creating value from design to production

Transcription

1 creating value from design to production

2 history - development through innovation GAP SA. is one of the oldest manufacturers of pharmaceutical in Greece, which demonstrates successful and uninterrupted operation for more than a half of century. The company was founded in 1949 by the brothers Georgios and Athanasios Papathanasiou, who continued the long family tradition of pharmacists, going back to the 19 th Century. From the first day of its operation until today, GAP remains undoubtedly committed to a basic code of principles, emphasizing quality, safety, efficacy and innovation of its products. together in health and in innovation since 1949

3 GAP today - manufacturing capabilities GAP manufactures its products exclusively in wholly-owned facilities covering 5,500 m² in Athens, Greece adhering to GMP, GLP, GDP and HACCP requirements. GAP manufacturing capability covers a wide range of forms, as: - soft gelatine capsules (Rx, OTC, hormonal, food supplements and cosmetics) - tablets (film coated, gastro resistant) - hard capsules (sustain release pellets) - injectables (ampoules and prefilled syringes ) - veterinary GAP as vertically integrated, employs areas production, technical support, quality control, R&D, storage and distribution combining flexibility with efficiency

4 GAP today - 3 business units GAP is a vertically integrated pharmaceutical company that operates in 3 principal areas: 1. Contract manufacturing of soft capsules in its state-ofthe-art equipped facilities 2. Development, Production and distribution of generic and innovative pharmaceuticals in the Greek and international markets. 3. Development and distribution of EVIOL branded products (vitamins, food supplements, cosmetics). A dedicated personnel of 220 highly trained people, utilize their experience for the developing, manufacturing, marketing and exporting supreme quality of products and services. quality & reliability guaranteed regardless the challenges

5 GAP today- examples of our major achievements: GAP is one of the largest European contract manufacturers of Isotretinoin with an annual production of 200 million capsules GAP, today is the No.3 healthcare professionals choice in the TOTAL Greek Market of Generic Preparations GAP dominates CVS & CNS category in Greece GAP Branded Food Supplements B Complex & Brain Function soft gelatine rank as the fastest growing in their respective categories GAP holds over 60% market share for Vitamin E soft gel caps in Greece. GAP ranks within the top 50, in terms of financial stability, development rate and employees satisfaction in Greece GAP is within the top 150 manufacturers of generics in Europe quality & reliability guaranteed regardless the challenges

6 contract manufacture - soft gelatine capsules One of the major and more dynamic activities of GAP is the contract manufacturing of soft gelatin capsules. Through our long experience in soft gelatin development and innovation, that goes back to the 1970s, GAP remains the only such manufacturer in Greece and one of the few in Europe capable of offering such flexible and costeffective services under EU GMP and HACCP. We serve as CMO for numerous partners in Europe (Austria, Bulgaria, Croatia, France, Germany, Italy, Spain and Switzerland) and MENA region (Iran, Kuwait, Saudi Arabia, Turkey and UAE) pioneers in soft gelatin capsules

7 contract manufacture - soft gelatine capsules Our Soft Gelatin Capsules Production Services Include: o purchase of ingredients from certified suppliers in compliance to the customer specification. o production of trial batches required for the product development o production in different shapes, colors and sizes o analytical quality control of all incoming materials, o provision of all necessary documentation and certificates required for regulatory authorities o performing Stability tests covering all climatic Zones o comprehensive production/batch records for each production o quality analysis to final product under eugmp/ HACCP (ex assay, microbiological test etc) o flexible lead times from 60 to 90 days. pioneers in soft gelatin capsules

8 contract manufacture - soft gelatine capsules production capabilities &capacities All of our soft gelatin capsules are manufactured in our 3 dedicated lines, operating under EuGMP/ HACCP guidelines. We have the capacity to encapsulate any formulation in our Class D facilities : Rx, OTC, Hormonal, Food Supplements and Cosmetic Formulations. Total capacity: 2.0 billion soft gelatin capsules per year pioneers in soft gelatin capsules

9 contract manufacture - soft gelatin capsules Continuous Expansion Strategic Investment planning entails installing 4 new and additional soft gel capsules production lines until Total capacity is estimated to exceed 5.0 billions caps/ year Timeline: Installment of 1st Line is underway, expected to be fully operational in Q Capacity will then reach 2.6 billions caps/year (calculated as oval 6). pioneers in soft gelatin capsules

