<p><strong>No.1, Xianyao Road, Xianju, Zhejiang, China, 317300 </strong></p><p>Xianju Pharma </p><p><strong>Outline </strong></p><p>Outline </p><p>I. Brief Introduction II. Quality Unit III. Production System IV. EHS System </p><p>I. Brief&nbsp;Introduction <br>Xianju Pharma </p><p><strong>Zhejiang Xianju Pharmaceutical Co., Ltd. </strong><strong>A professional manufacturer of steroids and hormone products with largest scale and maximum varieties in China. </strong></p><p><strong>A state-designated manufacturer of contraceptive drugs in China. </strong></p><p>Company Milestones </p><p><strong>Jan 1972 May 1997 Oct. 1999 Jun. 2000 Dec. 2001 Jan. 2010 </strong><br><strong>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 </strong></p><p>Location of Xianju </p><p><strong>There are six airports around Xianju, which makes us easily accessible for our partners. </strong></p><p><strong>Shanghai </strong></p><p><strong>Headquarter Located in Xianju, Taizhou City </strong></p><p><strong>Hangzhou </strong><br><strong>Ningbo </strong></p><p><strong>Yangfu Site (FPPs) Located in Yangfu, Xianju, Taizhou City 6.8km from headquarter </strong></p><p><strong>Yiwu </strong></p><p><strong>Duqiao Site (APIs) Located in LinHai, TaiZhou City, 82.9km from headquarter </strong></p><p><strong>Taizhou </strong><br><strong>Wenzhou </strong></p><p><strong>Yangfu Site (APIs) Under construction, finish at 2017 </strong></p><p>Company Organization </p><p><strong>General Manager </strong></p><p><strong>Vice G.M for Technology </strong><br><strong>Vice G.M for Administration </strong><br><strong>Vice G.M for </strong><br><strong>Finance </strong><br><strong>Vice G.M for </strong><br><strong>Sales </strong><br><strong>Vice G.M for Market </strong><br><strong>Quality Director </strong></p><p><strong>EHS Dept </strong></p><p><strong>G.M. Assistant </strong></p><p><strong>Production Management Dept Workshop 1, 2, 3, 4, 5, 6, 8 Purchasing Dept </strong></p><p><strong>G.M. Assistant </strong></p><p><strong>Yangfu FPP Site </strong><br><strong>Duqiao Site </strong></p><p><strong>Vice G.M. </strong></p><p><strong>(Taizhou Xianju Pharma) </strong><br><strong>Equipment Power Dept </strong></p><p>Organization Chart </p><p><strong>Zhejiang Xianju Pharmaceutical </strong><br><strong>Co., Ltd. </strong></p><p><strong>FPP Sales Company </strong><br><strong>Taizhou Xianju (wholly-owned subsidiary):491 </strong><br><strong>Headquarter:1555 </strong><br><strong>:1538 </strong></p><p></p><ul style="display: flex;"><li style="flex:1"><strong>API Plant:1032 </strong></li><li style="flex:1"><strong>FPP Plant:523 </strong></li></ul><p></p><p><strong>Date: 2016-04-20 </strong></p><p>Staff Structure (headquarter) </p><p><strong>The total number of headquarter (API plant) is about 1000. </strong></p><p><strong>Date:2016-04-20 </strong></p><p><strong>Main APIs </strong></p><p><strong>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 </strong><br><strong>☆ Cortical hormones </strong></p><p><strong>Vecuronium Bromide Rocuronium Bromide </strong><br><strong>☆ Muscle relaxants </strong></p><p></p><ul style="display: flex;"><li style="flex:1"><strong>Androgen </strong></li><li style="flex:1"><strong>Testosterone and its derivatives </strong></li></ul><p><strong>Estrone </strong><br><strong>Estrogen </strong><br><strong>Estradiol and its derivatives </strong></p><p><strong>Progesterone </strong><br><strong>☆ Sex </strong></p><p><strong>hormones </strong><br><strong>Cyproterone acetate Mifepristone </strong><br><strong>Progestogen </strong><br><strong>Medroxyprogesterone acetate </strong></p><p><strong>Megestrol acetate Norethisterone and its derivatives </strong></p><p>Main FPPs </p><p><strong>Main Dosage Forms: </strong><strong>Tablets </strong><strong>Small Volume Injection </strong><strong>Lyophilized Powder Injection </strong><strong>Capsules </strong><strong>Soft capsules </strong><strong>Cream </strong><strong>Gel </strong></p><p>Main FPPs </p><p>• <strong>Reproductive health products: </strong></p><p>Mifepristone Tablets &amp; Soft Capsules, Misoprostol Tablets, Progesterone Capsules &amp; Injection, Clindamycin