Learn About Generics

Making medicines more affordable for 30+ years

For more than 30 years, generics – including Amneal products – have helped make medicines more accessible and more affordable for millions of patients. And while more people than ever are choosing generic medicines when available, we think it’s important to review some key facts about generics in general and our generic products specifically.

Learn more by navigating the questions below.

What is a generic?

A generic drug’s active ingredients are chemically identical to and as effective as their branded counterparts and they are typically sold at significantly lower prices. According to the Association of Accessible Medicines 2023 U.S. Generic and Biosimilar Medicines Savings Report, these lower-cost drugs saved Americans more than $2.9 trillion in the last decade.

To obtain FDA approval a generic drug must:

Contain the same active ingredients as the brand drug (inactive ingredients may vary)
Be identical in strength, dosage form and route of administration
Have the same treatment indications
Be bio-equivalent
Meet the batch requirements for identity, strength, purity and quality
Be manufactured under the same strict standards of FDA‘s good manufacturing practice regulations required for innovator products

For more information, please visit the U.S. FDA Office of Generic Drugs website.

Where does Amneal make its generic products?

Amneal products are made in one of our three U.S. plants or in our India facilities. We hope to soon start shipping inhalation product from our Ireland site as well. All Amneal products are manufactured in accordance with U.S. FDA regulations.

How do I know Amneal generics will work?

To gain approval to manufacture and distribute a generic drug, manufacturers are required to develop formulas of the identical active ingredients used in the branded product and must demonstrate bioequivalence to the brand under strict U.S. FDA guidelines.

At Amneal, we have a team dedicated to ensuring bio-equivalence of all our generic products. We also take quality very seriously. Our quality management organization works seamlessly with our R&D teams to develop and manufacture our generic products. A comprehensive “quality-by-design” approach ensures quality throughout every phase of the product life cycle. Learn more about what goes into making high-quality Amneal medications.

How can I find out more about a specific product I am taking?

Amneal maintains an extensive product listing here on our web site. The catalog features all Amneal products currently being sold as well as recently discontinued products that may still be available in the marketplace.

What should I do if I have questions or concerns about a drug reaction or the effectiveness of a medication I’m taking?

If you are experiencing a serious event, please immediately call 9-1-1. If you are having an adverse reaction of any kind, or simply have a concern you would like to discuss, please do not hesitate to contact the Drug Safety team at (877) 835-5472, option 3 or email DrugSafety@amneal.com.

Amneal reviews any and all patient reports thoroughly.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call (800) FDA-1088.