Phytonadione

MUMBAI, India and NAPLES, Fla., Oct. 8, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe. The U.S. FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited and is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency. Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the U.S. (IQVIA MAT Aug 2026). About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy. To know more, visit or follow us on LinkedIn * Safe Harbor Statement SOURCE Lupin Pharmaceuticals, Inc. 21% more press release views with Request a Demo

Net revenues of $183.9 million for the three months ended June 30, 2026 GAAP net income of $30.3 million, or $0.67 per share, for the second quarter Adjusted non-GAAP net income of $40.8 million, or $0.91 per share, for the second quarter Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA, Calif., Aug. 6, 2026 /PRNewswire/ -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months ended June 30, 2026. "Our second quarter results reflect the continued execution of our long-term strategy to build a more diversified and innovative biopharmaceutical company. While we continued to navigate pricing and competitive dynamics across portions of our portfolio, we successfully achieved key goals including overall revenue growth, expansion of gross margins, meaningful launches of new products, and continued advancement from both our generic and proprietary development pipelines. These results demonstrate the strength of our integrated business model and position us well for long-term sustainable growth," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. Second Quarter Results Changes in net revenues as compared to the second quarter of the prior year were primarily driven by: BAQSIMI® sales decreased primarily due to a lower average selling price, as a result of a change in gross-to-net discounts due to changes in chargebacks and rebates and changes to the customer mix, impacting sales of approximately $8.1 million. This decrease was partially offset by an increase in unit volumes, contributing $6.9 million in sales driven by our continued marketing efforts. Achieved the first annual net sales milestone under the asset purchase agreement with Eli Lilly & Company, or Lilly, for BAQSIMI®, with sales of $175.0 million for the contract year. The milestone triggers a payment of $100.0 million to Lilly which is due in the third quarter of 2026. Primatene MIST® sales decreased due to the timing of customer purchases rather than changes in the underlying consumer demand. In store demand shows continued growth. Epinephrine sales slightly decreased primarily due to a decrease in our epinephrine multi-dose vial product, as a result of increased competition, impacting sales by $2.2 million. This decrease was partially offset by an increase in demand for our epinephrine pre-filled syringe, as a result of other supplier shortages, contributing $1.9 million in sales. Glucagon sales decreased primarily due to a lower average selling price, impacting sales by $7.5 million, as well as a decrease in unit volumes, which impacted sales by $1.2 million, as a result of competition and the continued shift to ready-to-use glucagon products such as BAQSIMI®. Ipratropium bromide sales were $8.4 million following a successful launch in April 2026. Other pharmaceutical product sales increased primarily due to recently launched products including an increase in iron sucrose sales of $3.5 million and teriparatide sales of $4.5 million, which we launched in August 2025 and December 2025, respectively. Albuterol sales increased primarily due to an increase in unit volumes, as we continue to see positive growth since its launch in August 2024. Additionally impacting sales, were an increase in phytonadione and sodium bicarbonate sales, driven by heightened demand, and an increase in API sales from our ANP subsidiary. Changes in the cost of revenues and gross margin were primarily driven by: Recently launched products, including iron sucrose, teriparatide and ipratropium bromide, as well as an increase in sales of phytonadione, all of which are higher-margin products. This was partially offset by: The impact of lower average selling price for BAQSIMI®, glucagon, and our epinephrine multi-dose vial product Increased manufacturing expenses due to the expansion of our manufacturing facility in Rancho Cucamonga, CA Selling, distribution, and marketing expense increased primarily due to increased freight expense and the increase in marketing efforts for BAQSIMI®. General and administrative expenses increased primarily due to an increase in legal expenses, expenses associated with implementing a new ERP system and salary and personnel-related expenses. Research and development expenses increased due to an increase in clinical trials expense, primarily for our insulin pipeline products, as well as an increase in salary and personnel-related expenses. This increase was partially offset by a decrease in material and supply expenses. The change in non-operating expenses, net, is primarily a result of foreign currency fluctuation, as well as the mark-to-market adjustments relating to our interest rate s during the three months ended June 30, 2026. Cash flow provided by operating activities for the six months ended June 30, 2026, was $99.2 million. Pipeline Information The Company currently has one abbreviated new drug application ("ANDA") and one biosimilar insulin candidate filed with the FDA for products targeting a combined market size exceeding $1.6 billion, along with two biosimilar products in development targeting a market size exceeding $3.5 billion, and three generic products in development targeting a market size of over $1.2 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2026, supplemented by data provided by the branded company for one of the generic targets. The Company is developing multiple proprietary products with injectable, topical and intranasal dosage forms. The Company's proprietary pipeline also includes four recently in-licensed products including three proprietary peptides targeting oncology and ophthalmology indications, and a fully synthetic corticotropin compound designed to address inflammatory and autoimmune conditions. Conference Call Information The Company will hold a conference call to discuss its financial results today, August 6, 2026, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which generally excludes amortization expense, share-based compensation, impairment charges, certain debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Market Data This press release contains market data that we obtained from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our industry sources are reliable, we do not independently verify the information. The market data may include projections that are based on a number of other projections. While we believe these assumptions to be reasonable and sound as of the date of this press release, actual results may differ from the projections. About Amphastar Pharmaceuticals, Inc. Amphastar is a biopharmaceutical company that focuses on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells active pharmaceutical ingredient, or API products. Most of the Company's finished products are contracted and distributed through group purchasing organizations, drug wholesalers, and drug retailers. More information and resources are available at . Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, BAQSIMI®, Primatene MIST®, REXTOVY®, Amphadase®, and Cortrosyn®, are the property of Amphastar. Forward-Looking Statements All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth and our ability to continue to scale, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the impact of our products, including their potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our long-term strategic vision, our ability to leverage our existing expertise and technology, the impacts of any licensing agreements and ability to commercialize additional therapies, our in-house manufacturing expertise, our ability to deliver high-quality, affordable therapies to patients, our commercial momentum and position in the market. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ("SEC"), including in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 26, 2026, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026, and our other filings or reports that we may file with the SEC. You can locate these reports through our website at and on the SEC's website at . The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. SOURCE Amphastar Pharmaceuticals, Inc. 21% more press release views with Request a Demo