DEVA ÇERKEZKÖY I MANUFACTURING FACILITY

 

DEVA Holding Çerkezköy I manufacturing facilities, located at a 100 km distance to Istanbul, is founded on an area of 52,000 m2 in Çerkezköy Organized Industrial Zone with closed facilities of 32,000 m2.

The facility comprises of modern buildings where liquids/semi solids, cephalosporin, penicillin, hormone-containing products, inhaled products, sterile liquid ampoules and vials, and soft gel capsules are manufactured.

In the production facility, a total of 126 million units were manufactured in 2016 compared to 128 million units in 2017.

            

Liquid / Semi Solid Manufacturing Unit

In the liquid and semi-solid area, syrup-drop and spray, creams and gels, suppository- and pessary-form products are manufactured using the state-of-art technology.

In the unit, in which a total of 24.1 million units were manufactured in 2016, a total of 21.3 million units were manufactured in 2017, 16 million of which are syrup, suspensions and drops, and 5.3 million are creams, gels and suppositories.

             

In the solids unit, tablets and film coated tablets, capsules and powder suspensions-form drugs are manufactured using the state-of-art technology.

In this part, in which 48.1 million units products were manufactured in 2016, a total of 45.3 million units of finished products, of which 43.4 million units were tablets/capsules, and 1.9 million units were suspensions, were packaged in 2017.

                 

Cephalosporin Manufacturing Unit (Betalactam I)

Whereas, in the cephalosporin unit, 24.5 million units were manufactured in 2016, a total of 27 million units of pharmaceutical products were manufactured in 2017; 22.2 million units of injectable sterile powder vials, 1.8 million units of oral suspensions, and 3 million units of film-coated tablets and capsules.

An increase of 10.2% was achieved in total cephalosporin manufacture in 2017.

                               

Penicillin Manufacturing Unit (Betalactam II)

Whereas, in the penicillin unit, 16.3 million units were manufactured in 2016, a total of 16.3 million units of pharmaceutical products were manufactured in 2017; 5,7 million units of injectable sterile powder vials, 4.2 million units of oral suspensions, and 6.4 million units of film-coated tablets.

                  

Hormone Products Manufacturing Unit

Whereas, in the hormone products unit, 12 million units of products were manufactured in 2016; approximately 15,5 million units or product were manufactured in 2017; 2 million units of creams/pomades, 2 million units of tablets, and 11 million units of sterile ampoules, vials, and drops.

An increase of 29% was achieved in total hormone products manufacture in 2017.

           

Inhaled Products Manufacturing Unit

Approved by the Ministry of Health in 2014, the facility has its own ventilation, water system and laboratory in a separate building. 1.35 million units of MDI and DPI were manufactured in 2016 compared with 2.2 million units in 2017, with an increase of approximately 63%.

              

Sterile Liquid Vial and Soft Gel Capsule Products Manufacturing Unit

In the Sterile Liquid Vial Unit, 3.65 million solvent vials and 643 thousand sterile liquid vials were manufactured in 2017. Product registration work in the soft gel capsule unit is underway.

Çerkezköy-1 Manufacturing successfully underwent inspections in 2017 by the Turkish Ministry of Health, and by Bulgarian, Iraqi and Kenyan healthcare authorities as well as customer inspections by the international companies of Abbott, Merck, Boehringer Ingelheim.

 

 

DEVA ÇERKEZKÖY II MANUFACTURING FACILITY

 

DEVA Holding Çerkezköy II manufacturing facilities located at the 110 km distance to Istanbul, founded on an area of 67,551 m2 in Çerkezköy Organized Industrial Zone, with closed facilities of 18,742 m2, comprise of state-of-the-art manufacturing buildings where solid oncology, sterile liquid oncology, animal health products and APIs are manufactured.

Solid Oncology Manufacturing Unit

Products in tablet and capsule form are manufactured in the solid oncology manufacturing unit. In 2017, Tamoxifen 10 and 20 mg launched for the Turkish market as well as Temozolomide capsule US product launched for the US market were realized in 6 different forms, i.e. 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.

The manufacturing quantity, which was 335,393 units in 2016, was 482,824 units with a 44% increase in 2017. 

             

Of the total of 482,824 units of products manufactured in 2017, 146,194 units were capsules and 366,630 units were tablets.

In addition, of the 336,630 units of product manufactured in tablet form, 16,856 units were manufactured for the European market, and of the 146,194 capsules, 50,952 were manufactured for the US-American market.

           

Sterile Liquid Oncology Manufacturing Unit

Products in sterile liquid and sterile lyophilized powder forms are manufactured in Sterile Liquid Oncology Manufacturing Unit.

The manufacturing quantity of the unit of 616,326 units in 2016 was 569,855 units in 2017.

         

             

Of the 569,855 units of products, liquid products comprise 343,444 units and lyophilized products comprise 226,411 units.

Sterile Animal Health Products Manufacturing Unit

Products in sterile suspension and intramammary pomade form are manufactured in Sterile Animal Health Products Manufacturing Unit. The manufacturing quantity of the unit, which was 233,795 units in 2016 was 177,380 units in 2017.

       

              

Of the 177,384 units of product, suspensions comprise 175,325 units and sterile intramammary pomade products comprise 2,059 units. Manufacture of the new products, Vetimisin suspension for injection 50 ml, 100 ml and 250 ml was started in 2017.

Non-Sterile (Solid) Animal Health Products Manufacturing Unit

7 tablet-form products, 15 small powder fill-form products and 1 bag powder fill-form product are being produced in the Non-Sterile Animal Health Products Manufacturing Unit.

