Amphastar Pharma

Amphastar Pharmaceuticals, Inc. engages in developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, and insulin active pharmaceutical ingredient. It operates through Finished Pharmaceutical Products and Active Pharmaceutical Ingredients Products segments. The Finished Pharmaceutical Products segment manufactures, markets, and distributes Primatene Mist, enoxaparin, naloxone, phytonadione, lidocaine, and other critical and non-critical care drugs. The Active Pharmaceutical Ingredients Products segment offers RHI API and porcine insulin API for external customers and internal product development. The company was founded by Zi-Ping Luo and Yong Feng Zhang on February 29, 1996 and is headquartered in Rancho Cucamonga, CA.

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Amphastar Pharma excels in Q4 with strong revenue growth and product success

Amphastar Pharma's Q4 2022 performance reflects strong revenue growth, profitability, and product success, positioning the company well for future growth.
The company's focus on high-margin products, FDA approvals, and strategic investments in marketing and R&D underscore its commitment to innovation and market competitiveness.
While facing challenges in sustaining growth and managing costs, Amphastar Pharma has opportunities for expansion through product development, market penetration, and strategic initiatives.

Amphastar Pharma excels in Q1 2023, eyes growth opportunities

Amphastar Pharma's Q1 2023 showcased robust financial performance, driven by revenue growth and strategic product initiatives.
While facing challenges in market dynamics and margin management, the company is well-positioned to capitalize on growth opportunities.
With a focus on innovation, market expansion, and financial strength, Amphastar Pharma demonstrates resilience and potential for sustained success.

Amphastar Pharma excels in Q2 with revenue growth and innovation

Amphastar Pharma's Q2 2023 performance reflects strong revenue growth, improved profitability, and operational efficiency, underpinned by robust sales across key products.
While facing challenges such as FDA approval delays and pipeline setbacks, the company's strategic focus on proprietary products and innovation presents opportunities for sustained growth.
By capitalizing on market demand, enhancing margins, and advancing its product pipeline, Amphastar is poised to navigate challenges and capitalize on opportunities for long-term success.

Amphastar Pharma excels in Q3 with robust revenue growth

Amphastar Pharma delivered impressive financial results in Q3 2023, marked by significant revenue growth and profitability improvements.
While facing challenges in sustaining rapid sales growth and managing debt obligations, the company's strategic focus on product expansion and market presence presents growth opportunities.
Overall, Amphastar Pharma's strong performance, diverse product portfolio, and financial stability position it well for future growth and value creation for stakeholders.

Amphastar Pharma excels in Q4 2023, eyes growth opportunities

Amphastar Pharma's Q4 2023 performance reflects robust growth in revenues, profit, and net income, driven by strategic focus and product demand.
While facing challenges like lower gross margins and capacity expansions, the company is poised for growth through innovation and market opportunities.
Opportunities lie in R&D advancements, product launches, and financial strength, positioning Amphastar Pharma for continued success and expansion.

Amphastar Pharma excels in Q1 2024, eyes growth through innovation

Amphastar Pharma's Q1 2024 showcases strong financial performance and strategic focus on product innovation and market expansion. While facing challenges in pricing and regulatory landscape, the company is poised for growth through new product launches and market penetration strategies.

Amphastar Pharma reports revenue growth amidst margin challenges and regulatory hurdles

Amphastar Pharma's Q3 performance showed revenue growth driven by key products.
While facing challenges in net income and margins, the company aims for sustainable growth.
Opportunities lie in product launches, market expansion, and regulatory progress.
Overall, Amphastar Pharma navigates financial challenges with strategic initiatives.

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Reports Net Revenues of $83.4 Million for the Three Months Ended September 30, 2020 Reports Net Revenues of $83.4 Million for the Three Months Ended September 30, 2020

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2020

As of late, it has definitely been a great time to be an investor in Amphastar.

Amphastar's Shares March Higher, Can It Continue?

RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System. For the past 40 years, the Company has sold and marketed the product under the “grandfather” exception (now termed “unapproved”) to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the Company’s Atropine Sulfate injection for the year ended December 31, 2019 were $12.2 million. Amphastar’s CEO and President, Dr. Jack Zhang, commented: “The FDA’s approval of our Atropine Sulfate product, a product often on the Agency’s Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar’s manufacturing capacity to fulfill such market needs.” Pipeline Information The Company currently has four ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.5 billion, three biosimilar products in development targeting products with a market size of approximately $13.0 billion, and nine generic products in development targeting products with a market size of approximately $12.0 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2020. The Company is developing multiple proprietary pipeline products for injectable and intranasal dosage forms, including a new drug application for intranasal naloxone. Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMF, on file with the FDA and is developing several additional DMFs. Company Information Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products.  Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.  More information and resources are available at  www.amphastar.com . Amphastar’s logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, Primatene Mist®, Amphadase®, and Cortrosyn®, are the property of Amphastar. Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s 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. However, 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. You can locate these reports through the Company’s website at  http://ir.amphastar.com  and on the SEC’s website at  www.sec.gov .  Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar’s expectations to change. Noted products are trademarks or registered trademarks of their respective owners. Contact Information: Amphastar Pharmaceuticals, Inc.Bill PetersChief Financial Officer(909) 980-9484

Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection

RANCHO CUCAMONGA, Calif., Sept.  03, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that Bill Peters, CFO, Dan Dischner, Vice President of Corporate Communications and Human Resources, and Tony Marrs, Sr. Vice President Regulatory Affairs and Clinical Operations will participate in an Analyst-Moderated fireside chat at the Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020 at 3:20 p.m. Eastern Time.

