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Sterile BFS CDMO
Blow-Fill-Seal Contract Manufacturing Services

Your Trusted Partners for Blow-Fill-Seal Contract Manufacturing and Aseptic Liquid Packaging

Applied Filters:Sterile forms (ophtalmic, nasal, otic)×BFS (Blow Fill Seal) ampoules×FDF / DRUG PRODUCTS×Clear All
Showing 9 facilities
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)

PHARMALOOP S.L. - a Salvat Company
Spain

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

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BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

COMPLIANCE: EMA (EU GMP), FDA (cGMP), ISO

REGION: Europe

USE: Human

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

MARKETS: FDA (USA), EMA (EU)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V01) Allergens, (S) Sensory organs

BSL (Biological Safety Level): 1

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

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CDMO specializing in sterile unit-dose liquid drug products using Blow-Fill-Seal (BFS) technology for ophthalmic, nasal and inhalation therapies.

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

Make affordable healthcare solutions that improve and simplify patients lives.

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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

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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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)

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, 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)

BATCH SIZE: Large, Small, Medium

USE: Human

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

Aenova Group - Location Latina, Italy
Italy

Aenova Group - Location Latina, Italy

Aenova

Competence Center animal health products and sterile technologies.

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MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU 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: FDF / DRUG PRODUCTS

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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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), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), NSF

BATCH SIZE: Large, Small, Medium

USE: Human

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

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

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.

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COMPLIANCE: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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)

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

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BSL (Biological Safety Level): 3, 4, 1, 2

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

BATCH SIZE: Large, Small, Medium

USE: Human

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.

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THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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)

BSL (Biological Safety Level): 3, 4, 1, 2

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

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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), SQF (Safe Quality Food), NSF

BATCH SIZE: Large, Small, Medium

USE: Human

CATEGORY / PRODUCT: SERVICES, FDF / DRUG PRODUCTS

Ophtapharm, a Sentiss Company
Switzerland

Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility.

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MARKETS: EMA (EU), FDA (USA)

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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Blow-Fill-Seal (BFS) technology is the gold standard for aseptic filling of sterile liquid products, combining container formation, sterile filling, and sealing in a single automated step. Whether you’re manufacturing ophthalmics, respiratory treatments, or injectable solutions, a reliable sterile BFS CDMO ensures unmatched sterility, efficiency, and compliance.

With complete blow-fill-seal contract manufacturing capabilities, these CDMOs deliver scalable, GMP-compliant production of sterile single-dose and multi-dose containers for global markets.

Why Choose a CDMO for Blow-Fill-Seal

Partnering with an experienced BFS CDMO for sterile drugs offers:

  • Integrated container formation and aseptic filling in ISO 5 conditions
  • Minimal human intervention, reducing contamination risk
  • Compatibility with unit-dose, multi-dose, and twist-off formats
  • Support for ophthalmic, nasal, oral, injectable, and respiratory therapies
  • Preservative-free system options
  • Regulatory readiness (FDA, EMA, WHO PQ, etc.)
  • Scalability from clinical to high-volume commercial batches

BFS is especially well-suited for sterile products where safety, speed, and format flexibility are essential.

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

Leading blow-fill-seal contract manufacturing companies typically offer:

  • Formulation development for low-viscosity sterile liquids
  • Container design and customization (LDPE, PP)
  • Sterile BFS filling for volumes from 0.2 mL to 100 mL+
  • Single-dose and multi-dose formats with tamper-evident designs
  • Microbiological and particulate control testing
  • Cold chain management, if required
  • Labeling, secondary packaging, and serialization
  • Regulatory support for ANDA, NDA, and EU submissions

These services support BFS products for ophthalmology, ENT, pulmonology, wound care, and more.

Advantages of Partnering with a BFS CDMO

Collaborating with a qualified BFS CDMO offers key benefits:

  • Superior sterility assurance with closed-system processing
  • Lower production costs due to high-speed automation
  • Ideal for preservative-free products, especially for pediatric or ophthalmic use
  • Reduced packaging waste and improved dosing accuracy
  • Fast time to market with integrated fill-finish and packaging solutions

BFS is the solution of choice for high-volume, patient-friendly sterile liquids.

Sterile BFS CDMO Companies

Some of the most trusted sterile BFS CDMO providers include:

  • 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]
  • Adragos Pharma: Specialized in IV bags, plastic ampoules, and vials using BFS technology; sterile ophthalmic, nasal, and otic formats. [See CDMO profile]
  • Liof Pharma S.L.U.: Aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]
  • ASCIL Biopharm: R&D and pharmaceutical development for technical and clinical batches of sterile products. [See CDMO profile]
  • FAES FARMA: Developer and manufacturer of human medicinal products. [See CDMO profile]
  • Huiyu Pharmaceuticals Co., Ltd: Development and production of complex dosage forms including implants, OSD, and sterile formulations. [See CDMO profile]
  • Content Group: Manufacturing of sterile ophthalmic, nasal, and otic forms, and FDF/DRUG formulations. [See CDMO profile]
  • i+Med: Developer of new drug products with controlled-release technologies including sterile presentations. [See CDMO profile]
  • Cenexi: Specializes in manufacturing and filling of injectable and non-injectable sterile liquid products. [See CDMO profile]
  • Aenova Group: Competence center for animal health products and advanced sterile technologies. [See CDMO profile]
  • Basic Pharma: Tailored CDMO services for OSD and sterile ophthalmic formats. [See CDMO profile]
  • Ophtapharm (Sentiss): Ophthalmic and otic solutions, suspensions, emulsions, ointments, and gels – FDA-approved facility. [See CDMO profile]

Related Information

Let MAI CDMO Help You Find the Right Sterile BFS CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with the most experienced sterile BFS CDMO providers offering turnkey blow-fill-seal contract manufacturing. Whether you’re scaling a preservative-free therapy, launching a hospital-use product, or exploring unit-dose innovation, we’ll help you find a partner ready to deliver quality and compliance.

Ready to advance your sterile product with BFS technology? Contact us today and find your ideal CDMO partner.