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Injectables Contract Manufacturing Services

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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

White Raven - Legiapark
Belgium

White Raven - Legiapark

White Raven

Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.

OEB (Occupational Exposure Banding): 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)

MARKETS: EMA (EU)

REGION: Europe

USE: Human

BSL (Biological Safety Level): 1, 2

SERVICES: Manufacturing services, Packaging

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: BIOLOGICS, 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

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

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

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)

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

REGION: Europe

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)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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: BIOLOGICS, FDF / DRUG PRODUCTS

BAG Health Care
Germany

BAG Health Care

BAG Health Care GmbH

Parenteral F&F provider for vials in small to mid sized batches.

MARKETS: EMA (EU), MHRA (UK), TGA (Australia)

REGION: Europe

USE: Human, Veterinary

BSL (Biological Safety Level): 1

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

OEB (Occupational Exposure Banding): 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)

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Lifecore Injectables CDMO
United States

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

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

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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

SERVICES: 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 (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CONTROLLED SUBSTANCES: Lowest potential for abuse

OEB (Occupational Exposure Banding): 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)

REGION: North America

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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)

SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance 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, (J) Antiinfectives for systemic use, (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

EVER Pharma Jena GmbH
Germany

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

Specialized CDMO for development and production of small molecules injectables.

OEB (Occupational Exposure Banding): 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)

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

REGION: Europe

COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

CZ Vaccines | Large Scale Plant Portugal
Portugal

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Commercial Scale Facility

MARKETS: EMA (EU)

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

REGION: Europe

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

BATCH SIZE: Large, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

MARKETS: EMA (EU), ANVISA (Brazil), CDSCO (India)

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

REGION: Europe

COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BATCH SIZE: Small

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

CZ Vaccines | Large Scale Plant Spain
Spain

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

Single Use Commercial Scale Facility

MARKETS: EMA (EU)

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

REGION: Europe

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

BATCH SIZE: Large, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

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Injectable drugs are a critical component of modern medicine, requiring precision, sterility, and stringent regulatory compliance at every stage. Injectables Contract Development and Manufacturing Organizations (CDMOs) play a vital role in helping pharmaceutical companies bring these products to market quickly and efficiently. From development to large-scale production, injectables CDMOs offer tailored solutions to meet the unique needs of each project.

How to Choose an Injectables Contract Manufacturer

Choosing the right injectables contract manufacturer is essential for ensuring product safety, efficacy, and compliance. Start by evaluating their expertise in sterile manufacturing and their track record with similar products. Ensure the CDMO holds certifications from global regulatory bodies like EMA, FDA, and WHO to guarantee full compliance across markets.

It’s also important to visit the manufacturer’s facilities to assess their technology, cleanliness, and aseptic processing capabilities. Finally, consider their scalability—whether they can handle both small clinical trial batches and large commercial-scale production seamlessly.

Key Services Offered by Injectables CDMOs

  • Formulation Development: Expertise in developing stable and effective formulations for a variety of injectable formats, including aqueous, oil-based, and suspensions.
  • Aseptic Manufacturing: Advanced sterile manufacturing capabilities to ensure product safety and efficacy, including lyophilization and high-containment technologies.
  • Regulatory Support: Assistance with filings and compliance for global regulatory bodies such as EMA, FDA, and WHO to ensure smooth market entry.
  • Packaging Solutions: Tailored primary and secondary packaging for injectable products, ensuring proper sterility, stability, and adherence to regulatory standards.
  • Analytical Testing: Comprehensive testing to ensure the safety, stability, and consistency of injectable formulations throughout the production process.

