Shandong Xinhua Pharmaceutical Company Limited has recently received the Notification of Approval of Application for Marketing of Active Pharmaceutical Ingredients issued by the National Medical Products Administration in relation to prednisone (hereinafter referred to as the "Product"). Relevant information is now announced as follows: Drug name: Prednisone, Dosage form: Active Pharmaceutical Ingredients, Registration category: Chemicals, Applicant: Shandong Xinhua Pharmaceutical Company Limited, Application matter: Application for marketing of domestic produced chemical Active Pharmaceutical Ingredients. In April 2022, Xinhua Pharmaceutical submitted the registration application materials to the National Medical Products Administration concerning the application for registration for marketing of domestically produced chemical Active Pharmaceutical Ingredigents in connection with its prednisone, and the application materials were accepted.

In February 2024, Xinhua Pharmaceutical received the Notification of Approval for Application for Marketing of Active Pharmaceutical Ingredients with the review conclusion that the production of the Product has been approved. This product has been already been marketed both domestically and internationally. The prednisone tablet of West-Ward Pharmaceuticals International Ltd. is a similar drug type which is recognised internationally and has been published in the Orange Book of the United States of America, being referenced preparations as published by the National Medical Products Administration.

The prednisone tablets of that company has subsequently been transferred to Hikma Pharmaceuticals USA Inc.