2021-10
TWi’ ANDA for Metformin HCl Extended-Release Tablets (equivalent to Fortamet®) has been officially approved by US FDA

October 1, 2021 TWi Pharmaceuticals, Inc. (“TWi”) today announced that its ANDA (“Abbreviated New Drug Application”) for Metformin HCl Extended-Release Tablets (equivalent to Fortamet®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

 
Metformin HCl Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. According to IQVIA data, the total sales of Metformin HCl Extended-Release Tablets/Fortamet® in the US were approximately US $31.8 million for the 12 months ended August 2021.
 
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier to entry generic prescription products ranging from oral controlled release dosage forms to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer unparalleled market opportunities in the United States. For more information on TWi Pharmaceuticals and its fully owned US subsidiary, TWi Pharmaceuticals USA, Inc., please visit www.twipharma.com

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