International Medication Systems, Ltd. Receives FDA's Drug Shortage Assistance Award
Amphastar Pharmaceuticals (NASDAQ:AMPH) subsidiary International Medication Systems (IMS) has received the FDA's Drug Shortage Assistance Award for addressing the shortage of epinephrine injection 0.1 mg/mL syringes. The recognition highlights IMS's efforts in submitting and obtaining approval of a new drug application for epinephrine injection.
The company's pipeline includes 4 ANDAs targeting products with >$2 billion market size, 4 biosimilar products targeting >$7 billion market size, and 2 generic products targeting >$1.3 billion market size, based on IQVIA data for 2024. Amphastar is developing multiple proprietary products with injectable and intranasal dosage forms.
Amphastar Pharmaceuticals (NASDAQ:AMPH) ha ricevuto il premio FDA per l'assistenza nella carenza di farmaci tramite la sua controllata International Medication Systems (IMS) per aver affrontato la carenza di siringhe per iniezione di epinefrina 0,1 mg/mL. Questo riconoscimento evidenzia gli sforzi di IMS nel presentare e ottenere l'approvazione di una nuova domanda di farmaco per l'iniezione di epinefrina.
Il portafoglio dell'azienda include 4 ANDA che mirano a prodotti con una dimensione di mercato superiore ai 2 miliardi di dollari, 4 prodotti biosimilari con un mercato superiore ai 7 miliardi di dollari e 2 prodotti generici con un mercato superiore a 1,3 miliardi di dollari, basato sui dati IQVIA per il 2024. Amphastar sta sviluppando diversi prodotti proprietari con forme di dosaggio iniettabili e intranasali.
Amphastar Pharmaceuticals (NASDAQ:AMPH) ha recibido el Premio de Asistencia para la Escasez de Medicamentos de la FDA a través de su subsidiaria International Medication Systems (IMS) por abordar la escasez de jeringas de inyección de epinefrina 0.1 mg/mL. Este reconocimiento destaca los esfuerzos de IMS en presentar y obtener la aprobación de una nueva solicitud de medicamento para la inyección de epinefrina.
El pipeline de la empresa incluye 4 ANDA que apuntan a productos con un tamaño de mercado superior a 2 mil millones de dólares, 4 productos biosimilares que apuntan a un mercado superior a 7 mil millones de dólares, y 2 productos genéricos que apuntan a un mercado superior a 1.3 mil millones de dólares, basado en datos de IQVIA para 2024. Amphastar está desarrollando múltiples productos propios con formas de dosificación inyectables e intranasales.
Amphastar Pharmaceuticals (NASDAQ:AMPH)의 자회사 International Medication Systems (IMS)는 에피네프린 주사 0.1 mg/mL 주사기의 부족 문제를 해결한 공로로 FDA의 약물 부족 지원 상을 수상했습니다. 이 인정은 에피네프린 주사에 대한 새로운 약물 신청서를 제출하고 승인받기 위한 IMS의 노력을 강조합니다.
회사의 파이프라인에는 4개의 ANDA가 포함되어 있으며, 이는 20억 달러 이상의 시장 규모를 목표로 하고, 4개의 바이오시밀러 제품은 70억 달러 이상의 시장 규모를 목표로 하며, 2개의 일반 제품은 13억 달러 이상의 시장 규모를 목표로 하고 있습니다. 이는 2024년 IQVIA 데이터를 기반으로 합니다. Amphastar는 주사형 및 비강 투여 형태의 여러 독점 제품을 개발하고 있습니다.
Amphastar Pharmaceuticals (NASDAQ:AMPH) a reçu le Prix d'Assistance à la Pénurie de Médicaments de la FDA par l'intermédiaire de sa filiale International Medication Systems (IMS) pour avoir abordé la pénurie de seringues d'injection d'épinéphrine 0,1 mg/mL. Cette reconnaissance met en lumière les efforts d'IMS pour soumettre et obtenir l'approbation d'une nouvelle demande de médicament pour l'injection d'épinéphrine.
Le pipeline de l'entreprise comprend 4 ANDA visant des produits avec une taille de marché supérieure à 2 milliards de dollars, 4 produits biosimilaires visant un marché supérieur à 7 milliards de dollars, et 2 produits génériques visant un marché supérieur à 1,3 milliard de dollars, selon les données d'IQVIA pour 2024. Amphastar développe plusieurs produits propriétaires avec des formes posologiques injectables et intranasales.
Amphastar Pharmaceuticals (NASDAQ:AMPH) Tochtergesellschaft International Medication Systems (IMS) hat den FDA-Preis für Unterstützung bei Arzneimittelengpässen erhalten, weil sie das Problem des Mangels an Epinephrin-Injektionsspritzen mit 0,1 mg/mL angegangen ist. Diese Auszeichnung hebt die Bemühungen von IMS hervor, einen Antrag auf Zulassung eines neuen Arzneimittels für die Epinephrin-Injektion einzureichen und genehmigt zu bekommen.
