Search and Find the CMO / CDMO You Need
Discover highly skilled partners for your drug development and manufacturing project.
ITA
Indena Settala
Indena
Nuestra instalación totalmente conforme con GMP y aprobada por la FDA, ubicada en Settala (a 20 minutos de Milán), está especializada en APIs complejos y compue
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
IND
Hikal Ltd | Bangalore, India
Hikal Ltd.
Desarrollo de procesos cGMP, escalado y fabricación de APIs de moléculas pequeñas, nuevas entidades moleculares (NMEs) e intermedios, desde gramos hasta kilogra
COMPLIANCE: ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, ECOVADIS, TGA (Australia GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
MARKETS: ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), TGA (Australia)
REGION: APAC
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, SERVICES
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Regulatory 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
ESP
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacidades internas de principio a fin, desde el desarrollo de líneas celulares hasta la fabricación comercial.
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
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
ESP
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacidades internas integrales, desde el desarrollo de líneas celulares hasta la fabricación comercial
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
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
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
ESP
CZ Vaccines | Large Scale Plant Spain
CZ Vaccines
Instalación Comercial de Escala Comercial de Uso Único
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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, PARTICLE ENGINEERING
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
ESP
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Instalación de Ensayos Clínicos
MARKETS: EMA (EU), ANVISA (Brazil), CDSCO (India)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS
USE: Human
BSL (Biological Safety Level): 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
BATCH SIZE: Small
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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (R) Respiratory system, (G) Genito urinary system and sex hormones
DEU
Cellex Cell Professionals
Cellex Cell Professionals
Planta de fabricación de terapias celulares (CGT CDMO) y centro de recogida de materiales de partida
MARKETS: EMA (EU), FDA (USA)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (B) Blood and blood forming organs
CHE
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Desarrollo y fabricación cGMP de API de gran potencia, incluidos conjugados anticuerpo-fármaco (ADC)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, CHEMICAL-SYNTHETIC
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
REGION: Europe
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
CHE
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Desarrollo personalizado y producción aséptica automatizada de medicamentos líquidos y liofilizados
MARKETS: TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
COMPLIANCE: French Service-Public (CIR), 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), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
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
REGION: Europe
USE: Human
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
CHE
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Fabricación a gran escala de colesterol, vitamina D y análogos.
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), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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), SQF (Safe Quality Food), NSF
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, COSMETICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1
BATCH SIZE: Small
CHE
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Desarrollo de principios activos muy potentes y producción a peque a escala según las normas cGMP, incluidas la cromatografía y la liofilización
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BATCH SIZE: Small
Suggested Results
These facilities match your main criteria but not all optional filters.
DEU
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.
BATCH SIZE: Small, Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), FDA (cGMP)
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
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Development 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)
MARKETS: FDA (USA), EMA (EU)
BSL (Biological Safety Level): 1
ITA
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci
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), 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, CHEMICAL-SYNTHETIC
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), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)
REGION: Europe, North America
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)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals
ITA
Adare Pharma | EU
Adare Pharma Solutions
Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.
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), 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, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
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), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), 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
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)
GBR
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
CHN
Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.
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
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
CATEGORY / PRODUCT: OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
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)
CHN
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)