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Publicly Available Information: Environmental Impact Assessment Report (Draft for Comments) on the Intelligent Pilot-Scale Platform Project for Specialized, Fine, and Novel Active Pharmaceutical Ingredients at Shandong Keyuan Pharmaceutical Co., Ltd.

Publish Time:

2025-11-18

Shandong Keyuan Pharmaceutical Co., Ltd. has completed the Environmental Impact Assessment Report (Draft for Comments) of its Intelligent Pilot-Scale Platform Project for Specialty and Innovative Active Pharmaceutical Ingredients.

Shandong Keyuan Pharmaceutical Co., Ltd.
Environmental Impact Assessment Report for the Specialized, Innovative, and Novel API Intelligent Pilot-Scale Platform Project
(Draft for Public Comment) Public Information

Shandong Keyuan Pharmaceutical Co., Ltd. has completed the Environmental Impact Report (Draft for Public Comment) of its Specialized, Sophisticated, and Novel API Intelligent Pilot-Scale Platform Project. In accordance with the "Measures for Public Participation in Environmental Impact Assessment" (Ministry of Ecology and Environment Order No. 4), the following information is now being made publicly available:

(1) Basic Project Information

Project Name: Shandong Keyuan Pharmaceutical Co., Ltd. Specialized, Fine, and Innovative API Intelligent Pilot-Scale Platform Project

Construction Entity: Shandong Keyuan Pharmaceutical Co., Ltd.

Construction location: Located within the existing premises of Hongjitang Pharmaceutical (Shanghe) Co., Ltd. in Shanghe Chemical Industry Park, Jinan City, Shandong Province.

Nature of construction: Newly built

Construction details: The proposed project will include the construction of three pilot production lines. - **Pilot Line #1** will feature a pilot-scale unit for sacubitril valsartan sodium, with a capacity of 83.33 kg per batch and 48 batches per year. The pilot phase is scheduled to last one year. - **Pilot Line #2** will be equipped with a pilot-scale setup for leuprolide acetate, capable of processing 20 kg per batch, producing 400 batches annually over a one-year pilot period. - **Pilot Line #3** will house another pilot-scale unit for sacubitril valsartan sodium, with a capacity of 12.5 kg per batch and the same annual production target of 400 batches, also spanning a one-year pilot phase.

The full text of the Environmental Impact Assessment Report (Draft for Public Comment) for the Intelligent Pilot-Scale Platform Project of Specialty Pharmaceutical Raw Materials at Shandong Keyuan Pharmaceutical Co., Ltd. is available online at:

Link: https://pan.baidu.com/s/17wNKsefj29PPqLS3bxiOlg?pwd=cua6

Passcode: cua6

The Environmental Impact Assessment Report (Draft for Public Comment) of the Shandong Keyuan Pharmaceutical Co., Ltd.'s Specialized, Fine, and Innovative API Intelligent Pilot-Scale Platform Project is available at the gatehouse of Shandong Keyuan Pharmaceutical Co., Ltd. Members of the public are welcome to visit this location directly to review the paper version of the report.

(II) The public invited to provide feedback on the Environmental Impact Report (Draft for Comments) primarily includes opinions from citizens, legal entities, and other organizations within the scope of the environmental impact assessment.

(III) Members of the public invited to provide feedback can submit their comments or suggestions regarding the proposed project via the following methods:

1. Fill out the public feedback form. The online link for the public feedback form is: http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/201810/t20181024_665329.html

The public can download the public feedback form by clicking the link above or scanning the QR code. Once completed, please send it to the following email address (the public may also directly email their comments to the same address):

Construction unit email: 13608931153@139.com

Environmental Impact Assessment Unit Email: 13969115710@163.com

2. Phone contact:

Construction Unit: Shandong Keyuan Pharmaceutical Co., Ltd.

Contact for the construction unit: Manager Lin

Phone number: 13608931153

Environmental Impact Assessment Agency: Qingdao University of Science and Technology

Contact for the Environmental Impact Assessment Unit: Manager Qi

Phone number: 13969115710

3. Send a letter:

Address: Shandong Keyuan Pharmaceutical Co., Ltd. (Sent to) Shanghe Chemical Industry Park, Shanghe Economic Development Zone, Jinan City, Shandong Province Postal Code: 262724 Phone: 19806362883

(Four) The period for public comments this time is from November 18, 2025, to November 24, 2025, totaling 5 working days.

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