Oral Solid Preparation Workshop Pilot Technical Transformation Project – Public Comment Draft Announcement

Date: 2024-10-16 15:47:33

I. Project Overview

1. Project Name: Shijiazhuang Longze Pharmaceutical Co., Ltd. Oral Solid Preparation Workshop Pilot Technical Transformation Project

2. Nature of Construction: Technical Transformation

3. Construction Location: Within the existing site of Shijiazhuang Longze Pharmaceutical Co., Ltd.

4. Main Construction Content and Scale: Based on the original plant building and equipment, this project will add pilot production for eight products through technical transformation, including: Tenofovir Alafenamide Fumarate (TAF) 5000 kg/a, Pregabalin 5000 kg/a, PL-01 480 kg/a, Vortioxetine Hydrobromide 400 kg/a, Brexpiprazole 260 kg/a, Apalutamide 480 kg/a, Piribedil 480 kg/a, and Pranoprofen (6701) 360 kg/a.

5. Existing Facilities and Environmental Protection Status: Longze Pharmaceutical covers a total area of 100,392.97 m². Existing products include: Lamivudine API (100 t/a), Lamivudine preparations (1 billion tablets/year), Tenofovir Disoproxil Fumarate tablets (1 billion tablets/year), Tenofovir Alafenamide Fumarate tablets (100 million tablets/year), Pregabalin capsules (2.5 billion capsules), Tenofovir Disoproxil Fumarate API (50 t/a), Esomeprazole API (30 t/a), Paroxetine Hydrochloride API (30 t/a), Esomeprazole tablets (1 billion tablets/year), and Paroxetine Hydrochloride tablets (1 billion tablets/year).

The company currently holds a Pollutant Discharge Permit issued by the Shijiazhuang Administrative Examination and Approval Bureau, valid from June 25, 2024, to June 24, 2029. The permit number is 91130100796583829Y001P.

II. Construction Unit and Contact Information

Construction Unit: Shijiazhuang Longze Pharmaceutical Co., Ltd.

Contact Person: Liu Weichao

Contact Number: 15230199985

Address: No. 16, Xihuan Road, Shenze County Industrial Park

Email: 15230199985@163.com

III. Environmental Impact Assessment Report Compilation Unit

Zhonglan Zhixin Environmental Protection Technology Co., Ltd.

IV. Scope of the Public Solicited for Comments

Sensitive environmental elements within the assessment area.

V. Online Links to the Full Public Comment Draft of the Environmental Impact Report and the Public Opinion Form, and Methods for Accessing the Paper Report

Online Link: https://pan.baidu.com/s/1ZSzxG-v5uvcZwG9XDG6FOA?pwd=tgfn

Extraction Code: tgfn

Method for accessing the paper report: The construction unit will place the full public comment draft of the Environmental Impact Report at the Shijiazhuang Longze Pharmaceutical Co., Ltd. plant for review. The full public comment draft can also be obtained by contacting the construction unit.

VI. Methods for Submitting the Public Opinion Form

The public can submit opinions and suggestions on this project to the construction unit by phone, mail, or email.

VII. Timeframe for Public Comments

From October 16, 2024, to October 29, 2024.