Consumer Information

Generic substitution for brand name drugs allows for greater access to medicines worldwide.

According to the U.S. Food and Drug Administration, a generic drug is identical (defined as bio-equivalent) to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. To gain FDA approval a generic drug must:
  • Contain the same active ingredients as the innovator drug (inactive ingredients may vary)
  • Be identical in strength, dosage form and route of administration
  • Have the same use indications
  • Be bio-equivalent
  • Meet the same 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.
Generic drugs’ active ingredients are chemically identical to and equally as effective as their branded counterparts and they are typically sold 80 - 85% less. According to a study conducted by the Generics Pharmaceutical Association, generic drugs save consumers an estimated $3 billion a week. For more information, please visit the U.S. FDA Office of Generic Drugs website.

Approximately 70% of Amneal products are made in the United States and the remainder at the company’s India facilities. All Amneal products are manufactured in accordance with U.S. FDA regulations. Amneal has six FDA-compliant, state-of-the-art, U.S. manufacturing facilities in New York and New Jersey, a sales operations and distribution facility in Kentucky, and five manufacturing plants in India.

To assist consumers with food allergies, Amneal has provided helpful resources within its U.S. Product Catalog. Once you access the catalog, a list of Amneal products is displayed. Locate the product in question and click on the word, “Detail” to the right of the product image. Here you will find key information about the product (indications, storage temperature, known allergens, etc.) as well as links to additional references, which appear to the right, under the product image. Of these, the Label and Prescribing Information documents provide extensive facts about the medication including potential interactions and product ingredients.

All Amneal Biosciences injectable products currently available are latex free. If we market a product with latex, we will mention it as an exception and clearly indicate this on the product sheet and catalog detail page.

Amneal encourages all consumers to review this information for answers to the most common questions. If you cannot find the answers you need here or require additional details, the Customer Response team is ready to assist.  Simply call, toll-free, 877.835.5472 or email drugsafety@amneal.com.

Every year, Amneal receives requests for information regarding the contents of our products. The requests come from rabbis and include a spreadsheet or questionnaire for us to complete and return. The information we provide comes from our own formulation and process, as well as information obtained from our raw material manufacturers. A great deal of effort has gone into providing accurate information. Rabbis evaluate the information we provide and make a determination about whether our products are kosher and/or acceptable for Passover. They then publish that to a listing. Amneal makes no direct claims regarding the kosher status of certain products. For Passover or other kosher considerations, patients should consult their spiritual leader and physician for guidance on whether to take a particular medication

To gain approval to manufacture and distribute a generic drug, the manufacturer is required to develop formulas of the identical active ingredients used in the branded product and must demonstrate bioequivalence to the established brand under strict U.S. FDA guidelines. At Amneal, we have an extensive and dedicated team with the sole responsibility to ensure that bio-equivalence is achieved. To understand more fully how generics are developed, tested and approved, click here http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm.

With full knowledge that its products are made for human consumption, the Amneal team takes quality extremely seriously. Amneal’s quality management organization works seamlessly with its R&D team of more than 800 scientific experts to develop and produce its generics. A “quality-by-design” approach creates consistency throughout the development process, building quality into each step as well as every phase of the product life cycle. Click here to read about what goes into making high quality Amneal medications.

Amneal maintains an extensive product listing here at amneal.com. When you click on the Product Catalog you will be taken to a page featuring all the Amneal products currently being sold (as well as discontinued products still available in the marketplace). When you locate your product, click on the word “Detail” to the right of the product image. Here you will find key information about the product (indications, storage temperature, known allergens, etc.) as well as links to additional references to the right under the product image.

Of special interest to consumers are the Label and PI (Prescribing Information) PDF documents. These provide extensive facts about the medication such as product ingredients, dosage instructions, potential interactions, and safety precautions. We encourage all patients to review this important information to find answers to most questions. If you cannot find the answers you need from the product information or references, the Customer Response team is ready to assist. Simply call, toll-free, 866.525.7270 or email customerresponse@amneal.com.

Amneal takes pride in manufacturing high-quality generic prescription products at affordable prices. As its generics are already priced well below their brand equivalents, Amneal does not currently offer a patient assistance program.

In these challenging times, Amneal understands how paying even for lower cost generic medications can be a burden to many. For those with financial difficulties who are seeking assistance, Amneal recommends checking with the companies that market the branded version of the prescribed medication. Several brand manufacturers offer such programs. Alternatively, there are organizations that specialize in helping patients in need of assistance. For a list of these, simply type “patient assistance programs” or “patient assistance for prescriptions” into your Internet browser or search engine.

If you are experiencing a serious life-threatening event, please immediately call 9-1-1.

Amneal reviews any and all patient reports thoroughly. 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 via telephone at 877.835.5472, or at DrugSafety@amneal.com.

All reports are processed in full compliance with FDA requirements in order to ensure proper documentation and timely follow-up.

Additional information about reporting problems with medication, including a convenient and downloadable consumer guide is available on the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm.

In order to ensure you are getting real Amneal products, make sure to purchase your prescription medication from a licensed pharmacy—retail or mail-order.  These pharmacies closely follow the published “FDA Guidance on Standards Development for Prescription Drug Supply Chain.” Solid procedures and safety checks at these establishments leave little room for counterfeits to enter the supply stream.

Use caution when purchasing your medication outside the United States or from an on-line pharmacy that does not require a physician’s prescription.  Not licensed or monitored by the FDA, these “e-tailers” and non-US drug stores are how most counterfeit drugs enter the market.  There is no way to know how these establishments procured their product, where they were made or what ingredients are actually in the product.  If ingested, they can prove to be ineffective at best and extremely harmful—even deadly—at worst.

Any on-line pharmacy that sells prescription drugs without requiring either a written prescription or direct contact with the prescribing physician’s office is doing so in violation of the Food, Drug and Cosmetic Act and, thus, engaging in a criminal activity. Many of them manage this because they physically reside outside the U.S.—outside of FDA enforcement jurisdiction yet, their intent is undoubtedly criminal.  Do not trust criminals with your health.

There are pharmacies in border towns and tourist destinations in Mexico that are very professional in appearance, very clean, staffed with “pharmacists” wearing white lab coats, selling bottles of counterfeit medications.  These pharmacies exist for the sole purpose of taking advantage of tourists from the U.S. and Canada.

For tips on how to educate and protect yourself when purchasing medication outside the U.S. or over the internet, click on or copy and paste the following URL into your browser:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm.  The FDA website offers a wealth of information for consumers regarding counterfeit drugs and safe buying practices.

And to learn even more, visit http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm.

If you believe a person or company is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics, report it to FDA.

To report problems with FDA-regulated products, call your local FDA Consumer Complaint Coordinator.

To report unlawful sales of medical products on the Internet, visit Reporting Unlawful Sales on Internet.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Additionally, you can contact the medication’s authentic manufacturer and request that they validate they produced that specific product with that National Drug Code (NDC) and Lot (specific to a given production batch) numbers.  If not, you can report to them that the product is counterfeit.

Overall, caution is the recommended approach to purchasing prescription pharmaceutical products online and/or outside the United States.