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Health Canada GMP CDMO Companies
Canadian GMP Compliance & Manufacturing Services

Your Trusted Canadian CDMOs Compliant with Health Canada GMP Standards

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Showing 49 facilities
HIPRA BIOTECH SERVICES | Aiguaviva
Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

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

BATCH SIZE: Small, Medium, Large

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

REGION: Europe

USE: Human

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

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

CATEGORY / PRODUCT: BIOLOGICS

BSL (Biological Safety Level): 1, 2

Adare Pharma | EU
Italy

Adare Pharma | EU

Adare Pharma Solutions

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

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MARKETS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), 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, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), 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), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

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 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Adare Pharma | US
United States

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci

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MARKETS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), 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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), 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), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

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 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

REGION: North America

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS

REGION: Europe

USE: Human

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

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

Laboratorios Grifols | Murcia Plant
Spain

Laboratorios Grifols | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

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

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

REGION: Europe

USE: Human, Veterinary

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

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

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

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

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

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 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

BSL (Biological Safety Level): 1, 2

HBM Pharma
Slovakia

HBM Pharma

Hbm Pharma

EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms

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MARKETS: Turkish Health Authorities, ANVISA (Brazil), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil), TGA (Australia GMP), NMPA (China GMP), ECOVADIS, ISO, Health Canada (Canada GMP)

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Manufacturing services, Packaging, Quality Assurance services

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

CONTROLLED SUBSTANCES: High potential for abuse & medical use

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spain

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

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

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

BATCH SIZE: Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

CONTROLLED SUBSTANCES: Lowest potential for abuse

REGION: Europe, APAC, LATAM, North America, MENA

USE: Human, Veterinary

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

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

BSL (Biological Safety Level): 1

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use

Laboratorios Grifols | Barcelona Plant
Spain

Laboratorios Grifols | Barcelona Plant

Grifols International

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

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

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

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 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spain

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Injectable (lyo and liquid) and Liquid manufacturing facilities.

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BATCH SIZE: Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

REGION: Europe

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

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

USE: Human, Veterinary

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

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

Pharmaron API Commercial Synthesis Cramlington (UK)
United Kingdom

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Commercial API Small Molecules Synthesis.

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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, Manufacturing services, Regulatory services, Development services, Quality Assurance services

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

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

Lifecore Injectables CDMO
United States

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

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MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, 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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

CONTROLLED SUBSTANCES: Lowest potential for abuse

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

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 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

REGION: North America

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Health Canada enforces a robust Good Manufacturing Practices (GMP) framework to ensure the safety, quality, and efficacy of pharmaceutical products manufactured or supplied to the Canadian market. Partnering with Health Canada GMP CDMO companies enables pharmaceutical and biotech organizations to achieve regulatory compliance while leveraging Canada’s advanced manufacturing capabilities and strong quality culture.

Canadian GMP-compliant CDMOs are trusted partners for drug development, clinical supply, and commercial manufacturing, supporting both domestic approvals and global regulatory strategies.

Why Work with Health Canada GMP CDMO Companies?

Canada has established itself as a reliable hub for regulated pharmaceutical manufacturing. Companies choose Canadian GMP CDMOs for several strategic reasons:

  • Health Canada GMP Compliance: Full adherence to Canadian GMP guidelines (GUI-0001).
  • Strong Regulatory Alignment: Canadian GMP closely aligns with FDA and EMA requirements.
  • Inspection Readiness: Proven experience with Health Canada inspections and audits.
  • High Quality Standards: Strong focus on quality systems, data integrity, and validation.
  • Access to North American Markets: Strategic location for supply to Canada and the US.

Key Services Offered by Health Canada GMP CDMO Companies

Most of the Canadian GMP CDMOs provide comprehensive pharmaceutical development and manufacturing services, including:

  • Regulatory & GMP Support: Health Canada compliance strategy, GMP audits, and dossier support.
  • API Manufacturing: Small molecule APIs, intermediates, and controlled processes.
  • Drug Product Manufacturing: Oral solid dosage forms, liquids, semi-solids, and sterile products.
  • Clinical Trial Material: GMP manufacturing for Phase I–III studies.
  • Commercial Manufacturing: Scalable production for Canadian and international markets.
  • Quality Control & Stability: Analytical testing, stability programs, and batch release.

Advantages of Partnering with Canadian GMP CDMO Companies

Working with a Health Canada GMP-compliant CDMO delivers significant operational and regulatory benefits:

  • Regulatory Confidence: Reduced compliance risk through experienced GMP operations.
  • Global Acceptance: Health Canada GMP is recognized by major international regulators.
  • Scalable Manufacturing: Smooth transition from development to commercialization.
  • Supply Chain Reliability: Stable regulatory environment and strong infrastructure.
  • North American Manufacturing Footprint: Strategic for multinational supply chains.

Health Canada GMP CDMO Companies

Examples of CDMO companies operating under Health Canada GMP include:

  • Laboratorios Reig Jofre: Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities, cGMP facilities suitable for the Canadian pharmaceutical market. [See CDMO profile]
  • Grifols: Sterile manufacturing solutions (small molecules) in flexible bags. [See CDMO profile]
  • Pharmaron: International CDMO offering commercial API small-molecule synthesis under cGMP standards aligned with Health Canada requirements for supply to Canada and global markets. [See CDMO profile]
  • FAES FARMA: Developer and manufacturer of human medicinal products. [See CDMO profile]
  • Lannet CDMO: Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids. [See CDMO profile]
  • Cambrex: Our 400+ team members in Charles City specialize in late-phase and commercial API development and cGMP manufacturing. [See CDMO profile]
  • Aenova: Competence Center and one-stop shop for Soft gelatin capsules and VegaGels®. [See CDMO profile]
  • HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
  • CARBOGEN AMCIS: Custom formulation development and GMP sterile manufacture of liquid and lyophilized drug product, aligned with Health Canada cGMP regulations. [See CDMO profile]
  • Adare Pharma: Adare Pharma is a global CDMO with sites in US and EU providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal Health and OTC markets. [See CDMO profile]

Related Pages

Find the Right Health Canada GMP CDMO Partner with MAI CDMO

MAI CDMO Network connects pharmaceutical and biotech companies with trusted Health Canada GMP CDMO companies. Whether you need development support, clinical manufacturing, or commercial-scale production, we help you identify partners aligned with Canadian GMP standards and global regulatory expectations.

Need a Health Canada GMP-compliant CDMO? Contact us to find the right manufacturing partner for your project.