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Page 1/28 ××× Site Master File Issu e Date: 1/8/2009 Issu e No.: 001 SITE MASTER FILE Sign./Date Position Name QA Manager Complied By Plant Manager Approved By Managing Director Authorized By Page 2/28 ××× Site Master File Issue Date: 1/8/2009 Issue No.: 001 1. GENERAL INFORMATION 1.1. Brief Information About ××× Pharmaceuticals Company: ××× is a highly fast growing pharmaceutical company with several production lines. It was established in 2000 under the investment law No. 8 for the year 1997. It is owned by a well reputed businessman in the medical and pharmaceutical fields, In zhejiang province china; Mr. ×××, the chairman of the company. The capital money of the company is seven million dollars. ××× a very well experienced pharmacist in the pharmaceutical industries, is the Managing Director. ××× in the first phase started manufacturing Empty Hard Gelatin Capsule, and different solid dosage forms pharmaceutical products (Tablets, Capsules and Effervescent products). The Empty Hard Gelatin Capsule is produced according to the recent advanced technology of Empty Hard Gelatin Capsule production provided by Technophar -Canada, which is one of the largest company through out the world in the field of Hard Gelatin Capsule Technology . ××× solid dosage forms production area is divided into two major sections: a) Tablets (uncoated and coated) and Capsules . b) Humidity controlled area for the production of effervescent products. In the second phase, additional production lines for Liquid Syrups, Suspensions, Ointments, Creams and Lotions will be completed. In the third phase, Ampoules and eye drops lines, and a separated antibiotics plant will be completed. ××× recruited a very hi...