Aziende CDMO conformi alle GMP di Health Canada|
Conformità GMP in Canada e Servizi di Produzione

I tuoi CDMO canadesi di fiducia conformi agli standard GMP di Health Canada

Applied Filters:Health Canada (Canada GMP)×Clear All

Showing 23 facilities

Sort by:

Cina

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

Seacross Pharmaceutical Co Ltd

As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.

Discover our facility

AREE TERAPEUTICHE DI COMPETENZA (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 (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

SOSTANZE CONTROLLATE: 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

MERCATI: 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

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

REGIONE: APAC

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Health Canada, Servizio pubblico francese (CIR), PMDA (Giappone), MHRA (REGNO UNITO), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia), ANVISA (Brasile), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

Cina

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

Seacross Pharmaceutical Co Ltd

The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.

Discover our facility

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

SOSTANZE CONTROLLATE: 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

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

REGIONE: APAC

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS

Cina

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

Seacross Pharmaceutical Co Ltd

The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.

Discover our facility

AREE TERAPEUTICHE DI COMPETENZA (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

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

SOSTANZE CONTROLLATE: 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

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

REGIONE: APAC

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Health Canada, Servizio pubblico francese (CIR), PMDA (Giappone), MHRA (REGNO UNITO), NMPA (Cina), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia), ANVISA (Brasile), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS

Spagna

Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)

LABORATORIO REIG JOFRE SA

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

Discover our facility

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

REGIONE: Europe

COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP)

DIMENSIONE DEL LOTTO: Grande, Medio

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (J) Antiinfectives for systemic use

SOSTANZE CONTROLLATE: Lowest potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Spagna

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Injectable (lyo and liquid) and Liquid manufacturing facilities.

Discover our facility

BSL (Livello di sicurezza biologica): 3, 1, 2

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

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Medio

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

SOSTANZE CONTROLLATE: 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 (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Stati Uniti

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

Discover our facility

BSL (Livello di sicurezza biologica): 3, 1, 2

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

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

SOSTANZE CONTROLLATE: Lowest potential for abuse

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

REGIONE: North America

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Belgio

Cenexi Laboratoires Thissen

Cenexi

This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*.

Discover our facility

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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

REGIONE: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (Cina GMP), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Spagna

Grifols International | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

Discover our facility

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

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

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Spagna

Grifols International | Barcelona Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags and vials.

Discover our facility

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

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

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Paesi Bassi

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

Fabricación a gran escala de colesterol, vitamina D y análogos.

Discover our facility

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

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

REGIONE: Europe

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Servizio pubblico francese (CIR), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, COSMETICI, SERVICES

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1

DIMENSIONE DEL LOTTO: Piccolo

Francia

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Desarrollo personalizado y producción aséptica automatizada de medicamentos líquidos y liofilizados

Discover our facility

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

COMPLIANCE: Servizio pubblico francese (CIR), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

SOSTANZE CONTROLLATE: 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

REGIONE: Europe

USO: Umano

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

Spagna

Adare Pharma | EU

Adare Pharma Solutions

Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.

Discover our facility

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

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, Servizio pubblico francese (CIR), NMPA (Cina GMP), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

USO: Umano, Veterinario

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V01) Allergens, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

More facilities on the network

+17 more facilities

Create free account

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.

Discover our facility

REGIONE: Europe

USO: Umano

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

COMPLIANCE: ECOVADIS, MHRA (UK GMP)

DIMENSIONE DEL LOTTO: Piccolo, Medio

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Limited view

SERVICES manufacturing site

MAI network supplier

Tubilux Pharma: registered office; manufacturing facility

Location available after registration

Limited view

COSMETICI manufacturing site

MAI network supplier

COC Farmaceutici srl: commercial and administrative headquarters; manufacturing facility

Location available after registration

Limited view

COSMETICI manufacturing site

MAI network supplier

COC Farmaceutici srl: registered office; manufacturing facility

Location available after registration

Germania

Green Phoenix Labs GmbH

Cell Therapy company with excess Cleanroom capacity

Discover our facility

MERCATI: EMA (EU)