Die Pipeline des Unternehmens umfasst 4 ANDAs, die Produkte mit einem Marktvolumen von über 2 Milliarden Dollar anvisieren, 4 biosimilar Produkte, die einen Markt von über 7 Milliarden Dollar anvisieren, und 2 Generika, die einen Markt von über 1,3 Milliarden Dollar anvisieren, basierend auf IQVIA-Daten für 2024. Amphastar entwickelt mehrere proprietäre Produkte mit injizierbaren und intranasalen Darreichungsformen.
- FDA recognition for addressing critical drug shortage
- Strong pipeline targeting >$10.3B market opportunity
- Multiple products in development across various dosage forms
- None.
Insights
Amphastar's FDA Drug Shortage Assistance Award represents significant strategic value beyond typical industry recognition. This award specifically acknowledges their subsidiary's successful resolution of a long-standing epinephrine injection shortage through NDA approval - demonstrating capabilities that competitors evidently couldn't match.
This recognition creates a compelling competitive advantage in the hospital and urgent care channels where Amphastar primarily distributes. Healthcare facilities prioritize reliable suppliers for critical emergency medications like epinephrine, potentially strengthening Amphastar's contracting position and pricing leverage in these institutional settings.
The pipeline details reveal multiple growth vectors across diverse market segments. With four ANDAs targeting a
The vertical integration through their Chinese subsidiary enhances supply chain control and cost structure advantages - particularly relevant given current industry-wide manufacturing challenges. This recognition validates Amphastar's manufacturing excellence and regulatory relationship at a time when reliable pharmaceutical production capabilities carry premium value.
The FDA Drug Shortage Assistance Award to Amphastar's subsidiary represents exceptional regulatory recognition that has material implications beyond superficial accolades. The FDA explicitly states they prevented 236 drug shortages in 2023, highlighting how selective this acknowledgment is and the agency's prioritization of supply reliability.
This recognition signals Amphastar's strong relationship with regulators - a critical intangible asset in pharmaceuticals. Companies with demonstrated track records of addressing drug shortages typically receive expedited reviews and enhanced communication channels with the FDA, potentially accelerating future approvals across their pipeline.
The successful epinephrine injection NDA approval demonstrates Amphastar's regulatory navigation capabilities for essential medications designated as shortage products. The FDA maintains heightened scrutiny on manufacturing quality for emergency medications, making this approval particularly meaningful as validation of Amphastar's quality systems.
Their numerous Drug Master Files through the Chinese subsidiary indicate sophisticated API control and vertical integration that meets FDA standards. This regulatory foundation creates pathways for accelerated approvals, as the critical chemistry and manufacturing controls documentation already has regulatory acceptance.
This recognition effectively positions Amphastar as a trusted manufacturing partner for addressing future critical drug shortages - a valuable position as the FDA increasingly focuses on supply chain resilience.
Recognized for contributions to address shortage of epinephrine injection, 0.1 mg/mL syringes
RANCHO CUCAMONGA, CA / ACCESS Newswire / March 28, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that International Medication Systems, Ltd. ("IMS"), a subsidiary of Amphastar Pharmaceuticals, Inc. ("Amphastar") received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration ("FDA"). This prestigious award recognizes IMS significant efforts in preventing and alleviating critical drug shortages, ensuring that patients have access to essential medications.
IMS is being recognized for its efforts to mitigate and resolve the long-standing drug shortage of epinephrine injection, 0.1 mg/mL syringes, including submitting and obtaining approval of a new drug application for epinephrine injection.
The FDA Drug Shortage Assistance Award honors companies that show a strong commitment to public health and quality manufacturing by taking proactive measures to address drug supply challenges.
"We are deeply honored to receive this recognition from the FDA," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "Our team is dedicated to ensuring a reliable supply of critical medications, and this award validates our ongoing efforts to prioritize patient needs. We understand the importance of consistent access to medicine, and we will continue to work diligently to prevent shortages."
Drug shortages pose a substantial public health threat, delaying and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent 145 drug shortages in CY 2017, 160 shortages in CY 2018, 154 in CY 2019, 199 in CY 2020, and 317 in CY 2021, 222 in CY 2022, and 236 in CY 2023.
Amphastar and its subsidiaries are committed to working closely with the FDA and other stakeholders to tackle drug supply issues and ensure that essential medications are available to patients across the country.
Pipeline Information
The Company currently has four abbreviated new drug applications ("ANDAs") on file with the FDA targeting products with a market size exceeding
Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs"), on file with the FDA and is developing several additional DMFs.
Company Information
Amphastar is a bio-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®, BAQSIMI®, Primatene MIST®, REXTOVYTM, 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, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the benefits BAQSIMI®, including its potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our ability to leverage our existing expertise and technology, and other future events. 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, including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025 and our other filings or reports that we may file with the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI®. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. 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.
Contact Information:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 476-3416
SOURCE: Amphastar Pharmaceuticals, Inc.
View the original press release on ACCESS Newswire
FAQ
What achievement did Amphastar's subsidiary IMS receive from the FDA in March 2025?
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