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 a study conducted by the Association of Accessible Medicines (formerly Generics Pharmaceutical Association), generic drugs save patients an estimated $3 billion a week. 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?
The majority of Amneal products are made in the U.S. and the remainder at the company’s India facilities. All Amneal products are manufactured in accordance with U.S. FDA regulations. Amneal has seven FDA-compliant, state-of-the-art, U.S. manufacturing facilities in New York, New Jersey and California, two sales operations and distribution facilities in Kentucky, one manufacturing facility in Ireland, and four manufacturing plants in India*.
*As of April 16, 2018
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.
Are Amneal products kosher?
Amneal makes no claims regarding the kosher status of its products. For kosher considerations, patients should consult their spiritual leader and physician for guidance.
How can I find out more about a specific product I am taking?
Amneal maintains an extensive product listing on our web site. The catalog features all the Amneal and Impax products currently being sold (as well as discontinued products still available in the marketplace). If you cannot find the answers you need from the product information or references, our Customer Response team is ready to assist. For information about an Amneal product, call toll-free, (866) 525-7270 or email email@example.com. For information about an Impax product, call (877) 994-6729, option 2 or email firstname.lastname@example.org.
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.
For Amneal products, contact us at (877) 835-5472, option 1 or at DrugSafety@www.amneal.com.
For Impax products, contact us at (877) 994-6729, option 2 or email@example.com. You may also reach us via the Adverse Event and Product Complaint form at: http://ae.impaxlabs.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.