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MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
REGION: Europe
BSL (Biological Safety Level): 3, 1, 2
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
SERVICES: Manufacturing services, Regulatory services, Development services
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, OLIGONUCLEOTIDES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (Biological Safety Level): 3, 4, 1, 2
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGION: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Adragos Pharma | Jura
Adragos Pharma
Nos especializamos en la fabricación aséptica de productos farmacéuticos y biofarmacéuticos estériles, liofilizados o líquidos, mediante procesos de llenado y a
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), FDA (cGMP)
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), Health Canada (Canada), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
CONTROLLED SUBSTANCES: High potential for abuse & no medical use
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Cenexi Laboratoires Thissen
Cenexi
This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
BSL (Biological Safety Level): 3, 4, 1, 2
MARKETS: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Seda Pharma Development Services
Seda Pharma Development Services Ltd
Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, CHEMICAL-SYNTHETIC
REGION: Europe
USE: Human
COMPLIANCE: MHRA (UK GMP), ECOVADIS
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (Biological Safety Level): 3, 4, 1, 2
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGION: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse
BSL (Biological Safety Level): 3, 1, 2
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
REGION: North America
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Green Phoenix Labs GmbH
Green Phoenix Labs GmbH
Cell Therapy company with excess Cleanroom capacity
BATCH SIZE: Small, Medium
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
SERVICES: Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1
MARKETS: EMA (EU)
Cenexi
Cenexi
GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
MARKETS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
CONTROLLED SUBSTANCES: High potential for abuse & no medical use
THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Aenova Group - Location Latina, Italy
Aenova
Centro de Competencia de productos zoosanitarios y tecnologías estériles.
MARKETS: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities)
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents, (P) Antiparasitic products, insecticides and repellents
BATCH SIZE: Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
MARKETS: EMA (EU)
BAG Health Care
BAG Health Care GmbH
Proveedor de servicios de llenado y acabado (F&F) para viales en lotes pequeños y medianos.
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
MARKETS: EMA (EU), TGA (Australia), MHRA (UK)
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