Planta dedicada al desarrollo y fabricación de medicamentos genéricos de origen esteroideo, salud de la mujer y tratamientos oncológicos, en comprimidos y cápsulas de gelatina blanda. Actúa como Contractual Manufacturing Organization (CMO) para partners estratégicos.
Superficie
10,236 m²
Equipo
276 profesionales
Capacidades de formulación
- Formulación galénica de sólidos orales:
- Cápsulas de Gelatina Blanda (CGB)
- Comprimidos
- Desarrollo y validación de analíticas
- Fabricación y envasado de lotes para ensayos clínicos
- Estudios de estabilidad
- Transferencias de tecnología
- Capacidad y especialización para fabricar lotes a pequeña escala
Tecnologías
- Granulación húmeda
- Encapsulado CGB
- Granulación seca (mezclado)
- Secado
- Compresión
- Inspección
- Recubrimiento
- Impresión láser
- Reactor API CGB
- Acondicionado
- Reactor gelatina
Instalaciones planta Cyndea Pharma
Almacén
Contiene las materias primas, materiales de envasado, productos semielaborados y producto terminado.
Área de Dispensado
Pesada y preparación de materiales necesarios para la fabricación de un lote.
Línea 1
Fabricación de comprimidos de hormonas sexuales.
Línea 2
Fabricación de comprimidos de hormonas no sexuales.
Línea 3
Fabricación de cápsulas gelatina blanda (CGB) de hormonas sexuales.
Línea 4
Fabricación de cápsulas gelatina blanda (CGB) de hormonas no sexuales.
Línea 5
Fabricación de cápsulas gelatina blanda (CGB) de lotes pequeños.
Área de Almacenamiento Intermedio (IA)
Almacenamiento de material primario y semielaborado.
Área de Acondicionado
Línea 1, 3, 3, 4 y 5
Instalaciones
Mantenimiento y servicios auxiliares.
Oficinas y laboratorio
Nuestros estándares de calidad
Cyndea Pharma cumple con la calidad exigida en cada país con los que mantiene relaciones comerciales.
- 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)
Trabaja en Cyndea Pharma
Para contactar con el área de Recursos Humanos de Cyndea Pharma, por favor, accede al siguiente enlace y cumplimenta la información necesaria
