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Leading CDMO Companies in Spain

Your Trusted Spanish Partners for Contract Manufacturing and Development

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HIPRA BIOTECH SERVICES | Aiguaviva
Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

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

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 > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

REGION: Europe

CATEGORY / PRODUCT: BIOLOGICS

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
Spain

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

HISTOCELL

Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.

SERVICES: Development services, Analytical / QC 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), CDSCO (India), TGA (Australia)

COMPLIANCE: ISO, EMA (EU GMP)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

REGION: Europe

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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 > 10,000 µg/day)

REGION: Europe

Laboratorios Grifols | Murcia Plant
Spain

Laboratorios Grifols | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

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 > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

REGION: Europe

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

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

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, Veterinary

BATCH SIZE: Large, Small, Medium

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

REGION: Europe

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.

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

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

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 (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BATCH SIZE: Large, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1

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

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

CONTROLLED SUBSTANCES: Lowest potential for abuse

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Laboratorios Grifols | Barcelona Plant
Spain

Laboratorios Grifols | Barcelona Plant

Grifols International

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

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

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)

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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.

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

VIVEbiotech
Spain

VIVEbiotech

VIVEbiotech

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

MARKETS: EMA (EU), FDA (USA), MHRA (UK)

REGION: Europe

COMPLIANCE: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS

53Biologics Production Plant
Spain

53Biologics Production Plant

53Biologics

53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.

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

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: BIOLOGICS

BDI biotech Production Plant
Spain

BDI biotech Production Plant

BDI biotech

We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

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

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Regulatory services

REGION: Europe

COMPLIANCE: ISO

BSL (Biological Safety Level): 1

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: BIOLOGICS

Cultiply
Spain

Cultiply

Cultiply

Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.

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), CDSCO (India), TGA (Australia)

REGION: Europe

COMPLIANCE: ISO

BSL (Biological Safety Level): 1, 2

SERVICES: Development services, Manufacturing services

CONTROLLED SUBSTANCES: Lowest potential for abuse

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: BIOLOGICS

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

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Spain has established itself as a hub for Contract Development and Manufacturing Organizations (CDMOs) in the pharmaceutical industry. These companies provide a full spectrum of services, from drug development to commercial manufacturing, supporting global pharmaceutical and biotech firms in bringing innovative products to market.

Why Choose CDMOs in Spain?

Known for advanced facilities and compliance, Spanish CDMOs offer regulatory expertise and competitive pricing. These companies cater to a wide range of dosage forms, including oral solids, injectables, and specialized formulations like lyophilized products. With certifications from global regulatory bodies such as EMA and FDA, CDMOs in Spain are equipped to handle projects for preclinical, clinical, and commercial phases.

Driven by technological capabilities, Spanish CDMOs excel in areas such as formulation development, process optimization, and analytical testing. Their strategic location within Europe provides excellent access to global markets, ensuring streamlined logistics and efficient distribution. By leveraging cutting-edge technologies, these organizations offer innovative solutions for even the most complex pharmaceutical challenges.

Key Services Offered by pharmaceutical contract manufacturers in Spain

Optimizing formulations during Drug Development: Formulation development, process optimization, and analytical testing.

Scaling production via Manufacturing: High-volume production of oral solids, semi-solids, liquids, and parenterals.

Assuring compliance with Regulatory Support: Assistance with filings for EMA, FDA, and other global markets.

Customizing delivery with Packaging Solutions: Primary and secondary packaging tailored to product needs.

Advantages of Partnering with Spanish CDMOs

Ensuring compliance through Regulatory Expertise: Comprehensive knowledge of European and global pharmaceutical standards.

Utilizing high-containment technology in State-of-the-Art Facilities: Advanced technologies for aseptic processing and high containment manufacturing.

Optimizing supply logistics via a Strategic Location: Proximity to major European markets ensures streamlined logistics.

Maximizing value with Cost Efficiency: Competitive pricing without compromising on quality.

Aligning with environmental goals through Sustainability Practices: Many CDMOs in Spain adopt environmentally friendly practices to align with global sustainability goals.

CDMO Companies in Spain

Several CDMO pharma companies in Spain stand out for their expertise and capabilities:

Grifols International: Injectables manufacturing. [See CMO profile]

FAES FARMA: Spanish manufacturer of human medicinal products. [See CMO profile]

Pharmaloop (a Salvat Company): Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets. [See CDMO profile]

Reig Jofre: Development and manufacturing services for finished dosage forms (FDF): sterile liquids, lyophilizates, non-sterile liquids and betalactam antibiotics. [See CDMO profile]

Liof Pharma: Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]

HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]

Histocell: Spanish CDMO that develops cell therapies from iPSCs, MSCs, secretomes, exosomes and other types of cells, as well as medical devices and dermocosmetic products. [See CDMO profile]

VIVEbiotech: Leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]

VIVUNT PHARMA: CMO of sterile oncology drugs. Liquid and lyophilized vials fully compliant with new Annex 1 EU GMP. [See CMO profile]

53Biologics: Spanish CDMO specialized in biologics production, from DNA to proteins, offering preclinical to cGMP manufacturing. [See CDMO profile]

Cultiply: Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products. [See CDMO profile]

BDI biotech: Works as an R&D department specialized in strain and bioprocess development, scale-up and batch production. [See CDMO profile]

Ascil Biopharm: R&D and pharmaceutical development, with laboratories and a pilot plant for technical and clinical batches of sterile products. [See CDMO profile]

i+Med: Developer and manufacturer of innovative drug products with advanced controlled-release technologies. [See CDMO profile]

Rioja Nature Pharma: Spanish CDMO specialized in nutraceuticals and food supplements. [See CDMO profile]

MENADIONA S.L: Contract development and manufacturing partner for APIs, intermediates and fine chemicals, specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. [See CDMO profile]

Sylentis: Spanish manufacturer specialized in the production of oligonucleotides. [See CDMO profile]

CZ Vaccines: Clinical trials and single-use commercial scale facility for biologics and vaccines. [See CDMO profile]

TRADICHEM INDUSTRIAL SERVICES: HIPERING® Technology, a next-generation platform designed to streamline and enhance lean pharmaceutical manufacturing. [See CDMO profile]

AMSbiopharma: Provides analytical services supporting pharmaceutical, biopharmaceutical and chemical industries across all stages of drug development. [See CDMO profile]

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Let MAI CDMO Network Help You Find the Right Partner

Finding the right CDMO partner can be challenging, but MAI CDMO makes it easy. We connect you with pre-vetted CDMOs in Spain that meet your specific requirements, ensuring your project’s success from development to market. Our team of experts provides personalized support to align your project goals with the strengths of Spanish CDMOs.

Whether you’re in the early stages of drug development or seeking a partner for commercial production, MAI CDMO offers unmatched expertise in the pharmaceutical industry.

Contact us today to explore the top CDMO companies in Spain and start your pharmaceutical journey with a trusted partner.