Amneal Expands Broad Injectables Portfolio to Over 40 Products with the Addition of Six New Therapies

The Company’s leading R&D capabilities and robust, expanded manufacturing capacity are helping to address chronic market shortages

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the continued expansion of its injectables portfolio with six new injectable product launches during the second quarter of 2024, bringing the Company’s total number of commercial injectable products available for the U.S. institutional market to over 40.

The growth of Amneal’s broad injectables portfolio will help address shortages of critical products where there may be little or no clinical alternative, including in key categories such as oncology. The American Society of Health System Pharmacists (ASHP) currently lists 323 active U.S. drug shortages, with about half representing injectables.

Notably, three of Amneal’s six new injectable products are currently on the ASHP drug shortage list. With these new launches, Amneal now provides 13 injectables that are on the ASHP shortage list.

Amneal’s Q2 2024 injectable product launches:

 

Product launch

Dosage form

ASHP drug shortage

1

PEMRYDI RTU®

Vial

No

2

Atropine sulfate

Prefilled syringe

Yes

3

Docetaxel

Injection

Yes

4

Foscarnet

IV bag

No

5

Methylprednisolone acetate

Multi-dose vial

Yes

6

Calcium gluconate

Vial

No

“The persistent shortage of quality injectables is driven by multiple factors, including unstable market economics, supply chain disruptions and the need for supply redundancy. Amneal has made meaningful investments to expand our capacity and capabilities and deliver on our goal to be a significant injectables player. Importantly, we are building a robust portfolio of injectables that can serve as a reliable solution to market shortages. We are focused on being a partner our customers can count on to provide a consistent supply of high-quality medicines for their patients,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics.

Amneal has tripled its injectables capacity to 60 million units across four manufacturing facilities over the past few years and expects to have over 60 commercial injectable products in 2025. In particular, the Company is launching branded oncology 505(b)(2) products such as PEMRYDI RTU®. These injectables are new, ready-to-use presentations that can improve pharmacy efficiency by reducing clinician steps. Amneal expects to launch two to three new 505(b)(2) injectables per year going forward.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

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