ابحث واعثر على CMO / CDMO الذي تحتاجه

Use: Human

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), NMPA (China GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

Services: Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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

Batch Size: Small, Medium

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: Europe

Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), TGA (Australia)

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

Use: Human, Veterinary

Batch Size: Large, Small, Medium

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse

Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

Category / Product: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Region: Europe

Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU GMP)

Use: Human

Batch Size: Large

Services: Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & medical use, Low potential for abuse

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, SERVICES

Region: APAC

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, SERVICES

Region: Europe

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), بقية العالم

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

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 - 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, High potential for abuse & no medical use, 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), بقية العالم

Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

Region: APAC

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

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

Category / Product: CHEMICAL-SYNTHETIC

Therapeutic Areas of Expertise (ATC): (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, (V04) Diagnostic agents

OEB (Occupational Exposure Banding): 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), 5 / HPAPI (PDE < 10 µg/day)

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

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

BSL (Biological Safety Level): 3, 4

Controlled Substances: High potential for abuse & medical use

Compliance: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)

Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities

Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

Region: Europe

Batch Size: Large, Small, Medium

Use: Human

Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents

Category / Product: FDF / DRUG PRODUCTS