Amneal Receives FDA Approval for Indomethacin ER Capsules

Four sizes offer flexibility for a variety of dispensing needs

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, LLC is pleased to announce that it received U.S. FDA approval for Indomethacin Extended Release capsules, USP in the 75 mg strength effective December 1, 2010. The product is available in 30, 60, 90 and 500-count sizes to conveniently meet the needs of different pharmacy segments and prescription dispensing options. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Indocin® SR (a registered trademark of Merck & Co.). Annual U.S. sales of Indomethacin ER capsules were $41.5 million as of October 2010 according to IMS Health market data.

Four sizes of Amneal’s Indomethacin ER capsules provide flexible solutions for almost every type of script and pharmacy:

  • 30-count for the most common prescription size, a single month unit-of-use
  • 60-count for the second most common script, twice-daily intake
  • 90-count for a larger drugstore inventory or a three-month prescription (for mail service)
  • 500-count for high-volume and automated pharmacies

Amneal is now shipping Indomethacin ER, available through wholesalers-distributors as well as directly to the trade. The finished product is produced in Brookhaven, NY, one of the company’s five fully cGMP-compliant manufacturing plants in New York and New Jersey, USA.

“Introducing Indomethacin ER in four different sizes is a direct reflection of Amneal’s customer-centric philosophy,” said Chirag Patel, President of Amneal. “Through close collaboration with our customers, we identified the most appropriate sizes to offer. Besides the commonly-used 60, 100 and 500-counts, we added 30-count and switched from 100 to 90-count for more efficient unit-of-use and mail order dispensing. We continuously work to demonstrate our commitment to delivering new products and services that best serve the needs of pharmacies and our mutual and ultimate customers, the patients.”

Indomethacin ER capsules join Amneal’s fast-growing family of superb quality generic drugs in the company’s on-line catalog at The comprehensive web catalog is designed for easy customer and patient access to essential information, images and literature such as product outserts, labels, patient medication guides, MSDS (material safety data sheets) and high-resolution product photos.

Amneal Pharmaceuticals, LLC, with principal offices in Bridgewater, NJ, is a U.S.-based firm that develops, manufactures and distributes generic pharmaceuticals regulated and approved by the U.S. FDA. Known as “Generic’s New Generation,” the company utilizes its newly expanded R&D and manufacturing capabilities to conceive breakthrough developments with lasting impact for a robust product pipeline. Rapid ANDA approvals and diverse product acquisitions are key to Amneal’s aggressive growth strategy, as is the company’s strong commitment to deep customer relationships and maximum value creation. Amneal delivers high quality products, superior service levels and dynamic value throughout the pharmaceutical industry. For more information, visit


Amneal Pharmaceuticals, LLC
Jim Luce
Executive Vice President, Sales & Marketing
Direct: 949-610-8018
Fax: 949-610-8218
E-mail: [email protected]

KEYWORDS:   United States  North America  New Jersey

INDUSTRY KEYWORDS:   Practice Management  Health  Hospitals  Pharmaceutical  FDA  Managed Care