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Apeloa Pharmaceutical Co., Ltd.
Apeloa Pharmaceutical Co., Ltd
Apeloa CDMO ofrece servicios de primer nivel en descubrimiento, desarrollo y fabricación de Ingredientes Farmacéuticos Activos (APIs), Intermedios y Materiales
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
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO
CATEGORY / PRODUCT: SERVICES, CHEMICAL-SYNTHETIC
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging
REGION: APAC
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Instalación comercial de moléculas peque as (RSM/API)
BATCH SIZE: Small, Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (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: EMA (EU GMP), PMDA/MHLW (Japan GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
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
MARKETS: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, 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)
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
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
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
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)
CATEGORY / PRODUCT: SERVICES, CHEMICAL-SYNTHETIC
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), 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 site
MAI network supplier
Centro de I+D
Location available after registration
COSMETICS manufacturing site
MAI network supplier
Sitio de desarrollo y fabricación de sustancias activas de peque as moléculas
Location available after registration
OLIGONUCLEOTIDES manufacturing site
MAI network supplier
Fabricante de principios activos (API) e intermedios con certificaciones internacionales.
Location available after registration
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