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Spain
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
Spain
Laboratorios Grifols | 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
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (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
Spain
BDI biotech Production Plant
BDI biotech
We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.
MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Regulatory services
REGION: Europe
COMPLIANCE: ISO
BSL (Biological Safety Level): 1
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: BIOLOGICS
Spain
53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
CATEGORY / PRODUCT: BIOLOGICS
United States
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
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), Rest of World
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
USE: Human, Veterinary
CONTROLLED SUBSTANCES: Lowest potential for abuse
OEB (Occupational Exposure Banding): 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)
REGION: North America
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Germany
BAG Health Care
BAG Health Care GmbH
Parenteral F&F provider for vials in small to mid sized batches.
MARKETS: EMA (EU), MHRA (UK), TGA (Australia)
REGION: Europe
USE: Human, Veterinary
BSL (Biological Safety Level): 1
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 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)
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Spain
HIPRA BIOTECH SERVICES | Amer
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, Veterinary
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, FDF / DRUG PRODUCTS
United States
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Commercial API Small Molecules Synthesis.
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, ECOVADIS
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services
OEB (Occupational Exposure Banding): 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)
REGION: North America
United Kingdom
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Commercial API Small Molecules Synthesis.
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
OEB (Occupational Exposure Banding): 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)
China
Pharmaron API Commercial Synthesis Shaoxing (China)
Pharmaron
Commercial API Small Molecules /Peptides Synthesis.
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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: NMPA (China), FDA (USA)
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, NMPA (China GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
Belgium
White Raven - Legiapark
White Raven
Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid 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)
MARKETS: EMA (EU)
REGION: Europe
USE: Human
BSL (Biological Safety Level): 1, 2
SERVICES: Manufacturing services, Packaging
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP)
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
India
Viswa Laboratories Pvt Ltd
Viswa Laboratories Private Limited
CRAMS/CDMO, APIs, Intermediates and specialty chemicals.
MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)
REGION: APAC
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system
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)
COMPLIANCE: World Health Organization (GMP / HACCP)
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