Huadong Medicine Acarbose Tablets Obtained U.S. FDA Approval Number

Introduction: Akapo sugar tablets are currently an important variety in the field of diabetes in East China.
. Today, East China Pharmaceuticals announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has approved a brief application for a new drug (ANDA, or U.S. generic drug application) for oral solid preparations of Acapo sugar tablets filed with the FDA.
Acapo sugar is an alpha-glycosidease inhibitor originally developed by Bayer Pharmaceuticals of Germany, listed in Germany in 1990, approved for listing in China in 1994 and approved and listed by the FDA in 1995.
Akapo sugar, as an oral hypoglycemic drug, can competitively inhibit glucosine hydrolysase in the intestines, inhibit starch decomposition into glucose, thereby reducing the absorption of glucose in the intestines, thereby alleviating post-meal hyperglycemia, to reduce the role of blood sugar.
is currently an important variety in the field of diabetes in East China, with global sales of Acapo sugar preparation products of $689 million in 2019.
Akapo sugar tablets produced in East China, China and the United States were the first in China to be approved for listing in the Austrian market in the European Union in December 2019 through the evaluation of the quality and efficacy of generic drugs.
This application for Acapo sugar tablets was submitted in October 2019 and approved by the FDA in August 2020, making it the first FDA approved by the U.S. FDA for domestic Acapo sugar preparation products and the first Acapo sugar preparation product to be licensed in both China, the U.S. and the European Union in Austria.
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