10 Pharmaceuticals - GAP brand GAP brand name has been associated with quality, efficacy and reliability. GAP brand is placed in the forefront of the Greek pharmaceutical industry since where patient comes first

11 Pharmaceuticals - international partnerships GAP is third largest generic drug companies in Greece and a leader in the Cardiovascular and Central Nervous System therapeutic drug categories. Large foreign firms have trusted GAP for the promotion of their products in Greece through distribution or Licensing Agreements. GAP with well-organised and dedicated marketing and sales department of over 70 people, can guarantee successful promotion and high returns in the Greek market for any international company. development through innovation

12 Pharmaceuticals - international partnerships development through innovation

13 GAP branded food supplements Our products are harmonious blend of Nature & Science and are marketed under the brand name of EVIOL. EVIOL brand has become synonymous with GAP's growth, gaining the trust of consumers worldwide, promoting an integrated health care and beauty system. science supplements that life requires

14 science supplements that life requires

15 quality control & analytical development Our quality control department consists of 9 highly qualified people and are responsible for the testing of all incoming materials, intermediate and final products. GAP employs completely equipped Microbiology and Chemistry laboratory with state of the art equipment. (HPLC s, Near-IR, FT IR, UV spectrophotometer, gas chromatographer, dissolution & disintegration testers and stability chambers for zones 2, 3, 4a & 4b). Therefore the quality control department ensures the qualitative superiority of GAP products under EuGMP and HACCP guidelines. where the patient comes first

16 Research & Development Our R&D department is constantly working on developing cutting edge formulae on pharmaceutical & nutraceuticals covering all major therapeutic areas and following market trends. Our R&D department consists of 7 highly qualified people with expertise in Drug formulation Organic chemistry Analytical chemistry Biochemistry, and Drug technology where the patient comes first

17 Research & Development what we do Formulation Development Analytical Development Bioequivalent studies In vivo experiments Dossier submission

18 Research & Development formulation development Formulation Development Hydrophilic fills solutions suspensions Hydrophobic fills

19 Research & Development examples in Pharmaceuticals Hormonal Dutasteride 0.5mg Avodart, Novartis Low concentration Drugs Paricalcitol 1mcg, 2mcg, and 4 mcg Zemplar, Abbot Laboratories Hybrids Isotretinoin 40mg Roaccutane 20mg, Roche

20 Research & Development - examples in Pharmaceuticals Novel formulations Tadalafil GAP 20mg, 10mg, 5mg SGC Cialis, Eli Lilly tab Immediate release formulations Ibuprofen 400mg, 200mg Nurofen, Reckitt Diclofenac Potassium 25mg, 12.5mg Voltaren T, Novartis/GSK Gastro-resistant tablets Rabeprazole mg Pariet, Eisai Ltd

21 Research & Development Private Label Supplements Product design The actives and the quantity selection in our Food supplement range is guided by EFSA claims. Product production Wide range of formulation capabilities (suspensions with different materials) and a selection of any capsule shape, colour and size. Choice of gelatin: Bovine, Pork, Fish and Vegetable (Q3 2017) Soft-gelatin capsule coating (enteric, odor masking)

22 Research & Development: examples in Supplements EVIOL MultiVitamin Energy Plus We are experienced and capable of developing complex formulations in soft gelatin capsules combining oils, minerals, vitamins Ingredient Ginseng Panax extract 1 Vitamin B1* (Thiamine) Vitamin B2* (Riboflavin) Vitamin B3* (Niacin) Vitamin B5* (Pantothenic acid) Vitamin B6*(Pyridoxine) Vitamin B12* (Cyanocobalamine) Vitamin C* (Ascorbic acid) Folic acid* Biotin* Choline Magnesium Iron Zinc Manganese Chromium Molybdenum Copper Selenium Iodine L-Carnitine Alpha-lipoic acid Vitamin E* Vitamin D* (Cholecalciferol) Vitamin A* Lutein* Label claim per capsule 50,0 mg 4,3 mg 5,0 mg 24,0 mg 18,0 mg 5,0 mg 20 μg 140,0 mg 300 μg 70 μg 42,0 mg 60,0 mg 14,0 mg 8,0 mg 2,0 mg 60 μg 75 μg 1,0 mg 55 μg 150 μg 20,0 mg 20,0 mg 14,0 mg 5 μg 800 μg 500 μg

23 headquarters and manufacturing site Agislilaou Athens, Greece for more information please contact tel: (+30) ext 218 quality & reliability guaranteed regardless the challenges where the patient comes first