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877.835.5472 or DrugSafety@amneal.com

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A Consumer's Guide to Generic Drugs

What Does THAT Mean?

Consumer Information

At Amneal Pharmaceuticals, we care about both the products we make and the people who use them. We've created this page to help answer some common questions and to help you, our ultimate customer, get to know us as a trusted partner in your healthcare. We'll guide you through the resources available on our website for additional information and the answers you seek.

Who is Amneal Pharmaceuticals?

Known as "Generic's New Generation", Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic drugs. Amneal's zeal for quality and exemplary customer service have made it a rising star in the generic pharmaceutical marketplace. The company achieved a prescription growth rate of 114% from 2008 to 2009—the highest in the generic pharmaceutical industry according to IMS Health market data (June 2009). Since its founding in 2002, the firm has grown from high potential startup to the 10th largest supplier of generic prescription medications to the U.S. market. Amneal has progressed from its early beginnings producing Over-the-Counter, private label, oral solid pills to manufacturing and distributing a diverse, sophisticated array of prescription pharmaceutical products that serve a wide range of therapeutic categories in multiple dosage forms. Amneal Pharmaceuticals is headquartered in Hauppauge, New York and employs approximately 600 highly-qualified, seasoned professionals throughout its organization.

Why haven't I heard of Amneal?

Amneal sells its products to pharmacies rather than directly to the consumer. These pharmacies, in turn, put just the right quantity of medicine in each patient's prescription vial, limiting the visibility of our logo and label to consumers. Because of this, most consumers aren’t aware of the Amneal name. With a reputation for making the finest quality medications for almost a decade, Amneal is staffed with experts who joined us with years of experience at many of the largest U.S. pharmaceutical manufacturers—branded and generic. So, though Amneal may be new to many, the company is mature with expertise.

Where does Amneal make its products?

Almost all Amneal generic pharmaceuticals are made in the United States. Though just a few will soon be made in our FDA-certified international plant, each and every product is manufactured under the strictly regulated requirements of the U.S. FDA.

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 life-threatening event, please call 911 immediately.

Amneal takes patient reports very seriously. Whether you are having an adverse reaction or are concerned that an Amneal product is not effective, please contact our Drug Safety team at 877.835.5472 or drugsafety@amneal.com. Our process for addressing these incidents is fully compliant with all FDA requirements to ensure proper documentation and timely follow-up.

I have food allergies. Where can I learn whether a specific product I'm taking contains allergens?

To help consumers with food allergies, we’ve provided helpful resources within our Product Catalog. Once you access the Product Catalog (by clicking on the link in the left navigation list on this page) 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.). Links to additional references 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.

We encourage all patients to review this information for answers to the most common questions. If you cannot find the answers you need here or require additional details, our Customer Response team is ready to assist. Simply call us toll-free at 877.835.5472 or email customerresponse@amneal.com.

How do I know Amneal generics will work?

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 sole responsibility to ensure that bio-equivalence is achieved. To understand more fully how generics are developed, tested and approved, click here.

With full knowledge that its products are for human consumption, the Amneal team takes quality extremely seriously. Amneal's Quality Management organization works seamlessly with its prolific R&D team of more than 70 U.S.-based 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.

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

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, our Customer Response team is ready to assist. Simply call us toll-free at 877.835.5472 or email customerresponse@amneal.com.

Does Amneal have a patient assistance program to help people pay for their medication?

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

In these challenging times, we understand how paying even for lower cost generic medications can be a burden to many. For those with financial difficulties who are seeking assistance, we recommend 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.

Additional tips and information about reporting problems appears on the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm. A convenient consumer guide is available there in PDF format for downloading and/or printing.

Should I be concerned about counterfeit drugs?

If you purchase your prescription medication from a licensed pharmacy—retail or mail-order—you shouldn’t worry.  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 US—outside of the FDA’s 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 phony medications.  These pharmacies exist for the sole purpose of scamming tourists from the US 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 more, visit http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

What should I do if I think my medication is counterfeit?

If you find a person or company that you think 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 presciption pharmaceutical products online and/or outside the United State.