PHARMACEUTICAL INDUSTRY SITE MASTER FILE

1 PHARMACEUTICAL INDUSTRY . SITE MASTER FILE. Goce Delcev 12; 2434 Novo Selo; R. Makedonija PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Good Manufacturing Practice (GMP) for finished Pharmaceuticals (WHO, EEC, PIC). Prepared by: Verified by: Approved by: Nikola Kocev Romil Sandzakoski Blagica Jakimovska _____ _____ _____. Quality Management and Environmental Management Skopje, 2010 SMF - 01 Page 1 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. CONTENTS: General Information ..33. Brief information on the firm ..44. PHARMACEUTICAL manufacturing activities as licensed by the competent Any other manufacturing activities carried out on the site ..55. Name and exact address of the site, including telephone, fax and 24 hrs telephone Type of actual products manufactured on the Short description of the Use of outside scientific, analytical or other technical assistance in relation to manufacture and Short description of the quality management system of the firm responsible for 11.

2 iso 9001 : 2008 13. ISO 14001:2004 14. iso 9001 :2000 15. GMP 16. 17. Qualifications, experience and responsibilities of key 18. Arrangements for Basic and In-service Training and how Records are 19. Health Requirements for Personnel Engaged in 19. Personnel Hygiene Requirements Including 19. Premises and 20. 22. 24. 25. Activities Course of production for solid oral drug 27. Course of production for non-sterile liquid 28. Course of production for 29. Arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and 30. 35. Quality Distribution, claims and withdrawal of 36. Self LIST OF 38. Skopje, 2010 SMF - 01 Page 2 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. GENERAL INFORMATION.

3 NAME: INTER-EVROGENEKS Novo Selo ADDRESS: Goce Delcev Str. 2434 Novo Selo Republic of Macedonia Phone: +389 2 3215 800. Fax: +389 2 3215 801. e-mail: web: Skopje, 2010 SMF - 01 Page 3 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Brief information on the firm Inter-evrogeneks, PHARMACEUTICAL INDUSTRY , was established on December 12, 1998, by M-r Ivan Gjorgjiev with head office located in Skopje, Nikola Vapcarov Str. In 1999, the factory starts with primary production of own patented herbal medical products. The company has technology for primary processing (chopping, sieving, packaging) and extraction of herbal drugs. We in Inter-evrogeneks are aware of that quality is the background of every business success and key factor of productivity and market competitiveness.

4 Production and control of pharmaceuticals are carried out in compliance with GMP requirements and other international standards, thus assuring the quality and strict compliance with environmental management standards. From October 2006, Inter-evrogeneks owns GMP certificate issued by the Ministry of Health of Republic of Macedonia. In 2006, reconstruction and modernization of factory was made, improving the capacities with new equipment for production of solid PHARMACEUTICAL forms (tablets). In September 2007, Inter-evrogeneks certified its environmental management system according to requirements of ISO 14 001 standards. The certification of our company was made also by certification company MKS MAKKONTROL from Republic of Macedonia. In January 2008 , Inter-evrogeneks certified its quality management system according to requirements of iso 9001 :2000 standards.

5 The certification of our company was made also by certification company MKS MAKKONTROL from Republic of Macedonia. In November 2009, Inter-evrogeneks certified its quality management system according to requirements of iso 9001 : 2008 standards. The certification of our company was made also by certification company SGS from Zurich, Switzerland. Inter-evrogeneks's manufacturing program is composed of medicines for human use (in form of solutions and solids for oral use). The first registrations of the products were categorized as adjuvant medical products, and from 2009, certain products are registered as herbal medicines. The quality of Inter-evrogeneks's medicines is regularly controlled by the Institute for Public Health of Republic of Macedonia and Faculty of Pharmacy - Skopje, Republic of Macedonia. Skopje, 2010 SMF - 01 Page 4 of 38.

