Amneal Builds on Customer Input to Upgrade Generic Metformin Labeling

Amneal Pharmaceuticals, LLC today announced significant formulation and labeling changes to its generic Metformin products, offering substantial improvements in these medications for both pharmacists and their patients.

Amneal has added blackberry flavoring to its Metformin HCl Immediate Release (IR) tablets in 500, 850 and 1000 mg strengths. The formulation change to add the new flavor, which imparts a pleasant taste and aroma, mitigates the smell of non-flavored Metformin and was implemented after evaluating candid customer feedback regarding the inherent smell of the API (active pharmaceutical ingredient). Amneal’s generic is a therapeutically equivalent alternative to Glucophage® (a registered trademark of Merck Santé S.A.S.), indicated for treatment of diabetes.

Manufactured in Amneal’s fully cGMP-compliant Brookhaven, NY facility, blackberry-flavored Metformin HCl IR tablets in 100, 500 and 1000 count sizes will begin shipping in May and will be available through wholesalers-distributors as well as directly to the trade. To clearly identify the new blackberry-flavored Metformin IR, the company has assigned new NDC numbers, which have been submitted to the various agencies to ensure accurate and efficient reimbursement.

In another example of proactively using input from pharmacists to increase customer value, Amneal has altered the color and design of its labels for Metformin HCl Extended Release (ER) products to clearly and definitively differentiate them from their IR counterparts. Previously, bottles of the company’s Metformin HCl IR 500 mg tablets appeared very similar to the same-strength ER version. Side-by-side on a pharmacy shelf, the look-alike packaging could cause confusion for a busy pharmacist reaching for the bottle to count out a prescription, creating a possible risk of dispensing errors.

Amneal redesigned the labels for its Metformin ER with a distinct background and color block around the NDC to thoroughly distinguish the IR and ER forms without any change to product or label content (see attached image).

In mid-March Amneal began shipping newly-labeled Metformin HCl ER tablets in 500 and 750 mg strengths, and customers should start seeing the new label as current inventory is depleted. Since this change is only to the label coloring, the NDC numbers will remain the same, as will reimbursement, for all of the Metformin ER products.

The new design format to provide distinct background colors on the labels (white for IR/ a lighter shade of the strength color for ER) will be implemented not only for Metformin products, but for all Amneal product families with both immediate release and controlled release versions. Customers can view and download all product labels in Amneal’s web catalog at amneal.com/products.

“The Metformin IR flavor change and Metformin ER label change are just the latest examples of Amneal’s commitment to continuous improvement and generating ever-greater customer value,” said Chirag Patel, Amneal’s president. “Amneal is dedicated to building strong customer relationships based on responsiveness, openness and candor. We listen closely to feedback from pharmacists on behalf of their patients as well as our direct customers, then implement improvements that increase value and/or mitigate potential hurdles for complete customer satisfaction.”

Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation”, Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S., as well as abroad. For more information, visit amneal.com.

Source: Amneal Pharmaceuticals LLC