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Injectables Contract Manufacturing Services

Your Trusted Injectables CDMO Partners for Injectables Contract Manufacturing and Development

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Liof Pharma S.L.U.
Spain

Liof Pharma S.L.U.

Liof Pharma S.L.U.

Socio CDMO de confianza para la fabricación aséptica y liofilización de productos biológicos y medicamentos inyectables.

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BATCH SIZE: Small

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), FDA (cGMP)

REGION: Europe

MARKETS: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), INVIMA (Colombia), MHRA (UK)

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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

BSL (Biological Safety Level): 1

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

Adragos Pharma | Halden
Spain

Adragos Pharma | Halden

Adragos Pharma

Nos especializamos en la fabricación de bolsas intravenosas, ampollas y viales de plástico utilizando la tecnología Blow-Fill-Seal (BFS) y otras formas de dosif

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MARKETS: Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

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), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

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

REGION: Europe

USE: Human

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

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents, (A) Digestive tract and metabolism, (D) Dermatologicals, (V06) Nutrients

CZ Vaccines | Investigational and Medicinal Products Plant
Spain

CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines

Instalación de Ensayos Clínicos

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BATCH SIZE: Small

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS, CHEMICAL-SYNTHETIC

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

REGION: Europe

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

USE: Human

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

BSL (Biological Safety Level): 2

Adragos Pharma | Livron
Spain

Adragos Pharma | Livron

Adragos Pharma

Fabricación de líquidos estériles y supositorios. Manejamos más de 100 moléculas y ofrecemos estudios de estabilidad, manejo de narcóticos y servicios de anális

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BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, COSMETICS, SERVICES, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU 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

USE: Human

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

MARKETS: PMDA (Japan), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals

Adragos Pharma | Athens
Spain

Adragos Pharma | Athens

Adragos Pharma

Socio global CDMO, ofreciendo servicios de Desarrollo y Fabricación para productos farmacéuticos.

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MARKETS: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, CHEMICAL-SYNTHETIC

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), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)

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 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

CONTROLLED SUBSTANCES: High potential for abuse & medical use

Cenexi Hérouville Saint Clair
France

Cenexi Hérouville Saint Clair

Cenexi

The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquids.

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BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

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

USE: Human

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system

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

CONTROLLED SUBSTANCES: High potential for abuse & no medical use, High potential for abuse & medical use

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Nuestra planta ofrece una fabricación de primer nivel de comprimidos y ampollas, un servicio al cliente excepcional en inglés y japonés, y cuenta con más de 330

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CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

MARKETS: EDE (UAE), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP)

BATCH SIZE: Large

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

USE: Human

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

REGION: APAC

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

Grifols International | Barcelona Plant
Spain

Grifols International | 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, OLIGONUCLEOTIDES, CHEMICAL-SYNTHETIC

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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

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

Grifols International | Murcia Plant
Spain

Grifols International | 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, OLIGONUCLEOTIDES, CHEMICAL-SYNTHETIC

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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (J) Antiinfectives for systemic use, (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, CHEMICAL-SYNTHETIC

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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

Capacidades internas integrales, desde el desarrollo de líneas celulares hasta la fabricación comercial

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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, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC

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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

PRASFARMA
Spain

PRASFARMA

PRASFARMA

CMO/CDMO de citostáticos y productos de alta potencia

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MARKETS: Turkish Health Authorities, ANVISA (Brazil), EMA (EU), SFDA (Saudi Arabia), NMPA (China), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), ICH

REGION: Europe

BSL (Biological Safety Level): 3, 4

USE: Human

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

CONTROLLED SUBSTANCES: High potential for abuse & medical use

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

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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.