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Amphastar Pharma - AMPH STOCK NEWS

Welcome to our dedicated page for Amphastar Pharma news (Ticker: AMPH), a resource for investors and traders seeking the latest updates and insights on Amphastar Pharma stock.

Overview

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) is a specialty bio-pharmaceutical company renowned for its expertise in developing, manufacturing, marketing, and selling technically challenging injectable, inhalation, and intranasal pharmaceutical products. With operations centered in the United States and an established international presence, Amphastar has built a reputation for leveraging state-of-the-art, cGMP compliant facilities to meet high industry standards and regulatory requirements.

Operational Excellence

Operating multiple cutting-edge manufacturing facilities across the United States, China, and Europe, Amphastar demonstrates a robust global operational strategy. The company’s facilities adhere strictly to current Good Manufacturing Practices (cGMP), ensuring that every product meets the rigorous quality benchmarks mandated in the pharmaceutical industry. This commitment to operational excellence is further emphasized by its integrated research centers dedicated to the development of both generic and proprietary products.

Product Portfolio and Innovation

Amphastar’s diverse portfolio includes a wide range of products, from injectable drugs to inhalation and intranasal therapies, as well as insulin Active Pharmaceutical Ingredient (API) products. The company’s expertise in formulating complex drug products is reflected in its ability to manufacture products that are used primarily in hospital and urgent care clinical settings. Its portfolio is designed to target high-technical barrier market opportunities, ensuring that the products address critical therapeutic needs while satisfying strict regulatory standards.

Manufacturing and Quality Commitment

At the heart of Amphastar’s operations is a commitment to quality and innovation. The company’s facilities are equipped with advanced technology to support precise and efficient manufacturing processes. By maintaining cGMP compliance across its manufacturing sites, Amphastar is able to consistently deliver products that meet both domestic and international quality standards. This operational discipline underpins the company’s ability to secure substantial market share upon product launch.

Market Position and Distribution

Amphastar is strategically positioned within the pharmaceutical market through longstanding relationships with group purchasing organizations and drug wholesalers. This network not only enhances distribution capabilities but also solidifies the company’s market presence, particularly within the U.S. healthcare system. The systematic distribution through these channels ensures that its innovative products reach clinical settings where they are needed most.

Research and Development

The company’s dedicated research and development efforts are driven by a focus on both generic and proprietary products. Amphastar continually invests in R&D to refine its product formulations and expand its product pipeline. By filing abbreviated new drug applications (ANDAs) and developing biosimilars alongside proprietary drugs formulated in injectable and intranasal dosage forms, the company blends innovation with market demand. This adaptive approach reflects its ability to meet evolving therapeutic needs while maintaining regulatory compliance.

Industry Expertise and Strategic Approach

Amphastar’s deep-rooted expertise in pharmaceutical manufacturing is evident through its reliable production processes, adherence to quality standards, and commitment to continuous improvement. The company leverages its technical expertise and advanced manufacturing infrastructure to navigate a highly competitive environment. Its focus on technically challenging products positions it in a unique niche within the broader pharmaceutical industry, where every innovation is underpinned by robust scientific research and quality control.

Investor Focus and Competitive Landscape

For investors, analyzing Amphastar means understanding a company that skillfully balances high-quality manufacturing with strategic market positioning. The company's integrated approach to production and distribution, combined with its expertise in complex pharmaceutical formulations, provides a framework for evaluating its competitive standing. By focusing on well-established market channels and continuously evolving its product portfolio, Amphastar demonstrates a disciplined operational model that is built on quality assurance and technical proficiency.

Conclusion

This comprehensive overview of Amphastar Pharmaceuticals presents an in-depth examination of its operations and strategic positioning. The company’s commitment to quality, innovation, and regulatory compliance forms the backbone of its competitive edge. With advanced manufacturing facilities and a diverse product array, Amphastar continues to serve critical needs within the healthcare industry, offering insights for analysts and investors seeking a detailed understanding of its business model.

Rhea-AI Summary

Amphastar Pharmaceuticals reported net revenues of $103.0 million for Q1 2021, a 22% increase from Q1 2020. GAAP net income was $5.0 million, or $0.10 per share. Adjusted non-GAAP net income reached $13.6 million, or $0.27 per share. Key growth drivers included the launch of glucagon, along with strong sales of Primatene Mist® and epinephrine products. Operating cash flow was $22.8 million, reflecting robust business activity. The company is expanding its product pipeline, with five ANDAs and several proprietary products in development.

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Amphastar Pharmaceuticals (NASDAQ: AMPH) announced FDA approval for its Morphine Sulfate injection 1mg/mL in a 30mL Pump-Jet Prefilled Syringe System. The product is intended for severe pain management via Patient-Controlled Analgesia (PCA). In 2020, Morphine injection generated net revenues of $2.3 million. The company has five ANDAs, three biosimilars, and seven generics in development, with combined market potentials of $2.4 billion, $13 billion, and $10 billion respectively. Amphastar also operates with 17 Drug Master Files in the FDA, focusing on complex pharmaceutical products.

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Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will announce its first quarter 2021 financial results on May 6, 2021, after market close. A conference call to discuss these results is scheduled for 2:00 p.m. Pacific Time. The company specializes in developing and selling complex generic and proprietary pharmaceutical products, primarily for hospital and urgent care settings. Interested parties can access the call by dialing in or via the company's website.

