DEVA ÇERKEZKÖY I MANUFACTURING FACILITY
DEVA Holding Çerkezköy I manufacturing facilities, located at a 100 km distance to Istanbul, founded on an area of 52,000 m² in Organized Industrial Zone with closed facilities of 32,000 m², comprise of modern buildings where liquids/semi solids, inhaled products, solid, betalactam 1, betalactam 2 and hormone products are manufactured.
Liquid / Semi Solid Manufacturing Unit
Non-sterile liquid and semi solid products are manufactured in Çerkezköy manufacturing facilities.
All syrups, drops, and sprays are manufactured in the liquid unit, creams and gels are manufactured in pomade unit, and suppository and pessaries are manufactured in the pessary unit.
In the unit, in which a total of 15 million boxes were manufactured in 2014, a total of 19.9 million boxes were manufactured in 2015, 12.3 million of which are syrups, suspensions and drops, and 7.1 million are creams, gels and suppositories.
An increase of 32% was achieved in liquid-semi solid manufacture in 2015.
Çerkezköy I manufacturing facilities, designed for the manufacture of solid forms (tablets, film tablets, capsules, powder suspensions, etc.) have a packaging capacity of 35 million boxes of finished products annually in a single shift.
In this unit, in which 37 million boxes of products were manufactured in 2014, a total of 44.7 million boxes of finished products, 42.8 million boxes of tablets/capsules, and 1.9 million boxes of suspensions were packaged in 2015.
An increase of 21% was achieved in total solid manufacture in 2015.
Inhaled Products Manufacturing Facility
In the facility which was approved by the Ministry of Health in 2014 which has its own ventilation, water system and laboratory in a separate building, 1.2 million boxes were manufactured in 2015, with an increase of 68%, compared with the manufacture of 725 thousand boxes of MDI and DPI in 2014. In the first half of 2016, nebules for inhalation will be manufactured by the state-of-the-art technology. In the first half of 2016, nebules for inhalation will be manufactured by the state-of-the-art technology (BFS).
Çerkezköy Betalactam Manufacturing Facilities, designed for manufacturing drugs in non sterile solid (tablets/film tablets, powder suspensions, capsules) and sterile powder injectable pharmaceutical forms.
Cephalosporin Manufacturing Unit (Betalactam I)
Whereas, in the cephalosporin unit, 22.5 million boxes were manufactured in 2014, a total of 26.9 million boxes of pharmaceutical products were manufactured in 2015; 20.6 million boxes of injectable sterile powder vials, 2 million boxes of oral suspensions, and 4.3 million boxes of coated film tablets, and capsules.
An increase of 19% was achieved in this unit in 2015.
Penicillin Manufacturing Unit (Betalactam II)
Whereas, in the penicillin unit, 14.4 million boxes were manufactured in 2014, a total of 18.6 million boxes of pharmaceutical products were manufactured in 2015; 3.2 million boxes of injectable sterile powder vials, 5.8 million boxes of oral suspensions, and 9.6 million boxes of coated film tablets.
An increase of 29% was achieved in this unit in 2015.
Hormone Products Manufacturing Facility
Approximately 12.4 million boxes of products were manufactured in the hormone products manufacturing unit in 2015; 2.9 million boxes of creams/pomades, 2.2 million boxes of tablets, and 7.2 million boxes of sterile ampoules, vials, and drops.
Our facilities successfully passed the GMP inspections by New Zealand (Medsafe), South Africa (MCC) and RoT Ministry of Health, and Abbott’s customer inspection.
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. The manufacturing activities, which were conducted with 22 products in 8 molecules, were realized with 29 products in 8 molecules in 2015, with the 7 additional products.
The manufacturing quantity, which was 249,792 boxes in 2014, was 219,119 boxes in 2015.
Of the 219,119 boxes manufactured in 2015, 77,686 were capsules, and 141,433 were tablets.
ANDA products for the USA market as well as the registration application products for the EU market are manufactured in this unit, and the US FDA inspections and German MoH inspections for Europe were held for this manufacturing unit.
Solid oncology unit was included in the scope of the inspections conducted by US FDA in August 2015 and German Ministry of Health in December 2015.
In 2015, new products including Midizol 100 mg 5 capsules, Midizol 20 mg 5 capsules, Midizol 250 mg 5 capsules, Midizol 5 mg 5 capsules, Midizol 140 mg 5 capsules, Midizol 180 mg 5 capsules, and Imatis 200 mg 60 film tablets were manufactured. Registration activities for Rivelime 5 mg capsules, Rivelime 10 mg capsules, Rivelime 15 mg capsules, and Rivelime 25 mg capsules are ongoing for 2016.
Sterile Liquid Oncology Manufacturing Unit
Sterile liquid and sterile lyophilized powder forms are manufactured in sterile liquid oncology manufacturing unit. The manufacturing activities, which were conducted with 14 products in 7 molecules, were realized with 15 products in 7 molecules in 2015, with 7 additional products.
The manufacturing quantity of the unit, which was 571,060 boxes in 2014, was 831,591 boxes in 2015, with an increase of 46%.
Of 831,591 boxes, liquid products comprise 427,456 boxes and lyophilized products comprise 404,135 boxes.
