Our company obtained the drug production license issued by the Sichuan Food and Drug Administration on September 13, 2016. On August 10 of the same year, the State Food and Drug Administration issued the Announcement of the General Administration on the relevant matters of the review and approval of pharmaceutical packaging materials and pharmaceutical excipients (No. 134 of 2016). The announcement pointed out that in order to simplify the drug approval process, packaging materials and containers (hereinafter referred to as drug packaging materials) and pharmaceutical excipients that come into direct contact with drugs will be reviewed and approved together when approving drug registration applications instead of separately. Since the date of this announcement, pharmaceutical packaging materials and pharmaceutical excipients shall be declared, reviewed and approved in accordance with the procedures associated with drug registration applications. Food and drug supervision and administration departments at all levels will no longer accept registration applications for pharmaceutical packaging materials and pharmaceutical excipients separately, and will no longer issue relevant registration approval documents separately.

On November 30, 2017, the State Food and Drug Administration issued the Announcement on the adjustment of the review and approval of raw materials, pharmaceutical excipients and pharmaceutical packaging materials (No. 146 of 2017). From the date of the announcement, the food and drug administration departments at all levels will no longer accept the registration application for raw materials, pharmaceutical excipients and pharmaceutical packaging materials separately. Cancel the approval of pharmaceutical excipients and packaging materials and containers in direct contact with drugs (hereinafter referred to as pharmaceutical packaging materials).

Therefore, after getting the drug manufacturing license, our company filed an appeal, did not declare the production registration approval document, and directly carried out the "original and auxiliary package registration" in accordance with the new regulations. On March 8, 2018, after submitting the electronic registration information on the original and auxiliary package registration platform (www.cde.org.cn), we obtained the registration number: F20180000548. And according to the application data requirements of pharmaceutical excipients (No. 155 in 2016) to write the application data, the data will be mailed to the State Food and Drug Administration drug evaluation center, the drug evaluation center for my company to meet the requirements of the audit data, in the "pharmaceutical excipients database" published my company registration number and other relevant information. You can log on to the official website of the Center for Drug Review and Approval of the State Food and Drug Administration (www.cde.org.cn), and find relevant information in the Registration information Publicity of apis, pharmaceutical excipients and pharmaceutical packaging materials in the hot column on the right side of the home page.

When cooperating with pharmaceutical manufacturers, pharmaceutical excipients and pharmaceutical excipients shall be reviewed together with the preparations in accordance with the Circular on the Release of Application data Requirements for Pharmaceutical excipients (Trial) of the State Administration of China (No. 155 of 2016). The General Administration shall organize verification units to initiate on-site inspection and registration inspection of the raw and auxiliary packages used in the preparation as required, and the on-site inspection and registration inspection shall comply with the relevant provisions.

In the supply cooperation of raw materials, pharmaceutical excipients, pharmaceutical packaging materials manufacturers directly provide our company's registration information publicized on the registration platform, and manufacturers can review and enter the supplier if they meet the requirements.

Hereby state

Chengdu classic gelatin Co., LTD

May 31, 2018