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Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in an Analyst-Moderated fireside chat at the Needham Virtual Healthcare Conference on April 13, 2021, at 3:45 PM ET. Key executives, including CFO Bill Peters and VP of Corporate Communications Dan Dischner, will speak during the session. The presentation will be available via webcast on the company's website for 90 days post-event. Amphastar specializes in developing and marketing technically-challenging generic and proprietary injectable and inhalation products, primarily for hospital settings.

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Amphastar Pharmaceuticals (NASDAQ: AMPH) announced FDA approval for its Dextrose injection 50% in a 50 mL prefilled syringe. Previously marketed under the 'grandfather' clause, the product generated net revenues of $7.6 million in 2020. This approval allows Amphastar to address drug shortages, enhancing its manufacturing reputation. The company has several ANDAs and biosimilars in progress, targeting a cumulative market size of approximately $25 billion. CEO Dr. Jack Zhang emphasized the commitment to product quality and market needs.

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Amphastar Pharmaceuticals reported net revenues of $95.9 million for Q4 2020, up 15% year-over-year. Despite a GAAP net loss of $6.3 million or $0.13 per share, the company posted adjusted non-GAAP net income of $8 million, translating to $0.16 per share. For the full year, revenues reached $349.8 million, a 9% increase, with a GAAP net income of $1.4 million. Growth was driven by Primatene Mist® and epinephrine sales following recent product approvals. The firm remains optimistic for 2021, buoyed by a strong pipeline and recent FDA approvals.

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Amphastar Pharmaceuticals (NASDAQ: AMPH) will announce its fourth quarter 2020 financial results on March 15, 2021, after market close. A conference call is scheduled for 2:00 PM PT to discuss the results. Amphastar specializes in developing and selling generic and proprietary injectable and inhalation products used primarily in hospital settings. The announcement includes forward-looking statements regarding financial performance, market growth, and the potential impacts of COVID-19 on operations.

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Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in the Analyst-Moderated fireside chat at the Raymond James 2021 Institutional Healthcare Conference on March 2, 2021, at 1:20 PM Eastern Time. The event features key executives, including CFO Bill Peters and Sr. VP Tony Marrs. A webcast of the presentation will be available on the company's website for 90 days post-event. Amphastar specializes in developing and selling generic and proprietary injectable products, primarily for hospital settings. Further details about the company can be found on their website.

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Amphastar Pharmaceuticals (NASDAQ: AMPH) received FDA approval for its Glucagon for Injection Emergency Kit, 1 mg, marking the first FDA approval of a generic version of rDNA Glucagon. This product is indicated for severe hypoglycemia treatment and is bioequivalent to Eli Lilly's product. U.S. sales for Eli Lilly’s Glucagon Emergency Kit were approximately $144 million. Amphastar plans to launch the product within two months. The company has multiple ANDAs filed, targeting a market size of about $1.4 billion, with additional biosimilars and generics in development.

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Amphastar Pharmaceuticals reported net revenues of $83.4 million for Q3 2020, a 4% increase year-over-year. GAAP net income rose to $3.9 million, or $0.08 per share, while adjusted non-GAAP net income reached $7.6 million, or $0.15 per share. Key contributors to revenue growth included strong sales from Primatene Mist® and the successful re-launch of the epinephrine vial. The company remains focused on product development with five ANDAs targeting $1.5 billion market and three biosimilars targeting $13 billion in the pipeline.

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FAQ

What is the current stock price of Amphastar Pharma (AMPH)?

The current stock price of Amphastar Pharma (AMPH) is $28.29 as of April 1, 2025.

What is the market cap of Amphastar Pharma (AMPH)?

The market cap of Amphastar Pharma (AMPH) is approximately 1.4B.

What is Amphastar Pharmaceuticals' core business?

Amphastar specializes in developing, manufacturing, marketing, and selling technically challenging generic and proprietary pharmaceutical products, including injectable, inhalation, and intranasal formulations.

What types of products does Amphastar produce?

The company produces a range of products such as injectable drugs, inhalation and intranasal therapies, and insulin Active Pharmaceutical Ingredient (API) products, primarily used in clinical settings.

How do Amphastar's manufacturing facilities support its operations?

Amphastar operates multiple state-of-the-art, cGMP compliant facilities across the United States, China, and Europe, ensuring high-quality production and adherence to strict regulatory standards.

What role does research and development play at Amphastar?

R&D is central to Amphastar's operations. The company continually invests in developing both generic and proprietary products, enhancing its product pipeline and addressing high technical barriers in the pharmaceuticals market.

How does Amphastar distribute its products?

The company utilizes established relationships with group purchasing organizations and drug wholesalers to efficiently distribute its products, primarily across hospital and urgent care settings.

What distinguishes Amphastar in the competitive pharmaceutical landscape?

Amphastar stands out due to its integrated approach combining advanced manufacturing, rigorous quality control, and a diversified product portfolio tailored to meet high-demand therapeutic needs.

Can you explain the significance of cGMP compliance for Amphastar?

cGMP compliance ensures that Amphastar’s manufacturing processes meet the highest quality and safety standards, supporting reliable product performance and regulatory approval both domestically and internationally.

How does Amphastar manage regulatory challenges?

Amphastar maintains strict adherence to regulatory guidelines through state-of-the-art facilities and a dedicated R&D focus, ensuring all products are manufactured according to current Good Manufacturing Practices and relevant international standards.
Amphastar Pharma

Nasdaq:AMPH

AMPH Rankings

AMPH Stock Data

1.35B
36.73M
22.56%
76.09%
8.66%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
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United States
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