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Zhejiang Xianju Pharmaceutical Co. Ltd

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No.1, Xianyao Road, Xianju, Zhejiang, China, 317300

Xianju Pharma

Outline

Outline

I. Brief Introduction II. Quality Unit III. Production System IV. EHS System

I. Brief Introduction
Xianju Pharma

Zhejiang Xianju Pharmaceutical Co., Ltd. A professional manufacturer of steroids and hormone products with largest scale and maximum varieties in China.

A state-designated manufacturer of contraceptive drugs in China.

Company Milestones

Jan 1972 May 1997 Oct. 1999 Jun. 2000 Dec. 2001 Jan. 2010
Foundation of company Incorporated into Zhejiang Medicine Co., Ltd Listed in Shanghai Stock Market Reorganized into Xianju Pharmaceutical Co., Ltd Reformed to Zhejiang Xianju Pharmaceutical Co., Ltd listed in Shenzhen Stock Market

Location of Xianju

There are six airports around Xianju, which makes us easily accessible for our partners.

Shanghai

Headquarter Located in Xianju, Taizhou City

Hangzhou
Ningbo

Yangfu Site (FPPs) Located in Yangfu, Xianju, Taizhou City 6.8km from headquarter

Yiwu

Duqiao Site (APIs) Located in LinHai, TaiZhou City, 82.9km from headquarter

Taizhou
Wenzhou

Yangfu Site (APIs) Under construction, finish at 2017

Company Organization

General Manager

Vice G.M for Technology
Vice G.M for Administration
Vice G.M for
Finance
Vice G.M for
Sales
Vice G.M for Market
Quality Director

EHS Dept

G.M. Assistant

Production Management Dept Workshop 1, 2, 3, 4, 5, 6, 8 Purchasing Dept

G.M. Assistant

Yangfu FPP Site
Duqiao Site

Vice G.M.

(Taizhou Xianju Pharma)
Equipment Power Dept

Organization Chart

Zhejiang Xianju Pharmaceutical
Co., Ltd.

FPP Sales Company
Taizhou Xianju (wholly-owned subsidiary):491
Headquarter:1555
:1538

  • API Plant:1032
  • FPP Plant:523

Date: 2016-04-20

Staff Structure (headquarter)

The total number of headquarter (API plant) is about 1000.

Date:2016-04-20

Main APIs

Prednisolone and its derivatives Dexamethasone and its derivatives Methylprednisolone and its derivatives Triamicinolone acetonide and its derivatives Betamethasone and its derivatives Hydrocortisone and its derivatives Mometasone furoate
☆ Cortical hormones

Vecuronium Bromide Rocuronium Bromide
☆ Muscle relaxants

  • Androgen
  • Testosterone and its derivatives

Estrone
Estrogen
Estradiol and its derivatives

Progesterone
☆ Sex

hormones
Cyproterone acetate Mifepristone
Progestogen
Medroxyprogesterone acetate

Megestrol acetate Norethisterone and its derivatives

Main FPPs

Main Dosage Forms: Tablets Small Volume Injection Lyophilized Powder Injection Capsules Soft capsules Cream Gel

Main FPPs

• Reproductive health products:

Mifepristone Tablets & Soft Capsules, Misoprostol Tablets, Progesterone Capsules & Injection, Clindamycin Phosphate Vaginal Gel, Ethinylestradiol and Cyproterone Acetate Tablets, Compound Norethisterone Enanthate Injection, Compound Norethisterone Tablets and Testosterone Undecanoate Injection, etc.

• Narcotic products:

Vecuronium Bromide for Injection, Rocuronium Bromide Injection, Cisatracurium Besilate for Injection, Ropivacaine Mesylate Injection and Flumazenil Injection, etc.

• Dermatologic products:

Mometasone Furoate Cream, Beclometasone Dipropionate Cream, Hydrocortisone Butyrate Cream and Clotrimazole Betamethasone Cream, etc.

Main FPPs

• Anti-Asthmatic products:

Tiotropium Bromide Powder for Inhalation.

• Cortical hormone products:

Prednisolone Acetate Injection ,Triamcinolone Acetonide Acetate Injection, Dexamethasone Sodium Phosphate Injection, Prednisone Acetate Tables, Dexamethasone Acetate Tablets, etc.

• Other products:

Pidotimod Granules, Meloxicam Tablets , Aciclovir Tablets.

Sales revenue (by end-2015)
II. Quality Unit
Quality Policy

Xianju Pharma adheres to the tenet of
“producing first-class products, dedicated to the health of human beings”, advocating the concept of Quality- oriented, Safety and Effectiveness.

Quality Unit Organization

General Manager Quality Director

QA Manager
For API
Regulatory
Affairs Manager
Head of Quality System for Taizhou Xianju Pharma
QA Manager
For FPP
QC Manager
Manager of Quality Management Dept.

Quality Management
Dept.

Workshop QA
Workshop QA

(workshop 1, 2.

6. 8), R&D QA

(workshop 3,4,5)

Quality Management Tree

Qualification of
Quality audit of suppliers
Suppliers

Purchasing

Incoming Material Test
Material release
Storage and Release Management

Quality Control In Process of
Product quality audit
Change Management

production
Reject Management
Release of finished
Product
Quality review before Release Sales and post sales Service
Delivery or Recalls of
Products
Management of Recalled Products

Change Control, Deviation Management, Risk Management etc, are applied through out the whole product lifecycle

International Registration

APIs Registered in US FDA

U.S DMF Number

  • No.
  • Product Name
  • Status

12
Vecuronium Bromide
Prednisolone
12050 18063 19433 23934 23942 24592 25067 25606 26765 27431 30194 30230
Available for

  • reference
  • 3
  • Medroxyprogesterone Acetate

Testosterone Undecanoate
Estradiol Hemihydrate
Megestrol Acetate
456

  • 7
  • Methyl Prednisolone

  • 8
  • Testosterone Propionate

Active

  • 9
  • Rocuronium Bromide

Testosterone Enanthate
10

11 12
Prednisone
Hydrocortisone

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