MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
BATCH SIZE: Small, Medium
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)
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Development and medium scale cGMP manufacturing including chromatography.
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), World Health Organization (GMP / HACCP)
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
BATCH SIZE: Small, Medium
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC).
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
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, PARTICLE ENGINEERING
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
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
Apeloa Pharmaceutical Co., Ltd.
Apeloa Pharmaceutical Co., Ltd
Apeloa CDMO provides world-class discovery, development, and manufacturing services for APIs, Intermediates, and RSMs.
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), 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)
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging
AMSbiopharma
AMSbiopharma
We provide analytical services to support the pharmaceutical, biopharmaceutical, and chemical industries at every stage of drug development.
COMPLIANCE: ICH, ISO, World Health Organization (GMP / HACCP)
MARKETS: EMA (EU)
REGION: Europe
USE: Human, Veterinary
SERVICES: Development services, Analytical / QC services
CATEGORY / PRODUCT: SERVICES
Aenova Group - Location Tittmoning, Germany
Aenova
Competence Center conventional solids high volume plant.
MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)
BATCH SIZE: Large, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Aenova Group - Location Sisseln, Switzerland
Aenova
Competence Center complex conventional solids.
REGION: Europe
MARKETS: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USE: Human
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Aenova Group - Location Regensburg, Germany
Aenova
Competence Center high potent solids (oncology) conventional solids - specialty semisolids & liquids.
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), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Aenova Group - Location Münster, Germany
Aenova
Competence Center low-dosed high potent solids (hormones, hormone-like), low-dosed capsules.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU 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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Aenova Group - Location Marburg, Germany
Aenova
Competence Center complex conventional solids and narcotics.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USE: Human
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Aenova Group - Location Latina, Italy
Aenova
Competence Center animal health products and sterile technologies.
MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU 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: FDF / DRUG PRODUCTS
Aenova Group - Location Kirchberg, Switzerland
Aenova
Competence Center Soft gelatin capsules.
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), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones