Amneal Pharmaceuticals has made formulation and labeling changes to its generic metformin products that provide key improvements for pharmacists and patients.


Amneal Pharmaceuticals, generic metformin, blackberry flavoring, labeling, Metformin HCl Immediate Release, Metformin HCl Extended Release, Glucophage, Metformin IR, Metformin ER, Chirag Patel


































































































































































































































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Amneal updates generic metformin formula, labeling

May 16th, 2012

BRIDGEWATER, N.J. – Amneal Pharmaceuticals has made formulation and labeling changes to its generic metformin products that provide key improvements for pharmacists and patients.

The labels for Amneal's Metformin ER are getting a color background to distinguish them from the labeling on the company's Metformin IR product.

Amneal said Wednesday that it has added blackberry flavoring to its Metformin HCl Immediate Release (IR) tablets in strengths of 500, 850 and 1000 mg. The company noted that the change mitigates the smell of non-flavored metformin and was implemented after evaluating customer feedback.

The generic is therapeutically equivalent to Merck's Glucophage, indicated for the treatment of diabetes, Amneal said. Plans call for the blackberry-flavored product — which comes in 100-, 500- and 1,000-count sizes — to begin shipping this month.

To clearly identify the new blackberry-flavored Metformin IR, Amneal has assigned new NDC numbers, which have been submitted to the various agencies to ensure accurate and efficient reimbursement.

Amneal also has altered the color and design of its labels for Metformin HCl Extended Release (ER) products to differentiate them from their IR counterparts. Previously, bottles of the Metformin HCl IR 50-mg tablets looked very similar to the same-strength ER version, the company explained, noting that the similarly packaged products sitting side-by-side on a pharmacy shelf could cause confusion for a busy pharmacist and create a 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.

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, according to the company. The NDC numbers will remain the same, as will reimbursement, for all of the Metformin ER products since the change is only to the label coloring.

Amneal added that the new design format to provide distinct background colors on the labels — white for IR, and a lighter shade of the strength color for ER — will be implemented for all Amneal product families with immediate-release and controlled-release versions.

“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," stated president Chirag Patel. "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."

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