SERVIZI: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

REGIONE: Europe

USO: Umano

BSL (Livello di sicurezza biologica): 1

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

DIMENSIONE DEL LOTTO: Piccolo, Medio

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

COMPLIANCE: EMA (GMP UE)

CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS

Spagna

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

Discover our facility

MERCATI: EMA (EU), FDA (USA)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

BSL (Livello di sicurezza biologica): 1

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (S) Sensory organs, (V01) Allergens

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

…

Aziende CDMO conformi alle GMP di Health Canada

Health Canada applica un rigoroso quadro di Good Manufacturing Practices (GMP) per garantire la sicurezza, la qualità e l’efficacia dei prodotti farmaceutici destinati al mercato canadese. Collaborare con CDMO conformi a GMP Health Canada consente alle aziende farmaceutiche e biotecnologiche di rispettare le normative pur sfruttando le avanzate capacità produttive e la forte cultura della qualità del Canada.

Le CDMO canadesi conformi a GMP sono partner affidabili per sviluppo farmaceutico, forniture cliniche e produzione commerciale, supportando sia le approvazioni domestiche che le strategie regolatorie globali.

1Perché lavorare con le CDMO GMP Health Canada?

Conformità GMP Health Canada:

Piena adesione alle linee guida GMP canadesi (GUI-0001).

Allineamento regolatorio:

La GMP canadese è strettamente allineata agli standard FDA ed EMA.

Preparazione alle ispezioni:

Esperienza comprovata con audit e ispezioni di Health Canada.

Alti standard di qualità:

Forte attenzione ai sistemi di qualità, integrità dei dati e convalida dei processi.

Accesso ai mercati nordamericani:

Posizione strategica per forniture a Canada e Stati Uniti.

2Servizi principali offerti dalle CDMO GMP Health Canada

Supporto regolatorio e GMP:

Strategie di conformità Health Canada, audit GMP e supporto alla documentazione.

Produzione API:

Piccole molecole, intermedi e processi controllati.

Produzione di prodotti farmaceutici:

Forme solide orali, liquidi, semisolidi e prodotti sterili.

Materiali per studi clinici:

Produzione GMP per studi di Fase I–III.

Produzione commerciale:

Produzione scalabile per mercati canadese e internazionali.

Controllo qualità e stabilità:

Test analitici, programmi di stabilità e rilascio dei lotti.

Vantaggi di collaborare con le CDMO GMP canadesi

Fiducia regolatoria:

Riduzione dei rischi di non conformità grazie a operazioni GMP consolidate.

Accettazione globale:

La GMP Health Canada è riconosciuta dai principali enti regolatori internazionali.

Produzione scalabile:

Transizione fluida dallo sviluppo alla commercializzazione.

Affidabilità della supply chain:

Ambiente regolatorio stabile e infrastrutture solide.

Presenza produttiva in Nord America:

Strategica per le catene di fornitura multinazionali.

CDMO GMP Health Canada

Laboratorios Reig Jofre

Grifols

Pharmaron

FAES FARMA

Lannet CDMO

Cambrex

Aenova

Pagine correlate

Principali CDMO in America Principali CDMO in Canada Principali CDMO negli USA CDMO FDA cGMP

Trova il giusto partner CDMO GMP Health Canada con MAI CDMO

MAI CDMO Network connette aziende farmaceutiche e biotecnologiche con CDMO affidabili conformi a GMP Health Canada. Che tu necessiti di supporto allo sviluppo, produzione clinica o produzione commerciale su larga scala, ti aiutiamo a individuare partner allineati agli standard GMP canadesi e alle aspettative regolatorie globali.

Cerchi una CDMO conforme a Health Canada GMP? Contattaci per trovare il partner produttivo ideale per il tuo progetto.

Aziende CDMO conformi alle GMP di Health Canada

Aziende CDMO conformi alle GMP di Health Canada|Conformità GMP in Canada e Servizi di Produzione