Advantages of Partnering with Injectables Manufacturers

  • Regulatory Compliance: Injectables CDMOs are well-versed in global regulatory standards, ensuring products meet the highest safety and efficacy benchmarks.
  • State-of-the-Art Facilities: Equipped with advanced technologies, including aseptic and high-containment manufacturing, injectables manufacturers offer superior quality and precision.
  • Flexibility and Scalability: Whether for small clinical batches or full-scale commercial production, injectables CDMOs offer adaptable solutions to meet evolving project needs.
  • Time-to-Market Efficiency: By leveraging streamlined processes and regulatory expertise, injectables manufacturers can reduce production timelines and accelerate market entry.
  • Cost Efficiency: Injectables CDMOs provide cost-effective production without sacrificing quality, making them a smart choice for pharmaceutical partnerships.

Injectables CDMO Companies

Some of the top injectables CDMO companies include:

  • Cenexi: Injectables manufacturing. [See CDMO profile]
  • Liof Pharma: Aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]
  • CDM Lavoisier: Specialized in manufacturing glass ampoules, glass vials, and plastic (BFS) ampoules. [See CDMO profile]
  • ASCIL Biopharm: Laboratories and pilot plant for technical and clinical batches of sterile products. [See CDMO profile]
  • Reig Jofre: Injectable development and manufacturing with state-of-the-art facilities. [See CDMO profile]
  • VIVUNT PHARMA: CDMO for injectable oncology drugs. [See CDMO profile]
  • Grifols: Injectables manufacturing CDMO. [See CDMO profile]
  • Huiyu Pharmaceuticals Co., Ltd: dedicated to the development and production of complex and high-value dosage forms. [See CDMO profile]
  • i+Med: Developer and manufacturer of new drug products with controlled-release technologies. [See CDMO profile]
  • Aenova Group: Competence Center animal health products and sterile technologies. [See CDMO profile]
  • HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
  • Basic Pharma Manufacturing: can bring your pharmaceuticals from lab scale to the early clinical phase and beyond. [See CDMO profile]
  • Adragos Pharma: specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish. [See CDMO profile]
  • CZ Vaccines: Clinical Trials Facility. [See CDMO profile]
  • BAG Health Care: Parenteral F&F provider for vials in small to mid-sized batches. [See CDMO profile]
  • Darnytsia Kyiv: Pharmaceutical manufacturing organization combining advanced production facilities, rigorous quality control systems, and highly qualified staff to deliver reliable, compliant, and innovative solutions for its clients. [See CDMO profile]
  • Green Phoenix Labs GmbH: Cell therapy company offering excess GMP cleanroom capacity to support advanced therapy manufacturing projects. [See CDMO profile]
  • White Raven: Fill-and-finish site dedicated to GMP formulation and aseptic filling of sterile liquid injectable products. [See CDMO profile]
  • Bilthoven Biologicals Drug Substance and Drug Product Facilities: Multi-product GMP facilities for Drug Substance and Drug Product. [See CDMO profile]
  • PRASFARMA: CMO/CDMO specialized in cytostatics and high potency products. [See CDMO profile]
  • Ascendia Pharmaceutical Solutions: GMP-certified CDMO for advanced sterile and non-sterile pharmaceutical manufacturing, formulation development, and analytical testing. [See CDMO profile]
  • Lifecore Injectables CDMO: Clinical and commercial manufacturing of sterile injectable drug products. [See CDMO profile]
  • Seda Pharma Development Services: Integrated pharmaceutical development and clinical pharmacology services supporting efficient development of optimal medicinal products, from conventional to complex formulations. [See CDMO profile]

Related Information

Let MAI CDMO Network Help You Find the Right Injectables CDMO Partner

Selecting the right injectables CDMO partner can be a complex process, but MAI CDMO Network simplifies it. We connect you with pre-vetted injectables manufacturers that meet your project’s specific needs, ensuring your product is developed, manufactured, and delivered efficiently.

Our team of experts provides personalized support to align your project goals with the strengths of leading injectables CDMOs, ensuring a successful partnership from development to commercialization.

Contact us today to explore the best injectables contract manufacturers and take your pharmaceutical journey to the next level with a trusted partner.