
Seacross Pharmaceutical Co Ltd
Das Forschungs- und Entwicklungszentrum spielt eine grundlegende Rolle bei der Unterstützung der Entwicklung sowohl von Wirkstoffen als auch von fertigen Darrei
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest der Welt, 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, 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)

Hikal Ltd.
Hikal ist ein führender Pharma-CDMO, der sich auf kleine Moleküle, HPAPIs, Prozessentwicklung, kundenspezifische Synthese und kommerzielle Fertigung spezialisiert hat.
Markets: ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest der Welt, 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
Compliance: Health Canada, EMA (EU GMP), PMDA/MHLW (Japan GMP), PMDA (Japan), World Health Organization (GMP / HACCP), MHRA (UK GMP), ANVISA (Brazil), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP), ICH
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: SERVICES, CHEMICAL-SYNTHETIC
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, Veterinary
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)

CARBOGEN AMCIS
Entwicklung und cGMP-Herstellung im mittleren Maßstab einschließlich Chromatographie.
Batch Size: Small, Medium
Compliance: PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Category / Product: SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)

CARBOGEN AMCIS
Entdecken Sie unsere Kapazitäten zur Herstellung kosmetischer Inhaltsstoffe, Feinchemikalien und kundenspezifischer Synthese von Pharmazwischenprodukten.
Batch Size: Small, Medium, Large
Category / Product: SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
Region: Europe
Services: Analytical / QC services, Manufacturing services, Development services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Compliance: ECOVADIS, ISO, Halal Research Council

Markets: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium
Compliance: PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP)
Category / Product: SERVICES, CHEMICAL-SYNTHETIC
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, 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)

Hikal Ltd.
cGMP-Prozessentwicklung, Scale-up und Herstellung kleiner Molekül-APIs, NMEs und Zwischenprodukte von Gramm bis Tonnen.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest der Welt, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), 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, (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (V06) Nutrients
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Halal Research Council, COFEPRIS
Category / Product: COSMETICS, SERVICES, NUTRACEUTICALS, CHEMICAL-SYNTHETIC
Use: Human, Veterinary
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)
Services: Manufacturing services, Development services

Seacross Pharmaceutical Co Ltd
Als einer von drei Kernstandorten neben dem Forschungs- und Entwicklungszentrum und der Formulierungsanlage spielt unsere API-Produktionsanlage eine wichtige Ro
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest der Welt, 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
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)
Category / Product: CHEMICAL-SYNTHETIC
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