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Viswa Laboratories Pvt Ltd
Índia

Viswa Laboratories Pvt Ltd

Viswa Laboratories Private Limited

CRAMS/CDMO, APIs, intermediários e especialidades químicas.

MERCADOS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

REGIÃO: APAC

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

BSL (Nível de Segurança Biológica): 1, 2

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

SERVIÇOS: Development services, Manufacturing services

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system

SUBSTÂNCIAS CONTROLADAS: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CONFORMIDADE: World Health Organization (GMP / HACCP)

Pharmaron API Commercial Synthesis Shaoxing (China)
China

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

Síntese comercial de pequenas moléculas/peptídeos de API.

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (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 (Faixas de Exposição Ocupacional): 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)

MERCADOS: NMPA (China), FDA (USA)

REGIÃO: APAC

CONFORMIDADE: FDA (cGMP), ISO, NMPA (China GMP)

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

Pharmaron API Commercial Synthesis Cramlington (UK)
Reino Unido

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Síntese comercial de pequenas moléculas de API.

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

SUBSTÂNCIAS CONTROLADAS: 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

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

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

OEB (Faixas de Exposição Ocupacional): 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)

Pharmaron API Commercial Synthesis Coventry (US)
Estados Unidos

Pharmaron API Commercial Synthesis Coventry (US)

Pharmaron

Síntese comercial de pequenas moléculas de API.

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

SUBSTÂNCIAS CONTROLADAS: 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

MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)

CONFORMIDADE: FDA (cGMP), ISO, ECOVADIS

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

SERVIÇOS: Development services, Manufacturing services

OEB (Faixas de Exposição Ocupacional): 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)

REGIÃO: América do Norte

Indena Settala
Itália

Indena Settala

Indena

Instalação em conformidade com GMP e inspecionada pela FDA, especializada em APIs complexos e compostos de alta potência até OEB 6.

MERCADOS: TGA (Australia), Rest of World, 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)

TAMANHO DO LOTE: Small, Medium, Large

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

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

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

REGIÃO: Europa

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

Hikal Ltd | Bangalore, India
Índia

Hikal Ltd | Bangalore, India

Hikal Ltd.

Desenvolvimento de processos cGMP, aumento de escala e fabricação de APIs de pequenas moléculas, NMEs e intermediários de gramas a toneladas.

OEB (Faixas de Exposição Ocupacional): 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)

MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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), Rest of World

REGIÃO: APAC

CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, ECOVADIS, TGA (Australia GMP), EMA (EU GMP)

TAMANHO DO LOTE: Large, Small, Medium

CATEGORIA / PRODUTO: COSMÉTICOS, NUTRACÊUTICOS, QUÍMICO-SINTÉTICO, SERVIÇOS

USAR: Human, Veterinary

SERVIÇOS: Development services, Manufacturing services

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients

CARBOGEN AMCIS | Neuland
Suíça

CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS

Desenvolvimento e fabricação em média escala.

MERCADOS: 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)

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

TAMANHO DO LOTE: Small, Medium

OEB (Faixas de Exposição Ocupacional): 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 | Manchester, UK
Reino Unido

CARBOGEN AMCIS | Manchester, UK

CARBOGEN AMCIS

Descubra nossos recursos de fabricação de ingredientes cosméticos, química fina e síntese personalizada de intermediários farmacêuticos.

REGIÃO: Europa

CONFORMIDADE: ISO, Halal Research Council, ECOVADIS

TAMANHO DO LOTE: Large, Small, Medium

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS, ENGENHARIA DE PARTÍCULAS

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Aarau
Suíça

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

Desenvolvimento e fabricação de cGMP em média escala, incluindo cromatografia.

MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, BIOLÓGICA, SERVIÇOS, ENGENHARIA DE PARTÍCULAS

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

TAMANHO DO LOTE: Small, Medium

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

Seacross Pharmaceutical Co Ltd

Como um dos três locais principais, juntamente com o centro de P&D e a fábrica de formulação, nossa unidade de fabricação de API desempenha um papel vital na ca

SUBSTÂNCIAS CONTROLADAS: 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

MERCADOS: 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), Rest of World

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

REGIÃO: APAC

CONFORMIDADE: 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

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

BSL (Nível de Segurança Biológica): 1, 2, 3, 4

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (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 (Faixas de Exposição Ocupacional): 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), 5 / HPAPI (PDE < 10 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

O Centro de P&D desempenha um papel fundamental no apoio ao desenvolvimento tanto de APIs quanto de formas farmacêuticas acabadas.

CONFORMIDADE: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, 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)

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS, QUÍMICO-SINTÉTICO

OEB (Faixas de Exposição Ocupacional): 1 / low-hazard (PDE > 10,000 µg/day), 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)

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (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

BSL (Nível de Segurança Biológica): 3, 4, 1, 2

SUBSTÂNCIAS CONTROLADAS: 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

MERCADOS: 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), Rest of World

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

REGIÃO: APAC

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

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