PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Soluciones CDMO totalmente integradas para Blow-Fill-Seal (BFS), multidosis estériles, multidosis no estériles, sobres, cápsulas y comprimidos.
MARKETS: EMA (EU), FDA (USA)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
USE: Human
BSL (Biological Safety Level): 1
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (S) Sensory organs, (V01) Allergens, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO especializada en la fabricación de medicamentos inyectables estériles para uso clínico y comercial.
BSL (Biological Safety Level): 3, 1, 2
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
CONTROLLED SUBSTANCES: Lowest potential for abuse
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
REGION: North America
Grifols International | Murcia Plant
Grifols International
Sterile manufacturing solutions (small molecules) in flexible bags
MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Grifols International | Barcelona Plant
Grifols International
Sterile manufacturing solutions (small molecules) in flexible bags and vials.
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
REGION: Europe
CATEGORY / PRODUCT: OLIGONUCLEOTIDES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, SERVICES
USE: Human
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ISO, EMA (EU GMP), French Service-Public (CIR), ECOVADIS, World Health Organization (GMP / HACCP), MHRA (UK GMP), NMPA (China GMP), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), ISP (Chile BPM), INVIMA, MSPAS, COFEPRIS, DIGEMID, Health Canada (Canada GMP)
SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Logistics, Quality Assurance services
BATCH SIZE: Small, Large, Medium
MARKETS: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals, (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
CHEMICAL-SYNTHETIC manufacturing site
MAI network supplier
Centro de I+D
Location available after registration
BIOLOGICS manufacturing site
MAI network supplier
Organización de Desarrollo y Fabricación por Contrato (CDMO) con enfoque en proteínas recombinantes y anticuerpos monoclonales (mAbs).
Location available after registration
CHEMICAL-SYNTHETIC manufacturing site
MAI network supplier
Synfine Drugs
Location available after registration