Non-Sterile Animal Health Products Manufacturing Unit is divided into two subunits; non-betalactams and betalactams.  While animal health products in tablet, powder and pouch form are manufactured in non-betalactam subunit, products in powder form are manufactured in betalactams subunit.

The production output of the unit was 2,580,658 units in 2016 and 1,731,356 units in 2017. Of these products, 1,278,013 units were tablets, and 453,343 units were powders.

          

                       

API Manufacturing Units

The facilities have four separate designated API manufacturing units: Non-betalactam API, Betalactam Non-sterile API, Betalactam Sterile API, and Oncolytic API.

The API manufacturing quantity, which was 14,257 kg in 2016, was 5,977 in 2017. Manufacturing operations are in accordance with customer requests. Twenty different API products can be manufactured in non-betalactam, betalactam and oncology fields.

From the 5,977 kg product, 814 kg Non-Betalactam products, 4,835 kg Betalactam products and 328 kg Oncology products were manufactured.

          

                    

 

Validation manufacturing for the new products, 2-methyl-2-phenoxy-propionate sodium, Ricobendazole HCl in the Non-betalactam unit and Lenalidomide and Pomalidomide in the oncolytic units were performed in 2017.

In API manufacturing, the toxic gases arising from reaction are neutralized before being released to the atmosphere to minimize the environmental effects resulting from manufacturing activities.

The API manufacturing units successfully passed 3 different European customers’ inspections in 2017.

The capacity utilization rate of Çerkezköy Main and API Manufacturing facilities is 74%.

 

DEVA KARTEPE MANUFACTURING FACILITY

 

 

Deva Holding Kartepe Manufacturing Facilities, located on İzmit - Ankara highway, in Kocaeli Kartepe district, founded on an area of 32,000 m2, with a closed area of 16,500 m2, comprise of state-of-the-art buildings where sterile liquid drugs, empty medical vials, and colognes are manufactured.

Sterile Liquid Drug Manufacturing Unit

Sterile Liquid Ampoules for Injection, Sterile Liquid Vials for Injection, Sterile Liquid Lyophilized Vials for Injection, and Sterile Liquid Solution for Infusion in PE bottle, Sterile Liquid Eye Drop in PE bottle and Sterile Liquid Diluent Vial solutions by BFS (Blow-Fill-Seal) technology can be manufactured in Kartepe Sterile Liquid Drug Manufacturing Facilities. 

In our facilities, in which 48 million units were manufactured in 2016, a total of 52,5 mission units were manufactured in 2017, corresponding to approximately 9,37% increase in production.

         

 

Manufacture of Sterile Vials for Injection

In our facility, in which a total of 33,3 million units of vials and 31,35 million solvent vials were manufactured in 2016, a total of 38,18 million units of vials and 32,22 million solvent vials were manufactured in 2017. The total number of single vials we manufactured in 2017 is 181 million.

There was a 25% increase in the total number of single vial we manufactured in 2017 compared with 2016.

       

           

Manufacture of Sterile Liquid Vials for Injection and Sterile Liquid Lyophilized Vials for Injection

On our production line for Sterile Liquid Vials for Injection and Sterile Liquid Lyophilized Vials for Injection, on which a total of 10.6 million units of vials were manufactured in 2016, 12 million units of vials were manufactured in 2017. 

Vial manufacture increased by approximately 13,60% in 2017, compared with 2016.

       

BFS-SVP Manufacture

On the BfS-SVP production line on which a total of 1,34 million units of production was achieved in 2016, the same amount, i.e. 1,33 million units in total were produced in 2017.

 

                 

BFS-LVP Manufacture

On our BFS-LVP production line, on which a total of 2,8 million bottles were manufactured in 2016, a total of 979,172 bottles were manufactured in 2017. Also, the BFS-LVP line was decommissioned in 2017, and the current area was allocated as a reserve area for potential new investments in the future. 

Furthermore, our facility, which was approved by the Ministry of Health, Ministry of Food, Agriculture and Livestock, and German Ministry of Health for (BFS - SVP and BFS - LVP lines) and by US FDA (the inspection performed by United States Food and Drug Administration only on sterile liquid vial and sterile liquid lyophilized vial production line) was inspected in 2017 also by the Ministry of Health, and Iraqi and Kenyan Health Authorities, and successfully passed these inspections.

 

                   

Manufacture of Empty Medical Vials

Our empty medical vial manufacturing unit meets a substantial part of the market’s need as one of the three leading medical vial manufacturing companies in our country.

Our facilities, which holds ISO 9001:2008 certificate, is audited by Thuringen on a periodical basis.

In our unit, which has been implementing ISO 9001 quality management system since 2001, production was maintained during 2017 with a total of nine production lines, two of which was put in operation during the last few years.

The number of empty vials we manufactured was 175,9 million in 2016, and 235,1 million in 2017.

               

Manufacture of Cologne:

In the unit where Bogazici Colognes, one of the bestselling brands in Turkey, are manufactured, products appealing to different sections of society such as 80º lemon cologne and lavender are being produced

Our production numbers for colognes was 3,55 million in 2016 and 3,6 million in 2017.

In Kartepe manufacturing facility, year 2017 rate of capacity utilization was 82%.

             

PRODUCTION INDICATORS

The total human and veterinary products manufactured in our manufacturing facilities on a unit basis was 131.0 million units in 2014, 168.3 million units in 2015, 176.8 million units in 2016, and 184.7 million units in 2017.

And the total manufacturing value (drugs and other) was realized as 260.6 million TL in 2014, 325.8 million TL in 2015, 359.6 million TL in 2016, and 401.1 million TL in 2017.