In 2016, ANDA products for the US market and registration application products for the European market are going to be manufactured in this unit.
Sterile Animal Health Products Manufacturing Unit
Products in sterile suspension and pomade form are manufactured in Sterile Animal Health Products Manufacturing Unit. The manufacturing quantity of the unit, which was 74,587 boxes in 2014, was 194,302 boxes in 2015, with an increase of 160%.
Of 194,302 boxes, suspensions comprise 190,390 boxes and pomades comprise 3,912 boxes.
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 powder and tablet form are manufactured in non-betalactam subunit, products in powder form are manufactured in betalactams subunit.
At the end of 2014, the opening inspection of the unit was performed by the Ministry of Food, Agriculture and Livestock, and following the successful inspection, manufacturing activities began in 2015. The manufacturing site change operations of seven large-volume powder, two small-volume powder, and five tablet products were completed and these products were manufactured during 2015. Application files of three large-volume powder, one small-volume powder and two tablet products have been submitted and awaiting approval. In Q1 2016, the submission batches of the remaining five products are going to be manufactured and their files are going to be submitted to the Ministry of Food, Agriculture and Livestock. The total number of products manufactured in the unit is 25.
A total of 564,293 boxes of products were manufactured in 2015, 517,921 boxes of which were tablets, and 46,372 boxes of which were in powder form.
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 11,526 kg in 2014, was 14,465 kg in 2015, with an increase of 25%. 13 different APIs are manufactured in accordance with customer requests.
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 new API named Benidipine HCl was manufactured in 2015.
The API manufacturing units successfully passed four different European customers’ inspections in 2015.
To sum up, the manufacturing quantities in DEVA Holding’s Çerkezköy II facilities increased by 100% compared with the previous year. The capacity utilization rate of Çerkezköy Main Manufacturing and API Manufacturing facilities in 2015 were 90%.
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 ampoules, 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 large volume (LVP) and small volume (SVP) parenteral solutions by BFS (Blow-Fill-Seal) technology are manufactured in Kartepe Sterile Liquid Drug Manufacturing Facilities. (sterile liquid solution for infusion in PE bottle, sterile liquid eye drop in PE bottle and sterile liquid diluent vial).
In our facilities, in which 22.3 million boxes of sterile liquid drugs were manufactured in 2014, 37.1 million boxes were manufactured in 2015, with an increase of 66%.
Manufacture of Sterile Ampoules for Injection
In our facility, in which a total of 16 million boxes of ampoules and 19 million diluent ampoules were manufactured in 2014, a total of 27,2 million boxes of ampoules and 31,3 million diluent ampoules were manufactured in 2015. The total number of single ampoules manufactured in 2015 is 135,9 million.
There was a 46% increase in the total number of single ampoules we manufactured in 2015 compared with 2014.
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 5.9 million boxes of vials were manufactured in 2014, 9 million boxes of vials were manufactured in 2015.
Vial manufacture increased by 53% approximately in 2015, compared with 2014.
In this unit, which began its manufacturing activities in 2014, with a total of 310,514 boxes, a total of 719,327 boxes were manufactured in 2015.
In 2015, a significant increase occurred in BFS - SVP manufacture, over two folds of the manufacture in 2014.
On our BFS-LVP production line, on which 87,859 bottles were manufactured in 2014, a total of 136,412 bottles were manufactured in 2015.
Furthermore, our sterile liquid drug manufacturing facilities approved by the Ministry of Health, Ministry of Food, Agriculture and Livestock, and German Ministry of Health (BFS - SVP and BFS - LVP lines) successfully passed the inspections of the Ministry of Health, Ministry of Food, Agriculture and Livestock, FDA (the inspection performed by United States Food and Drug Administration only on sterile liquid vial and sterile liquid lyophilized vial production line), and Gabon Ministry of Health in 2015.
Manufacture of Empty Medical Ampoules
Our empty medical ampoule manufacturing unit meets a substantial part of the market’s need as one of the three leading medical ampoule manufacturing companies in our country.
Our facilities, which holds ISO 9001:2008 certificate, is audited by Bureau Veritas on a periodical basis.
A substantial part of the medical ampoules manufactured in our unit, which has been implementing ISO 9001 quality management system since 2001, is sold to the leading pharmaceutical companies in Turkey other than DEVA Holding.
The number of empty ampoules we manufactured was 134.5 million in 2014, and 156.6 million in 2015.
In our unit, in which Boğaziçi Colognes, one of the best selling cologne brands in Turkey, are manufactured, a wide range of products such as 80° lemon, lavender, and shaving colognes are manufactured.
The number of colognes we manufactured was 2.92 million in 2014, and 3.14 million in 2015.
The capacity utilization rate of our Kartepe manufacturing facilities in 2015 is 86%.
The total human and veterinary products manufactured in our manufacturing facilities on a box basis was 119.8 million boxes in 2012, 123.7 million boxes in 2013, 131 million boxes in 2014, and 168.3 million boxes in 2015.
And the total manufacturing value (drugs and other) was realized as 212.3 million TL in 2012, 226.8 TL in 2013, 260.6 million TL in 2014, and 325.8 million TL in 2015.