6 PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. PHARMACEUTICAL manufacturing activities as licensed by the Competent Authorities In accordance with manufacturing activities approved by Ministry of Health of Republic of Macedonia, Inter-Evrogeneks is producing: - Finished PHARMACEUTICAL products - OTC products - Herbal products in different dosage forms Documents issued by competent authorities: - Drug marketing authorization (decision) issued by Ministry of Health of Republic of Macedonia. The document is valid for five years, counting from the date of decision's delivery - GMP and Free sale certificate for products, issued by Ministry of Health of Republic of Macedonia, certifying that the drug is marketed in manufacturer's country and that it is produced according to good manufacturing practice requirements.

7 This document is valid three years from the date of issuing. - ISO 14001:2004 certificate issued on September 2007, by MKS. MAKKONTROL Republic of Macedonia - iso 9001 :2000 certificate issued on January 2008 , by MKS MAKKONTROL. Republic of Macedonia - iso 9001 : 2008 certificate issued on November 2009, by SGS Zurich Any other manufacturing activities carried out on the site. Storage and transportation, manufacturing and sales, development. Skopje, 2010 SMF - 01 Page 5 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Name and exact address of the site, including telephone, fax and 24 hrs telephone numbers Inter-Evrogeneks. Goce Delcev 12, 2434 Novo Selo, Republic of Macedonia Telephone No. of contact person +389 2 3215 800. Fax No. of contact person +389 2 3215 801.

8 24 hour contact Telephone No. +389 70 214 296. Type of actual products manufactured on the site Type of Actual Products Manufactured Types of Inter Evrogeneks's products Solutions for peroral use 42% Solutions for external 43% use Tablets Teas 10% 5%. Skopje, 2010 SMF - 01 Page 6 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Short description of the site INTER-EVROGENEKS, NOVO SELO, REPUBLIC OF MACEDONIA. Skopje, 2010 SMF - 01 Page 7 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Inter-Evrogeneks covers the area of m2. The site is located in the Municipality of Novo Selo (located 20 km from the town of Strumica), and it borders with private agriculture land. In is on 4 km from the border of Republic of Bulgaria and 4 km from the border of Republic of Greece.

9 Surfaces of manufacturing plants are as follows: - Production plant: 1250 m2. - Storage area 1: 360 m2. - Storage area 2: 120 m2. - Storage area 3: 60 m2. - Storage area 4: 150 m2. - Area for preparation of plant material: 120 m2. Number of employees engaged in the quality assurance, production, quality control, storage and distribution TOTAL EMPLOYEES UNIVERSITY DEGREE. INTER-EVROGENEKS 10 6. Quality Assurance 1 1. Production 4 4. Quality Control 1 1. Storage and distribution 2 /. Technical & Engineering 2 /. Support Services Skopje, 2010 SMF - 01 Page 8 of 38. PHARMACEUTICAL INDUSTRY . INTER - EVROGENEKS. Goce Delcev 12; 2434 Novo Selo; R. Makedonija SITE MASTER FILE. Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis - Institute of Public Health of Republic of Macedonia Address: str.

10 50 Divizija , 1000 Skopje, Republic of Macedonia Tel.: +389 2 3 223 354. Fax.: +389 2 3 223 033. With the Institute of Public Health of Republic of Macedonia is made agreement for quality control of each batch and for any other type of analysis. - Faculty of Pharmacy Skopje Address: str. 50 Divizija , 1000 Skopje, Republic of Macedonia Tel.: +389 2 3 223 354. Fax.: +389 2 3 223 033. Inter-Evrogeneks has expert cooperation with the Institute for farmakognosy at the Faculty of Pharmacy Skopje. - Faculty of Mathematics and Natural Sciences Skopje Address: Gazi Baba bb, 1000 Skopje, Republic of Macedonia Tel.: +389 2 3 249 999. Fax.: +389 2 3 228 141. Part of the comparative analysis and determination of the validated methods are made at the Institute for chemistry at the Faculty of Mathematics and Natural Sciences Skopje. Skopje, 2010 SMF - 01 Page 9 of 38.