Amphastar Pharmaceuticals Recognized By FDA For Addressing Critical Drug Shortages

$AMPH

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) has recently been honored with the Drug Shortage Assistance Award by the US Food and Drug Administration (FDA). This accolade was awarded to International Medication Systems, Ltd. (IMS), a subsidiary of Amphastar, for its proactive efforts in addressing the persistent shortage of epinephrine injection, 0.1 mg/mL syringes.

This initiative is part of a broader commitment by Amphastar and its subsidiaries to ensure the availability of essential medications, emphasizing the company’s dedication to public health and quality manufacturing. The FDA’s acknowledgment through this award highlights the importance of addressing drug supply challenges. In recent times, the FDA has collaborated with manufacturers to prevent numerous drug shortages, reflecting a significant impact on public health by ensuring timely and necessary care for patients.

Amphastar’s current pipeline includes four abbreviated new drug applications (ANDAs) targeting products with a combined market size exceeding $2 billion. Additionally, the company is developing four biosimilar products and two generic products aimed at markets totaling more than $8.3 billion. These developments are based on IQVIA data for the 12 months ending December 31, 2024.

Amphastar’s Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. . (ANP), is also making strides by developing multiple Drug Master Files (DMFs) with the FDA, further contributing to the company’s robust product pipeline. The company also markets insulin API products, with most of its finished products being used in hospital or urgent care clinical settings.By maintaining a focus on critical drug shortages and expanding its product pipeline, Amphastar is poised to meet the growing demands of the healthcare sector while ensuring patient care remains uninterrupted.

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