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Ampoule Filling CDMO Companies
Injectable Ampoule Manufacturing Services

Your Trusted Partners for Injectable Ampoule Manufacturing and Development

Applied Filters:Injectables×Glass ampoules×FDF / DRUG PRODUCTS×Clear All
Showing 17 facilities
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

EVER Pharma Jena GmbH
Germany

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

Specialized CDMO for development and production of small molecules injectables.

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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: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), 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, 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, (N) Nervous system

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

BSL (Biological Safety Level): 1, 2

Adragos Pharma | Athens
Greece

Adragos Pharma | Athens

Adragos Pharma

Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.

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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

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)

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, Development services, Packaging, Quality Assurance services

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

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Our facility provides best-in-class manufacturing of tablets and ampoules.

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CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

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

Adragos Pharma | Livron
France

Adragos Pharma | Livron

Adragos Pharma

Manufacture of sterile liquids and suppositories. We handle more than 100 molecules, narcotics management, and analysis and stability services.

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BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

Cenexi
France

Cenexi

Cenexi

GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.

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BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), NMPA (China 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, Veterinary

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

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, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents

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

STE PRASFARMA
Spain

STE PRASFARMA

STE PRASFARMA

CMO/CDMO cytostatics and high potency products.

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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

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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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Production facility that complies with the latest GMP standards for sterile and aseptic liquids, particularly glass ampoules.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

One-stop CDMO Solutions for APl and Key intermediates.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Leading provider of sterile pharmaceutical manufacturing services that operates a state-of-the-art facility in India

Location available after registration

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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: 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.

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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

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Glass ampoules remain a gold standard for sterile injectable products, offering tamper-evident packaging, excellent chemical stability, and full protection from contamination. Whether you’re developing high-purity injectable solutions or single-dose formulations, partnering with experienced ampoule filling CDMO companies ensures precise filling, clean sealing, and global regulatory compliance.

Through integrated filling services, these CDMOs support full lifecycle development and commercial production of ampoule-based drug products — from early-stage batches to large-scale GMP supply.

How to Choose Ampoule Filling CDMO Companies

When selecting among ampoule filling CDMO companies, key considerations include:

  • Compatibility with ampoule types: flame-sealed, scored, break ring, or OPC (one-point cut)
  • Aseptic and terminal sterilization capabilities
  • Support for various fill volumes (typically 1 mL to 25 mL)
  • Speed and automation level of ampoule filling and sealing lines
  • Cleanroom environment standards (ISO 5/Class 100)
  • Proven regulatory track record: FDA, EMA, PMDA, etc.
  • Inspection, labeling, and packaging capabilities under GMP

A qualified ampoule CDMO ensures high-volume precision, sterility, and full documentation from batch to batch.

Key Services Offered by Injectable Ampoules Manufacturing Partners

Leading services in injectable ampoules manufacturing typically include:

  • Sterile formulation and filtration
  • Automated ampoule filling and flame sealing
  • Glass ampoule sourcing and customization
  • Aseptic or terminal sterilization (depending on formulation)
  • Visual inspection (manual or automated)
  • Labeling, cartoning, and serialization
  • Container closure integrity testing (CCIT)
  • Cold chain storage, if applicable
  • Regulatory and QA documentation for submissions and audits

These services support sterile injectables in oncology, emergency medicine, ophthalmology, and more.

Advantages of Partnering with Ampoules CDMO Companies

Collaborating with expert ampoules manufacturing CDMO companies offers multiple benefits:

  • High chemical stability thanks to inert glass containers
  • Full sterility assurance via flame-sealed, tamper-evident packaging
  • Reduced risk of contamination and interaction with external environments
  • Fast production cycles with high-speed filling lines
  • Strong global acceptance of ampoules for regulatory submissions

Ampoules are ideal for single-dose injectable drugs requiring safety, purity, and long-term storage.

Ampoule Filling CDMO Companies

Some of the most trusted ampoule filling CDMO companies include:

  • Cenexi: GMP plant on a four-hectare site located 9 km east of Paris. A center of excellence for injectable ampoules. [See CDMO profile]
  • CDM Lavoisier: Specialized in the manufacturing of glass ampoules, glass vials, and plastic (BFS) ampoules. [See CDMO profile]
  • i+Med: Developer and manufacturer of innovative drug products featuring controlled-release technologies. [See CDMO profile]
  • Adragos Pharma: Facility offering best-in-class production of tablets and ampoules. [See CDMO profile]
  • Darnytsia Kyiv: Pharmaceutical manufacturing organization combining advanced facilities, stringent quality control, and expert staff to deliver reliable, compliant, and innovative solutions for its clients. [See CDMO profile]
  • PRASFARMA: CMO/CDMO specialized in cytostatics and high potency products. [See CDMO profile]
  • Demo facility: Facility focused on tissue therapy, cell therapy and GTMP (Gene Therapy). [See CDMO profile]

Related Information

Let MAI CDMO Help You Find the Right Filling Partner

At MAI CDMO, we connect pharma and biotech companies with experienced ampoules CDMO companies offering complete injectable ampoule manufacturing solutions. From early development to commercial-scale production, we help you find a sterile manufacturing partner that meets your product’s technical, regulatory, and operational needs.

Ready to launch or scale your ampoule-based injectable? Contact us today and find your ideal CDMO.