On September 14, 2021, Tai Heng received an official letter from the US FDA regarding the Product DMF (#028142) of Fingolimod Hydrochloride. The letter states that FDA has completed its review of our product and determined that the DMF information is complete enough to support the ANDA application in the U.S.

Tai Heng hereby undertakes to promptly report to FDA and inform our customers of any future changes to this DMF in strict accordance with 21 CFR 314.420(c).