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Serviços chilenos de conformidade e fabricação de BPM

Seus CDMOs chilenos confiáveis em conformidade com os padrões BPM do ISP

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Espanha

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Desenvolvimento e fabricação de antibióticos betalactâmicos (FDF) de última geração.

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Batch Size: Large, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Compliance: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), World Health Organization (GMP / HACCP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP)

Markets: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, SFDA (Saudi Arabia), INVIMA (Colombia), TGA (Australia)

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

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use

Controlled Substances: Lowest potential for abuse

Category / Product: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

China

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

Seacross Pharmaceutical Co Ltd

O Centro de Fabricação de Formulações é dedicado ao desenvolvimento e produção de formas farmacêuticas complexas e de alto valor.

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Batch Size: Large, Small, Medium

Use: Human

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

Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food)

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto do mundo

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

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (D) Dermatologicals, (J) Antiinfectives for systemic use, (B) Blood and blood forming organs, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (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

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: SERVICES, FDF / DRUG PRODUCTS

Region: APAC

Espanha

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.

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

Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BSL (Biological Safety Level): 1, 2

Use: Human

Batch Size: Large, Small, Medium

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)

Region: Europe

Category / Product: BIOLOGICS

Espanha

FAES FARMA | DERIO facility

FAES FARMA

Desenvolvedor e fabricante de medicamentos humanos.

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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), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), EDE (UAE), TGA (Australia)

Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), 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)

Use: Human

Batch Size: Large, Small, Medium

Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (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

Espanha

Laboratorios Grifols | Murcia Plant

Grifols International

Soluções de fabricação estéreis (moléculas pequenas) em sacos flexíveis.

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Markets: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

Compliance: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), 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)

Use: Human, Veterinary

Batch Size: Large, Small, Medium

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

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

Region: Europe

Espanha

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.

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

BSL (Biological Safety Level): 1, 2

Use: Human, Veterinary

Batch Size: Large, Small, Medium

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, BIOLOGICS

Region: Europe

Espanha

Laboratorios Grifols | Barcelona Plant

Grifols International

Soluções de fabricação estéreis (pequenas moléculas) em sacos flexíveis e frascos.

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Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

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

Region: Europe

Batch Size: Large, Small, Medium

Use: Human, Veterinary

Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

Category / Product: FDF / DRUG PRODUCTS

Espanha

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Instalações de fabricação de injetáveis (lio e líquidos) e líquidos.

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

Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

Region: Europe

Batch Size: Large, Medium

Use: Human, Veterinary

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

Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

Compliance: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

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)

Category / Product: FDF / DRUG PRODUCTS

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

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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

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)

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.

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Compliance: 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)

Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

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

Therapeutic Areas of Expertise (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 (Biological Safety Level): 3, 4, 1, 2

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

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

Region: APAC

Batch Size: Large, Small, Medium

Use: Human

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CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Apoiamos o desenvolvimento de medicamentos com serviços de fabricação de pequenos lotes em todas as fases do processo de desenvolvimento de medicamentos.

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Registo

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CMO que combina instalações avançadas, controle de qualidade rigoroso e equipe especializada para fornecer soluções confiáveis, compatíveis e inovadoras.

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O Chile se posicionou como um dos mercados farmacêuticos mais estáveis e regulamentados da América Latina. Sob a supervisão do Instituto de Salud Pública (ISP), a fabricação farmacêutica no Chile segue rigorosas Buenas Prácticas de Manufactura (BPM), garantindo altos níveis de qualidade do produto, segurança e conformidade regulatória.

A parceria com empresas ISP Chile BPM CDMO permite que organizações farmacêuticas e de biotecnologia desenvolvam e fabricem medicamentos de acordo com os requisitos regulatórios chilenos, mantendo o alinhamento com os padrões internacionais de GMP reconhecidos na América Latina e nos mercados globais.

Por que escolher empresas ISP Chile BPM CDMO?

O Chile oferece uma combinação de confiabilidade regulatória, fabricação focada na qualidade e acesso aos mercados regionais. Os principais motivos para trabalhar com CDMOs de BPM do Chile incluem:

Supervisão regulatória do ISP: As atividades de fabricação são regulamentadas e inspecionadas pelo Instituto de Salud Pública (ISP).
Conformidade com BPM: os CDMOs chilenos operam sob Boas Práticas de Fabricação alinhadas com a OMS e os princípios internacionais de GMP.
Forte cultura de qualidade: ênfase em documentação, rastreabilidade e controle de processos.
Acesso ao mercado regional: O Chile serve como um ponto de entrada estratégico para os mercados farmacêuticos latino-americanos.
Ambiente regulatório estável: processos regulatórios previsíveis e estruturas de inspeção transparentes.

Principais serviços oferecidos por empresas ISP BPM CDMO

A maioria dos CDMOs chilenos compatíveis com BPM fornece uma variedade de serviços de desenvolvimento e fabricação farmacêutica, incluindo:

Suporte regulatório e de BPM: registros de ISP, inspeções, certificação de BPM e consultoria de conformidade.
Fabricação de medicamentos: comprimidos, cápsulas, líquidos, semissólidos e formas farmacêuticas não estéreis.
Fabricação estéril: injetáveis e produtos oftálmicos produzidos em ambientes controlados.
Fabricação de ensaios clínicos: produção BPM/GMP de materiais de ensaios clínicos.
Manufatura comercial: produção escalonável para os mercados chileno e latino-americano.
Controle de qualidade e estabilidade: testes analíticos, estudos de estabilidade e liberação de lote.

Vantagens da parceria com empresas chilenas de BPM CDMO

Escolher um CDMO compatível com BPM do ISP oferece vários benefícios operacionais e estratégicos:

Confiança regulatória: a supervisão do ISP fornece confiança para aprovações de produtos locais e regionais.
Preparação para o mercado: a fabricação local apoia uma entrada mais rápida no mercado do Chile.
Operações econômicas: custos de fabricação competitivos com padrões de qualidade sólidos.
Reconhecimento regional: a conformidade chilena com BPM é bem vista em toda a América Latina.
Instalações prontas para inspeção: sistemas de qualidade robustos e preparação para auditorias.