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Laboratorios Grifols | 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
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (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): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
EVER Pharma Jena GmbH
EVER Neuro Pharma GmbH
Specialized CDMO for development and production of small molecules injectables.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
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), Rest of World
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
ALPHAVET Zrt.- Bábolna Manufacturing Plant
Alphavet Zrt.
The plant is EU GMP certified and produces veterinary medicinal products for 18 EU Member States and 7 other European coutries outside the EU.
MARKETS: EMA (EU)
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP)
BATCH SIZE: Large, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USE: Veterinary
SERVICES: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Avara Pharmaceutical Services | Arecibo Site
AVARA
Commercial-scale oral solid dosage (OSD) manufacturing facility with strong expertise in controlled substances (DEA II V).
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
BATCH SIZE: Large, Medium
USE: Human
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGION: North America
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Avara Pharmaceutical Services | Norman Site
AVARA
Contract manufacturing facility specialized in Oral Solid Dosage (OSD) for clinical and commercial supply.
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
BATCH SIZE: Large, Small, Medium
USE: Human
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGION: North America
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Sidefarma
Sidefarma SA
CMO specialized in the manufacture of small and medium size batches for pharmaceutical companies across the world in regulated markets.
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MARKETS: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
REGION: Europe
COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (EU GMP)
USE: Human
SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
BATCH SIZE: Small, Medium
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Indena Settala
Indena
GMP-compliant and FDA-inspected facility that specializes in complex APIs and high-potent compounds up to OEB 6.
MARKETS: TGA (Australia), Rest of World, 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)
BATCH SIZE: Small, Medium, Large
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
COMPLIANCE: NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
Hikal Ltd | Bangalore, India
Hikal Ltd.
cGMP Process Development, Scale-up and Manufacturing of Small Molecule APIs, NMEs and Intermediates from grams to tones.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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), Rest of World
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, ECOVADIS, TGA (Australia GMP), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: BIOLOGICS
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), MFDS (South Korea), EDE (UAE), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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
USE: Human
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
MARKETS: EMA (EU)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
MARKETS: EMA (EU)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
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