Amphastar Pharmaceuticals Inc - Company Profile

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Amphastar Pharmaceuticals Inc: Segment Analysis

Business Description

Amphastar Pharmaceuticals Inc (Amphastar), develops, discovers, manufactures and markets generic and proprietary pharmaceutical drug delivery systems. The company develops more than 20 commercial products and over 20 product candidates at different stages.

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R&D Overview

Amphastar conducts research and development (R&D) activities of the company focuses on the area of toxicity studies, analytical, pharmaceutical formulation, process development, synthetic and physical chemistry, drug delivery, device development, equipment and engineering, and clinical research statistical analysis. The company presently developing a portfolio of generic abbreviated new drug applications, proprietary product candidates, and biosimilar product candidates. As of December 31, 2022, the company had over 249 employees for research and development. In FY2022, Amphastar incurred R&D expenses of US$74.8 million which as a percentage of its revenue stood at 14.9%, and grew 29.6% YoY.

Business Segments

Overview

Includes the operations of Merck Sharpe & Dohme's, Merck's API manufacturing business in Eragny-sur-Epte, France. Manufactures two API products, porcine insulin API and recombinant human insulin API (RHI API).

Performance

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Overview

The segment’s manufactures and sells over 20 products. Provides products such as enoxaparin sodium injection, Cortrosyn, Amphadase, lidocaine jelly, Primatene mist, Naloxone, Phytonadione, Isoproterenol Hydrochloride, Medroxyprogesterone, Epinephrine and other critical and non-critical care drugs. Enoxaparin sodium injection is a generic version of Sanofi’s Lovenox, indicated for the prophylaxis of deep vein thrombosis and for the treatment of acute deep vein thrombosis. Enoxaparin is available in prefilled syringes with UltraSafe Needle Guard in seven different dosage forms. -Cortrosyn is a lyophilized powder used as a diagnostic agent in the screening of patients with adrenocortocal insufficiency. Primatene Mist is an over-the-counter epinephrine inhalation product candidate intended to be used for the temporary relief of mild asthma symptoms. Amphadase is a bovine-sourced hyaluronidase injection developed for subcutaneous fluid administration and subcutaneous urography. Amphadase improves the absorption and dispersion of radiopaque agents and other injected drugs. Lidocaine HCl jelly is a preservative-free topical local anesthetic used for urological procedures and also for variety of procedures. It is available in Uro-Jet prefilled syringe, designed to reduce discomfort during the product application. Lidocaine HCl, 4% topical solution is offered in the Laryng-O-Jet prefilled syringe. Naloxone HCl injection is indicated for the partial or complete reversal of narcotic depression. It is also used for the diagnosis of suspected acute opioid overdose. Naloxone HCl injection is available in two types of prefilled syringes, needleless Luer Jet prefilled syringe and Min-I-Jet prefilled syringe. Phytonadione injection is a Vitamin K that is used for newborn babies. Medroxyprogesterone injection is for the prevention of pregnancy. Manufactures a wide range of dosage formulations under other products category. These include critical care drugs, such as dextrose, epinephrine, morphine, atropine, calcium chloride, lidocaine and sodium bicarbonate; Lorazepam injection, sedative used prior to surgery and medical procedures; Ketorolac for acute pain management; and procainamide for ventricular arrhythmias.

Performance

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Geographical Segments

Performance

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Performance

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Performance

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