Amphastar Pharmaceuticals to Present at the Wells Fargo 2020 Virtual Healthcare Conference

Amphastar Pharmaceuticals' (AMPH) Management on Q2 2020 Results - Earnings Call Transcript

On Thursday, August 06, Amphastar Pharmaceuticals (NASDAQ: AMPH) will release its latest earnings report.

Amphastar Pharmaceuticals's Earnings: A Preview

RANCHO CUCAMONGA, Calif., July  30, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the Company will release results for its second quarter of 2020 ended June 30, 2020, after the market closes on Thursday, August 6th, 2020, and will hold a conference call to discuss its financial results at 2:00 p.m. Pacific Time.

Amphastar Pharmaceuticals to Release Second Quarter Earnings and Hold Conference Call on August 6th, 2020

RANCHO CUCAMONGA, Calif., June  19, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that Bill Peters, CFO, Dan Dischner, Vice President of Corporate Communications and Human Resources, and Tony Marrs, Sr. Vice President Regulatory Affairs and Clinical Operations will be presenting at BMO Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020 at 1:00 p.m. Eastern Time.

Amphastar Pharmaceuticals to Present at the BMO Prescriptions for Success Healthcare Conference

RANCHO CUCAMONGA, Calif., June  12, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that Bill Peters, CFO, Dan Dischner, Vice President of Corporate Communications and Human Resources, and Tony Marrs, Sr. Vice President Regulatory Affairs and Clinical Operations will be presenting at the Raymond James Virtual 2020 Human Healthcare Innovation Conference on Thursday, June 18, 2020 at 11:40 a.m. Eastern Time.

Amphastar Pharmaceuticals to Present at the Raymond James Virtual 2020 Human Healthcare Innovation Conference

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RANCHO CUCAMONGA, Calif., June  09, 2020  (GLOBE NEWSWIRE) -- Amphastar® Pharmaceuticals, Inc., (NASDAQ: AMPH) (“Amphastar”), today announces that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial. Amphastar’s newly approved drug product was determined by the FDA to be therapeutically equivalent to Quelicin™ (Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial) distributed in the United States by Pfizer, Inc. Succinylcholine Chloride Injection is for intramuscular and intravenous use. It is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial

Amphastar Pharmaceuticals, Inc. (AMPH) Q1 2020 Results - Earnings Call Transcript

Amphastar (AMPH) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.

Why the Earnings Surprise Streak Could Continue for Amphastar (AMPH)

RANCHO CUCAMONGA, Calif., April  27, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) (“Amphastar”),  today announces that the U.S. Food and Drug Administration (“FDA”) has granted approval of its Abbreviated New Drug Application (“ANDA”) for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial. Amphastar’s newly approved drug product was determined by the FDA to be therapeutically equivalent to Adrenalin® (Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial) distributed in the United States by Par Pharmaceutical, Inc. Epinephrine Injection Multiple Dose Vial is for intramuscular, subcutaneous, and intravenous use, and is indicated for emergency treatment of allergic reactions (Type 1), including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial

RANCHO CUCAMONGA, Calif., April  13, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”), a California-based, specialty, generic pharmaceutical company, today announces a recent simplification of the Company’s management by removing a layer of management in the organizational structure.

Amphastar Pharmaceuticals, Inc. Announces Simplification of Management Structure

Amphastar Pharmaceuticals, Inc. (AMPH) Q4 2019 Results - Earnings Call Transcript

Amphastar (AMPH) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Analysts Estimate Amphastar Pharmaceuticals (AMPH) to Report a Decline in Earnings: What to Look Out for

RANCHO CUCAMONGA, Calif., Feb.  27, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (“FDA”) granted approval of its supplemental Abbreviated New Drug Application for Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50mL (1mEq/mL) Single-Dose Prefilled Syringe. This supplement is for manufacturing the product in the Company’s new manufacturing line at its International Medication Systems facility.

Amphastar Pharmaceuticals Receives FDA Approval for Supplement to its Abbreviated New Drug Application for Sodium Bicarbonate Injection, USP 8.4%, 50mEq/50mL

RANCHO CUCAMONGA, Calif., Jan.  28, 2020  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that on January 24, 2020, the U.S. Food and Drug Administration (“FDA”) issued a “MINOR” Complete Response Letter (“CRL”) for its Abbreviated New Drug Application (“ANDA”) for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose.   Amphastar responded to the MINOR CRL on January 27, 2020, and expects a decision from the FDA within three months.

Amphastar Announces the Receipt of a MINOR CRL for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial

Amphastar Pharmaceuticals, Inc. (AMPH) Management on Q3 2019 Results - Earnings Call Transcript

RANCHO CUCAMONGA, Calif., Aug.  29, 2019  (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that Jason Shandell, President, and Bill Peters, CFO, will be presenting at the Wells Fargo 2019 Healthcare Conference on Thursday, September 5, 2019 at 3:05 p.m. Eastern Time, Boston, MA.

Amphastar Pharmaceuticals to Present at the Wells Fargo 2019 Healthcare Conference

Amphastar Pharmaceuticals, Inc. (AMPH) Q2 2019 Results - Earnings Call Transcript

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Amphastar (AMPH) delivered earnings and revenue surprises of 233.33% and 6.36%, respectively, for the quarter ended March 2019. Do the numbers hold clues to what lies ahead for the stock?

Amphastar Pharmaceuticals (AMPH) Q1 Earnings and Revenues Surpass Estimates

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