about us Cyndea Pharma independent

Transcription

1 2014

2 02 about us Cyndea Pharma is an independent Spanish laboratory specialized in the development and manufacturing of generic formulations all of which is done in the latest state-of-the-art high containment facilities.

3 03 hormonal contraception endometriosis hormone replacement therapy infertility The main focus of the Company is the manufacturing and development of highly active generic medicines such as hormonal products related to the field of women s health. hormone-dependent cancer treatments Certifications: GMP granted by European Health Authorities I ANVISA I Next steps: FDA

4 04 milestone Cyndea Pharma

5 pharmaceutical development services 05 Cyndea Pharma offers a fully integrated approach to the development of highly active molecules in pharmaceutical solid dosage forms. API highly active bulk drug substance Analytical Development Pre-formulation Formulation development Scale-up & Validation Trial Batches, Clinical trials & Test manufacturing Stability, Dossier compilation & Registration Commercial Manufacturing

6 pharmaceutical development services R&D Personnel: Employees: 60% University Graduates R&D Laboratory capabilities: Equipped with Chromatography Techniques (HPLC, GC) and Conventional Techniques (PSD, DSC, UV, IR, In vitro dissolution...). Stability chambers. High containment isolator for the handling potent drugs. Development and validation of analytical methods. Extensive ICH compliance stability studies. 06 UPLC technologies.

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8 pharmaceutical development services Formulation services: Solid dosage forms. Soft Gelatine Capsules. Pilot plant for highly potent molecules. Specific experience in formulating highly potent molecules. 08

9 Products Products ectd EU Dossiers ectd EU Dossiers Sexual hormones Sexual hormones Prednisone 10 mg products Prednisone 30 mg ANDA US Dossiers Sexual hormones Drospirenone 3 mg + EE 0,03 mg Drospirenone 3 mg + EE 0,03 mg Drospirenone 3 mg + EE 0,03 mg Drospirenone 3 mg + EE 0,02 mg Drospirenone 3 mg + EE 0,02 mg Drospirenone 3 mg + EE 0,02 mg Desogestrel 75 μg Desogestrel 0,150mg + EE 0,02mg + EE0,01mg Desogestrel 75 μg Dienogest 2 mg + EE 0,03 mg Desogestrel 0,150 mg + EE 0,03 mg Dienogest 2 mg + EE 0,03 mg Chlormadinone 2 mg + EE 0,03 mg Levonogestrel 0,1 mg + EE 0,02 mg Chlormadinone 2 mg + EE 0,03 mg Desogestrel 0,150 mg + EE 0,02 mg Norgestimate 0,25 mg + EE 0,35 mg Desogestrel 0,150 mg + EE 0,02 mg Desogestrel 0,150 mg + EE 0,03 mg Desogestrel 0,150 mg + EE 0,03 mg Levonogestrel 0,1 mg + EE 0,02 mg Levonogestrel 0,1 mg + EE 0,02 mg Norgestimate0,25 0,25mg mg++ee EE0,035 0,35 mg Norgestimate mg Norgestimate 0,25 mg + EE 0,35 mg Hormonal products Hormonal products Prednisone 2,5 mg Prednisone 2,5 mg Prednisone 5 mg Prednisone 5 mg Prednisone 10 mg Prednisone 10 mg Prednisone 30 mg Prednisone 30 mg ANDA US Dossiers ANDA US Dossiers Sexual hormones Sexual hormones Drospirenone 3 mg + EE 0,03 mg Cyndea pharma Cyndea pharma 09

10 CONTRACT MANUFACTURING SERVICES Cyndea Pharma

11 Cyndea offers contract manufacturing services for highly active molecules in solid dosage forms. Cyndea can meet your outsourcing needs for both potent & conventional solid dose drugs. Cyndea offers segregated manufacturing premises for highly active molecules, with a state-of-theart GMP facility designed to comply with the most demanding environmental and safety regulations. THE PLANT Two segregated manufacturing areas for oral tablets and one for Soft-Gel Line 1: High potency pharmaceuticals (hormones). Dedicated line. Line 2: Slightly potent molecules (Corticosteroids and others). Line 3: Soft gelatine capsules (hormones) Line 4 (2016): soft gelatine capsule (non hormonal) Packaging areas. 2 blister lines 1 bottle line 2015: multiphasic blister line. Warehouse. Pilot Plant. QC Laboratories. R&D Laboratories. FDA: expecting PAI Q ANVISA approved

12 12 layout Cyndea Pharma

13 DESCRIPTION M2 Administrative area Laboratories 545 Production area & tetsing plant Maintenance building 420 Technical area (HVAC) 400 Warehouse Dispensing/Sampling 160 Total constructed area Total site area

14 14 contract manufacturing services Personnel: 95 (60% highly-qualified) Production capacity: Line1: Hormones line. Line2: Corticosteroids & others line. Line3: Soft gelatine capsules line. Cyndea Pharma

15 Cyndea Pharma turnovers 15

16 16 location we re in46countries Portugal Belgium Albania Kosovo Macedonia Germany Bulgaria Cyprus Czech Republic Slovakia Algeria Finland Greece Israel Guatemala Costa Rica Cuba Uruguay Montenegro Netherlands Hungary Switzerland Serbia Ukraine UK Morocco Tunisia Romania Moldova France New Zeland Malta France Syria Belarus Spain Russia Kazakhstan Mexico Italy Canada South Africa Denmark China Brazil United Arab Emirates

17 Cyndea Pharma, S.L. Polígono Industrial Emiliano Revilla Sanz Avda. de Ágreda, Ólvega (Soria). Spain Phone: Fax: location 17 2h 15 min Madrid 1 h Airports

18 18 location thanks for your attention

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20 MADRID OFFICE: FACTORY: