Showing 22 facilities
China
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: ISP (Chile), MSPAS (Guatemala), FDA (USA), COFEPRIS (Mexico), DIGEMID (Peru), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, SFDA (Saudi Arabia), ANMAT (Argentina), CDSCO (India), MFDS (South Korea), INVIMA (Colombia), Turkish Health Authorities, EDE (UAE), TGA (Australia), Rest of World
Batch Size: Large, Small, Medium
Compliance: FDA (cGMP), DIGEMID, BRCGS, ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, INVIMA, TGA (Australia GMP), TITCK (Turkish Health Authorities), ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (N) Nervous system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Region: APAC
China
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: Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), TGA (Australia), Rest of World
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO
Region: APAC
Italy
Aenova Group - Location Latina, Italy
Aenova
Competence Center animal health products and sterile technologies.
Markets: ANVISA (Brazil), FDA (USA), EMA (EU), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities, SFDA (Saudi Arabia), TGA (Australia)
Services: Development services, Analytical / QC services, Packaging, Manufacturing services, Quality Assurance services
Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), SFDA (Saudi Food & Drug Authority)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO
Region: Europe
United States
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Rest of World
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: North America
Germany
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 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 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
Belgium
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*.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
BSL (Biological Safety Level): 3, 4, 1, 2
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), MHRA (UK), MFDS (South Korea), TGA (Australia)
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China 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
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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
Category / Product: FDF / DRUG PRODUCTS
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Early Phase Sterile Fill Finish
Location available after registration
Limited view
COSMETICS manufacturing site
MAI network supplier
One-stop CDMO Solutions for APl and Key intermediates.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.
Location available after registration
Suggested Results
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Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
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)
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)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Slovakia
HBM Pharma
Hbm Pharma
EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO
Region: Europe
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