
Adragos Pharma
Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
Markets: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, 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
Use: Human
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), 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)

LABORATORIO REIG JOFRE SA
Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.
Markets: DIGEMID (Peru), ANVISA (Brazil), ISP (Chile), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia), TGA (Australia), INVIMA (Colombia), MHRA (UK)
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS
Compliance: ISP (Chile BPM), Roszdravnadzor (Russia GMP), EMA (EU GMP), DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), SFDA (Saudi Food & Drug Authority), ECOVADIS, INVIMA, Health Canada (Canada GMP)
Controlled Substances: Lowest potential for abuse
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), 1 / low-hazard (PDE > 5,000 µg/day)
BSL (Biological Safety Level): 1
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use

Markets: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (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
Category / Product: FDF / DRUG PRODUCTS
Compliance: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Sidefarma SA
CMO specialized in the manufacture of small and medium size batches for pharmaceutical companies across the world in regulated markets.
Markets: DIGEMID (Peru), Turkish Health Authorities, EDE (UAE), PMDA (Japan), EMA (EU), SFDA (Saudi Arabia), TGA (Australia), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), UAE Ministry of Health & Prevention, ISO
Controlled Substances: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing 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)

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), Rest of World, 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
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

Laboratorios Salvat
Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Compliance: EMA (EU GMP), FDA (cGMP), ISO
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU)
Therapeutic Areas of Expertise (ATC): (V01) Allergens, (S) Sensory organs
BSL (Biological Safety Level): 1
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
MAI network supplier
Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids.
Location available after registration
MAI network supplier
Developer and manufacturer of new drug products with control realease technologies.
Location available after registration
MAI network supplier
Israeli CDMO specialized in the development and GMP manufacturing of complex synthetic drug products and chemistry-based medical devices.
Location available after registration
These facilities match your main criteria but not every optional filter — including other countries in the same region.

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: Turkish Health Authorities, ANVISA (Brazil), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil), TGA (Australia GMP), NMPA (China GMP), ECOVADIS, ISO, Health Canada (Canada GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing 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)
Controlled Substances: High potential for abuse & medical use

Adragos Pharma
Non-sterile semi-solid and liquid pharmaceutical products.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP)
Controlled Substances: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
Markets: PMDA (Japan), EMA (EU), MFDS (South Korea), NMPA (China), 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)

LABORATORIO REIG JOFRE SA
Injectable (lyo and liquid) and Liquid manufacturing facilities.
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS
Compliance: ISP (Chile BPM), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), ECOVADIS, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Region: Europe
BSL (Biological Safety Level): 3, 1, 2
Markets: ANVISA (Brazil), ISP (Chile), PMDA (Japan), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
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), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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