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Amneal expands injectables portfolio with 6 new therapies

With these new launches, Amneal now provides 13 injectables that are on the ASHP shortage list.
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Amneal is expanding 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.

Amneal noted that the growth of its 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 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.

[Related: Amneal touts 39 retail, injectable product launches in 2023]

“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, Amneal 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.

[Read more: Amneal touts 26 generic new product launches in 2022]

Amneal’s Q2 2024 injectable product launches:

 Product launchDosage formASHP drug shortage

1

PEMRYDI RTUVialNo

2

Atropine sulfatePrefilled syringeYes

3

DocetaxelInjectionYes

4

FoscarnetIV bagNo

5

Methylprednisolone acetateMulti-dose vialYes

6

Calcium gluconateVialNo
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