Phosphate Vaginal Gel, Ethinylestradiol and Cyproterone Acetate Tablets, Compound Norethisterone Enanthate Injection, Compound Norethisterone Tablets and Testosterone Undecanoate Injection, etc. </p><p>• <strong>Narcotic products: </strong></p><p>Vecuronium Bromide for Injection, Rocuronium Bromide Injection, Cisatracurium Besilate for Injection, Ropivacaine Mesylate Injection and Flumazenil Injection, etc. </p><p>• <strong>Dermatologic products: </strong></p><p>Mometasone Furoate Cream, Beclometasone Dipropionate Cream, Hydrocortisone Butyrate Cream and Clotrimazole Betamethasone Cream, etc. </p><p>Main FPPs </p><p>• <strong>Anti-Asthmatic products: </strong></p><p>Tiotropium Bromide Powder for Inhalation. </p><p>• <strong>Cortical hormone products: </strong></p><p>Prednisolone Acetate Injection ,Triamcinolone Acetonide Acetate Injection, Dexamethasone Sodium Phosphate Injection, Prednisone Acetate Tables, Dexamethasone Acetate Tablets, etc. </p><p>• <strong>Other products: </strong></p><p>Pidotimod Granules, Meloxicam Tablets , Aciclovir Tablets. </p><p>Sales revenue (by end-2015) <br>II. Quality Unit <br>Quality Policy </p><p><strong>Xianju Pharma adheres to the tenet of </strong><br><strong>“producing first-class products, dedicated to the health of human beings”, advocating the concept of Quality- oriented, Safety and Effectiveness. </strong></p><p>Quality Unit Organization </p><p><strong>General Manager Quality Director </strong></p><p><strong>QA Manager </strong><br><strong>For API </strong><br><strong>Regulatory </strong><br><strong>Affairs Manager </strong><br><strong>Head of Quality System for Taizhou Xianju Pharma </strong><br><strong>QA Manager </strong><br><strong>For FPP </strong><br><strong>QC Manager </strong><br><strong>Manager of Quality Management Dept. </strong></p><p><strong>Quality Management </strong><br><strong>Dept. </strong></p><p><strong>Workshop QA </strong><br><strong>Workshop QA </strong></p><p><strong>(workshop 1, 2. </strong></p><p><strong>6. 8), R&amp;D QA </strong></p><p><strong>(workshop 3,4,5) </strong></p><p>Quality Management Tree </p><p><strong>Qualification of </strong><br><strong>Quality audit of suppliers </strong><br><strong>Suppliers </strong></p><p><strong>Purchasing </strong></p><p><strong>Incoming Material Test </strong><br><strong>Material release </strong><br><strong>Storage and Release Management </strong></p><p><strong>Quality Control In Process of </strong><br><strong>Product quality audit </strong><br><strong>Change Management </strong></p><p><strong>production </strong><br><strong>Reject Management </strong><br><strong>Release of&nbsp;finished </strong><br><strong>Product </strong><br><strong>Quality review before Release Sales and post sales Service </strong><br><strong>Delivery or Recalls of </strong><br><strong>Products </strong><br><strong>Management of Recalled Products </strong></p><p><strong>Change Control, Deviation Management, Risk Management etc, are applied through out the whole product lifecycle </strong></p><p><strong>International Registration </strong></p><p><strong>APIs Registered in US FDA </strong></p><p><strong>U.S DMF Number </strong></p><ul style="display: flex;"><li style="flex:1"><strong>No. </strong></li><li style="flex:1"><strong>Product Name </strong></li><li style="flex:1"><strong>Status </strong></li></ul><p></p><p>12<br>Vecuronium Bromide <br>Prednisolone <br>12050 18063 19433 23934 23942 24592 25067 25606 26765 27431 30194 30230 <br>Available for </p><ul style="display: flex;"><li style="flex:1">reference </li><li style="flex:1">3</li><li style="flex:1">Medroxyprogesterone Acetate </li></ul><p>Testosterone Undecanoate <br>Estradiol Hemihydrate <br>Megestrol Acetate <br>456</p><ul style="display: flex;"><li style="flex:1">7</li><li style="flex:1">Methyl Prednisolone </li></ul><p></p><ul style="display: flex;"><li style="flex:1">8</li><li style="flex:1">Testosterone Propionate </li></ul><p>Active </p><ul style="display: flex;"><li style="flex:1">9</li><li style="flex:1">Rocuronium Bromide </li></ul><p>Testosterone Enanthate <br>10 </p><p>11 12 <br>Prednisone <br>Hydrocortisone </p>