. Wainwright. ANI Pharmaceuticals focuses on developing high-quality branded and generic pharmaceutical products.
ANI Pharmaceuticals announced the launch of Prochlorperazine Maleate Tablets USP in 5 mg and 10 mg dosages, a generic version of Compazine®. Developed with Biophore India Pharmaceuticals, this product addresses a U.S. market worth approximately $30 million. ANI aims to enhance patient access to high-quality generics, with CEO Nikhil Lalwani emphasizing the importance of limited competition products. The launch reflects ANI's strategy of providing affordable medication options, contributing to their sustainable growth.