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Injectable BFS CDMO
Blow-Fill-Seal Manufacturing Services

Your Trusted Injectable BFS CDMO Partners for Blow-Fill-Seal Manufacturing Services and Sterile Injectable Drugs Development

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Adragos Pharma | Halden
Norway

Adragos Pharma | Halden

Adragos Pharma

We specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.

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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

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

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

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FDF / DRUG PRODUCTS manufacturing site

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Solutions for non Viral Delivery programs

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FDF / DRUG PRODUCTS manufacturing site

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One-stop CDMO Solutions for APl and Key intermediates.

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FDF / DRUG PRODUCTS manufacturing site

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Make affordable healthcare solutions that improve and simplify patients lives.

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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

Lifecore Injectables CDMO
United States

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

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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

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: 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.

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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.

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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.

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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

Laboratorios Grifols | Murcia Plant
Spain

Laboratorios Grifols | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

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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

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Blow-Fill-Seal (BFS) technology is revolutionizing sterile manufacturing by combining container formation, aseptic filling, and sealing in a single automated step. For injectable drug products, BFS offers unmatched sterility assurance and efficiency. That’s why pharmaceutical companies rely on specialized injectable BFS CDMO partners to produce high-quality, ready-to-use formats at scale.

Through integrated blow-fill-seal manufacturing services, BFS CDMOs enable rapid production of preservative-free, single-use, and multi-dose injectable products in full compliance with global regulatory standards.

Why Choose an Injectable BFS CDMO

Working with an experienced CDMO ensures:

  • Aseptic production with minimal human intervention
  • Proven compliance with FDA, EMA, and WHO GMP standards
  • High-throughput manufacturing for large-volume sterile injectables
  • Format versatility: unit-dose, multi-dose, twist-off, and reclosable systems
  • Preservative-free formulations for ophthalmic, nasal, or pediatric use
  • Container integrity and sterility testing per USP and Ph. Eur. standards
  • Custom BFS design to meet patient and market requirements

BFS is ideal for injectable therapies requiring efficiency, sterility, and ease of use.

Key Services Offered by Blow-Fill-Seal Manufacturing Services Providers

Top-tier providers of blow-fill-seal manufacturing services for injectables typically offer:

  • Sterile formulation development tailored to BFS processing
  • BFS container engineering and mold design
  • GMP BFS production in ISO 5/Class 100 environments
  • Filling of liquids, emulsions, or suspensions for parenteral use
  • Integrated sterilization and packaging solutions
  • Microbiological and particulate control testing
  • Cold chain storage and logistics, if needed
  • Regulatory submission support (e.g., ANDA, NDA, EU dossiers)

These services ensure injectable BFS products are compliant, scalable, and market-ready.

Advantages of Partnering with Injectable BFS CDMOs

Choosing the right CDMO brings multiple advantages:

  • Improved sterility assurance via closed-system processing
  • Reduced production costs with fewer steps and lower contamination risk
  • Enhanced patient safety through preservative-free delivery
  • Faster market access due to integrated development and filling
  • Sustainable and compact packaging for global distribution

BFS technology simplifies the path from formulation to finished injectable product.

Injectable BFS CDMO Companies

Some of the most recognized injectable BFS CDMO providers include:

  • CDM Lavoisier: CDMO specialized in the manufacturing of glass ampoules, glass vials, and plastic (BFS) ampoules. [See CDMO profile]
  • Adragos Pharma: Specializes in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill & finish. [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]

Related Information

Let MAI CDMO Network Help You Find the Right BFS CDMO Partner for Injectable Drugs

At MAI CDMO Network, we help pharma and biotech companies connect with leading injectable BFS CDMOs providers offering full-service blow-fill-seal manufacturing services. Whether you’re launching a preservative-free injectable or scaling a global product, we’ll guide you to the partner that meets your technical, regulatory, and commercial needs.

Contact us today and let’s find your ideal CDMO partner.