A plant engaged in the development and manufacturing of steroid-based generic medicines, women’s health and cancer treatments in tablet and soft gelatin capsule forms. It operates as Contractual Manufacturing Organization (CMO) for strategic partners.
Size
10,236 m²
Team
276 professionals
Formulation capabilities
- Oral solid dosage forms:
- Soft gelatin capsules (SGC)
- Tablets
- Development and validation of analytics
- Manufacturing and packaging of batches for clinical trials
- Stability studies
- Technology transfers
- Capacity and specialisation to manufacture small-scale batches
Technologies
- Wet granulation
- Dry granulation (mixing)
- Compression
- Coating
- SGC API reactor
- Gelatin reactor
- SGC encapsulation
- Drying
- Inspection
- Laser printing
- Packaging
Installations at the Cyndea Pharma plant
Depot
This contains the raw materials, packaging materials, semi-manufactured products and finished products.
Dispensing Area
Weighing and preparation of the materials needed to manufacture a batch.
Line 1
Manufacturing of sexual hormone tablets.
Line 2
Manufacturing of non-sexual hormone tablets.
Line 3
Manufacturing of sexual hormone soft gelatin capsules (SGC).
Line 4
Manufacturing of non-sexual hormone soft gelatin capsules (SGC).
Line 5
Manufacturing of soft gelatin capsules (SGC) for small batches.
Intermediate Storage Area (IA)
Storage of primary and semi-manufactured materials.
Conditioning Area
Line 1, 3, 3, 4 and 5.
Facilities
Storage of primary and semi-finished material.
Offices and laboratory
Our standards of quality
Cyndea Pharma meets the quality standards required by each country with which it maintains commercial ties.
- Albania AMPMD (The Agency for Medicinal Products and Medical Devices)
- Angola ARMED (The Ministry’s National Regulatory Agency for Medicines and Health Technologies)
- Argentina ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
- Australia TGA (Therapeutic Goods Administration)
- Austria AGES (Austrian Agency for Health and Food Safety)
- Azerbaijan Center of drug analytical expertise of the Ministry of health of Azerbaijan
- Bahrain NHRA (National Healt Regulatory Authority)
- Belarus Ministry of Health of the Republic of Belarus
- Belgium FAMHP (The Federal Agency for Medicines and Health Products)
- Bosnia and Herzegovina ALMBIH (The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina)
- Brazil ANVISA (Agência Nacional de Vigilância Sanitária)
- Bulgaria BDA (Bulgarian Drug Agency)
- Canada Health Canada
- Chile ANAMED (Agencia Nacional de Medicamentos)
- China NMPA (National Medical Products Administration)
- Colombia INVIMA (The National Food and Drug Surveillance Institute)
- Croatia HALMED (Agency for medicinal products and medical devices of Croatia)
- Cyprus Ministry of Health – Pharmaceutical Services
- Czechia SUKL (State Institute for Drug Control)
- Denmark Laegemiddelstyrelsen (Danish Medicines Agency)
- Dominican Republic DIGEMAPS (Direccion General de Medicamentos, Alimentos y Productos Sanitarios)
- Ecuador ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)
- Ethiopia EFDA (Ethiopian Food and Drug Administration)
- Finland FIMEA (Finnish Medicines Agency)
- France ANSM (National Agency for the Safety of Medicine and Health Products)
- Germany Federal Institute for Drugs and Medical Devices
- Great Britain MHRA (The Medicines and Healthcare products Regulatory Agency )
- Greece National Organization for Medicines
- Hungary Hungarian National Institue of Pharmacy and Nutrition (OGYÉI)
- Iceland Lyfjastofnun (Icelandic Medicines Agency)
- Iraq The Directorate of Technical Affairs
- Ireland HPRA (Health Products Regulatory Authority )
- Israel Pharmaceutical Division – Ministry of Health
- Italy AIFA (Italian Medicines Agency)
- Jordan JFDA (Jordan Food and Drug Administration)
- Kazakhstan Ministry of Healthcare of the Republic of Kazakhstan
- Kuwait MoH (Ministry of Health)
- Kyrgyzstan The Ministry of Health of the Kyrgyz Republic
- Latvia State Agency of Medicines
- Lebanon MOPH (Ministry of Public Health)
- Lithuania SMCA (The State Medicines Control Agency)
- Luxemburg Ministry of Health
- Malaysia NPRA (National Pharmaceutical Regulatory Agency)
- Malta MMA (Malta Medicines Authority)
- Mexico COFEPRIS (Comisión Federal para la protección contra Riesgos Sanitarios)
- Moldova AMDM (The Medicines and Medical Devices Agency )
- Mongolia Medicines Division of the Ministry of Health
- Montenegro CInMED (The Institute for Medicines and Medical Devices)
- Morocco The Department of Pharmacy of Ministry of Health
- Myanmar Food and Drug Administration, Myanmar
- Namibia NMRC (The Namibia Medicines Regulatory Council )
- Netherlands Medicines Evaluation Board
- New Zealand Medsafe
- Norway Norwegian Medical Products Agency
- Oman MoH (Ministry of Health)
- Pakistan DRAP (The Drug Regulatory Authority of Pakistan)
- Palestine The General Directorate of Pharmacy
- Panama Dirección Nacional de Farmacia y Drogas
- Peru DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
- Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Portugal Infarmed (National Authority of Medicines and Health Products)
- Qatar MOPH (Ministry of Public Health in Qatar)
- Republic of North Macedonia MALMED (Macedonian Agency for medicines and medical devices)
- Romania National Authority of Medicines and Medical Devices of Romania
- Russia Minzdrav (The Ministry of Health)
- Saudi Arabia Saudi Food and Drug Authority
- Serbia ALIMS (The Medicines and Medical Devices Agency of Serbia)
- Singapore HSA (The Health Sciences Authority)
- Slovakia SUKL (State Institute for Drug Control)
- Slovenia JAZMP ( Agency for Medicinal Products and Medical Devices of the Republic of Slovenia)
- South Africa SAHPRA (The South African Health Products Regulatory Authority)
- Spain AEMPS (Spanish Agency Of Medicines And Medical Devices)
- Sweeden Lakemedelsverket (Swedish Medical Products Agency)
- Switzerland Swissmedic
- Syrian Arab Republic Directorate of Drug Control
- Taiwan TFDA (Taiwan Food and Drug Administration)
- Thailand FDA THAI (Food and Drug Administration, Thailand)
- The Republic of Korea MFDS (The Korean Ministry of Food and Drug Safety)
- Turkmenistan The Center for Registration and State Quality Control of Medicinal Products (Ministry of Health and Medical Industry)
- Ukraine SMDC (State Service of Ukraine on Medicines and Drugs Control)
- United Arab Emirates EDE (The Emirates Drug Establishment)
- United States of America FDA (The Food and Drug Administration )
- Uzbekistan Center for Pharmaceutical Products Safety (Ministry of Health)
- Venezuela INHRR (Instituto Nacional de Higiene Rafael Rangel)
- Vietnam DAV (The Drug Administration of Vietnam)
Join Cyndea Pharma
To contact the Human Resources area of Cyndea Pharma, please click the link below and provide the necessary information.
