福安药业集团

烟台只楚药业有限公司
Fuan Pharmaceutical GROUP

Yantai Justaware Pharmaceutical Co.,Ltd .

C 目
ONTENTS
录

Company Introduction Product

International Market

Organization Chart Quality Management

Gentamicin Sulfate Registration & Certification

Production

Accompanying Leaders
1. COMPANY INTRODUCTION
1. 公司介绍

公司地址：
中国山东省烟台市芝
罘区烟福路1号
Company address：
No.1 Yanfu Road,
Zhifu District,
Yantai City,
Shandong Province,
China
1. COMPANY INTRODUCTION
1. 公司介绍

Fuan Pharmaceutical Group Yantai Justaware Pharmaceutical Co., Ltd is a

comprehensive pharmaceutical company invested in 1990. It mainly engages in
manufacturing and distributing API, Western formulation、natural drugs and its
future developing field is biological engineering.
福安药业集团烟台只楚药业有限公司于1990年
兴建，以生产原料药为主，以西
药制剂、天然药物及生物工程为
发展方向的综合性制药企业。
1. COMPANY INTRODUCTION
1. 公司介绍

The company covers an area of

120,000 square meters with a
construction area of 83,000 square
meters，registered capital RMB
240,160,100.
公司占地120,000平方米，建筑
面积83,000平方米，注册资本
24016.01万元。
1. COMPANY INTRODUCTION
1. 公司介绍

The company owns more than 80 different specifications products certificates.

There are API manufacturing plant， Lyophilized powder for injection plant，
Small Volume Solution for injection plant，oral solid dosage plant and other
auxiliary plant. And the annual output of is API 700 tons, capsules 50 million,
granules 6 million， tablets 1 billion, small volume solution 250 million, and
Lyophilized powder 25 million.
公司拥有80多个不同规格、品种的产品批准文号，现有原料药车间、冻干
粉针剂车间、小容量注射剂车间、口服固体制剂车间及其辅助车间，年生
产能力为原料药700吨，胶囊剂5,000万粒，颗粒剂600万袋，片剂10亿片，
小容量注射剂2.5亿支、冻干粉针剂2,500万支。
2. PRODUCT INTERNATIONAL MARKET
2. 产品国际市场

Fuan Pharmaceutical Group Yantai

Justaware Pharmaceutical Co., Ltd is
the largest producer and exporter of
Gentamicin Sulfate in China.
福安药业集团烟台只楚药业有限公司
是中国最大的硫酸庆大霉素生产商和
出口商。
2. PRODUCT INTERNATIONAL MARKET
2. 产品国际市场

Canada
Russia
Holand
Poland
Germany
Czech
Italy
Turkey South
Lebanan China
Tunisia Iran Korea
Israel
Pakistan
Egypt Nepal
Mexico Saudi Arabia India Bangladesh
Viatnam
Thailand
GhanaNigeria Ethiopia Philippine
Columbia Uganda Malaysia
Congo Kenya
Tanzania
Brazil Zambia
Moçambique
Botswana
Chile
Argentina
2. PRODUCT INTERNATIONAL MARKET
2. 产品国际市场

加拿大
俄罗斯
加拿大 荷兰
波兰
德国
捷克
意大利
土耳其
黎巴嫩 中国 韩国
突尼斯
以色列
巴基斯坦
埃及 尼泊尔
墨西哥 沙特 孟加拉国
墨西哥 越南
泰国
加纳 尼日利亚 埃塞俄比亚 菲律宾
哥伦比亚 乌干达 马来西亚
哥伦比亚 刚果 肯尼亚

巴西 赞比亚
巴西 莫桑比克
博茨瓦
纳
智利
智利
阿根廷
阿根廷
3. ORGANISATION CHART
3. 组织机构
3. ORGANISATION CHART
3. 组织机构
4. Quality Management

•Quality vice-manager is directly led by general manager， and authorized to

be responsible for the implementation of the quality system effectively. This
makes sure that any department and personnel is forbidden to hinder and
interfere with the execution of quality authority.
质量副总经理直属总经理领导，总经理授权质量副总经理全面负责公
司质量体系的有效运行，并保证任何个人和部门不允许干扰或妨碍其独
立行使质量职权。
• Quality department is directly in charge of quality vice-manager （also
Qualified Person) ，including QA ，QC and regulatory & registration
departments. Qualified Person is authorized to release products.
质量部由质量副总经理兼质量受权人直接管理，包括QA部门，QC部门
和法规注册部，质量受权人被授权批准放行公司产品.

•There are adequate QA and QC staffs appropriate to the production scale。

QA Staff Number is 17, QC Staff Number is 51.
QA，QC人员数量与生产规模相适应， QA人数17人， QC人数为51人。
4. Quality Management

Quality control center has specific physical and chemical room,

retention sample room, balance room, reference solution room,
instruments room, stability testing room, bacterial endotoxin
testing room, microbial testing room，sterility testing room,
potency testing room etc, to satisfy the testing needs of all products.

质检中心设有专门的理化室、留样室、天平室、标准溶液室、
仪器室、稳定性考察室、细菌内毒素检测室、微生物检测室、
无菌检查室、效价检测室等，完全能够满足所有产品的检测需
求。

• Quality control center is assembled with more than 20 sets of

quality test instruments, such as HPLC, GC，IR, UV，TOC etc.
质检中心配有20多套质量检验设备,如高效液相、气相、红外、
紫外、总有机碳分析仪等。
4. Quality Management

Agilent GC Agilent HPLC

安捷伦 气相色谱仪 安捷伦 液相色谱仪
4. Quality Management

TOC analyzer Atomic-absorption

spectrophotometer
TOC 分析仪
原子吸收分光光度计
4. Quality Management

Thermo Scientific
Ion chromatograph Incubating room
赛默飞 离子色谱仪 培养室
5. Gentamicin sulfate Production

• There are dedicated plant and equipments

for Gentamicin Sulfate manufacturing.
• 专用车间和设备生产硫酸庆大霉素。

Fermentation Concentration
5. Gentamicin sulfate Production

Clean-room
5. Gentamicin sulfate Production

Packaging

Powder collection
6. Registration and Certification
6. 注册及认证

• Plants for Gentamicin Sulfate, Lovastatin,

Tablets, Capsules，Granules， Small Volume
Solution and Lyophilized powder for injection，
We have all gotten national GMP certificates
from CFDA（China Food and Drug
Administration）.
硫酸庆大霉素、洛伐他汀、片剂、胶囊剂、
颗粒剂、小容量注射剂和冻干粉针剂车间
均获得了国家、省食品药品监督管理局颁
发的药品GMP证书。
6. Registration and Certification
6. 注册及认证
6. Registration and Certification
6. 注册及认证
6. Registration and Certification
6. 注册及认证
6. Registration and Certification
6. 注册及认证

• Gentamicin sulfate DMF（ASMF）

• 硫酸庆大霉素DMF
• Based on related regulations or guidelines，we establish gentamicin
sulfate DMF document (open part, and restricted part).
• 依据相关的法规或指南，我们制定了硫酸庆大霉素DMF文件（公开部
分和保密部分）。
• Guideline on Active Substance Master File Procedure（EMA，May，
2013）
• THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF
PHARMACEUTICALS FOR HUMAN USE: QUALITY – M4Q(R1) QUALITY
OVERALL SUMMARY OF MODULE 2 MODULE 3 : QUALITY
7. Accompanying Leaders 陪同领导

• Jinhai Hao : QA manager

郝金海： QA 经理
Pharmacy bachelor, 10 years QC and more than 10 years QA experiences, rich in
management of drug substance and drug product manufacturing and
quality-assurance , and responsible for drug GMP certification for many times.
药学学士，十年QC经验，10多年QA经验，有着丰富的原料药和制剂生产、
质量管理经验，负责多次药品GMP认证工作。

• Zhaoxia Zheng : Regulatory manager

郑召霞：法规部经理
Chemical Engineering, 10 years production and more than 10 years medicine
registration experiences, familiar with Chinese GMP, FDA cGMP, EU-GMP and ICH
related regulations.
化学工程专业，十年生产经验、10多年的药品注册经验，熟悉中国GMP、FDA
cGMP、欧洲GMP及ICH等法规。
THANK YOU