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Injectable Bottle CDMO Companies
Sterile Bottle Filling Services

Your Trusted Partners for Injectable Bottles Contract Manufacturing and Development

Showing 26 facilities
FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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

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)

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)

USE: Human

BATCH SIZE: Large, Small, Medium

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

REGION: Europe

JAFRAL
Slovenia

JAFRAL

JAFRAL

Integrated biotechnology facility providing R&D, non-GMP and GMP manufacturing, QC testing, and fill & finish services for advanced biologics.

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

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

REGION: Europe

Aenova Group - Location Latina, Italy
Italy

Aenova Group - Location Latina, Italy

Aenova

Competence Center animal health products and sterile technologies.

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 |  Athens
Greece

Adragos Pharma | Athens

Adragos Pharma

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

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), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

SERVICES: Logistics, Development services, 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), 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

CATEGORY / PRODUCT: SERVICES, 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.

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.

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

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.

MARKETS: EMA (EU), FDA (USA)

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1

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

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

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

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.

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

Limited view

CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Solutions for non Viral Delivery programs

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Tubilux Pharma: registered office; manufacturing facility.

Location available after registration

Limited view

COSMETICS manufacturing site

MAI network supplier

Developer and manufacturer of new drug products with control realease technologies.

Location available after registration

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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

MARKETS: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)

USE: Human

BATCH SIZE: Large, Small, Medium

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

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

CONTROLLED SUBSTANCES: High potential for abuse & medical use

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

REGION: Europe

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Injectable bottles, whether multi-dose, bulk, or infusion-grade, require strict aseptic processing, accurate fill volumes, and robust container integrity. From small clinical batches to full commercial production, working with experienced injectable bottle CDMO companies ensures the sterility, consistency, and compliance essential for parenteral success.

With fully integrated sterile bottle filling services, these CDMOs support injectable drug products across a wide range of therapeutic categories, offering flexibility in batch size, fill volume, and packaging design.

How to Choose Injectable Bottle CDMO Companies

When selecting among injectable bottle CDMO companies, look for:

  • Aseptic filling expertise using RABS, isolators, or cleanroom environments
  • Compatibility with bottle types: glass, plastic (polymer), screw-cap or crimped
  • Support for various fill volumes (5 mL to 500 mL or more)
  • Terminal sterilization or true aseptic processes
  • Multi-dose or preservative-free filling experience
  • Batch size flexibility for clinical or commercial needs
  • Regulatory readiness with GMP certification and audit history

A strong CDMO ensures container integrity, dose accuracy, and full regulatory alignment from day one.

Key Services Offered by Sterile Bottle Filling Services Providers

Top-tier providers of sterile bottle filling services typically offer:

  • Sterile formulation and filtration of injectable solutions
  • Glass and plastic bottle filling with automated or semi-automated lines
  • Terminal sterilization or aseptic filling options
  • Preservative-free and multi-dose formulations
  • Capping, sealing, labeling, and visual inspection
  • Container closure integrity testing (CCIT)
  • Cold chain management for temperature-sensitive products
  • Regulatory and CMC support for global submissions

These services are ideal for hospital-use injectables, vaccines, antibiotics, biologics, and more.

Advantages of Partnering with Injectable Bottle CDMO Companies

Working with reliable injectable bottle CDMO companies provides multiple advantages:

  • High-capacity production for hospital and institutional supply
  • Reduced contamination risk through advanced aseptic technologies
  • Regulatory compliance with global GMP standards
  • Flexibility in container size and configuration
  • Faster time to market via integrated formulation, filling, and packaging

Bottled injectables remain a trusted format — and the right CDMO ensures their quality and reliability.

Injectable Bottle CDMO Companies

Some of the leading injectable bottle CDMO companies include:

  • Huiyu Pharma: Specialized in CMO/CDMO services for APIs and complex injectables, including implants, liposomes, high-potency, oncology, cytotoxic, and corticosteroid drugs. US FDA and EU EMA approved. [See CDMO profile]
  • Grifols: Sterile manufacturing solutions (small molecules) in flexible bags and vials. [See CDMO profile]
  • Cenexi: Production of sterile highly potent injectables, mainly against cancer. [See CDMO profile]
  • CDM Lavoisier: Manufacturing of glass ampoules, glass vials, and plastic (BFS) ampoules. [See CDMO profile]
  • Aenova: Sterile bottle filling CDMO. [See CDMO profile]
  • VIVUNT PHARMA: Sterile oncology drugs in bottles. [See CDMO profile]
  • Reig Jofre: Betalactam antibiotics (FDF) development and manufacturing with state-of-the-art facilities. [See CDMO profile]
  • PHARMALOOP S.L: Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multi-dose, non-sterile multi-dose, sachets, capsules, and tablets. [See CDMO profile]
  • Liof Pharma S.L.U: Trusted CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]
  • i+Med: Developer and manufacturer of new drug products utilizing controlled-release technologies. [See CDMO profile]
  • Ophtapharm: Ophthalmic & otic products — solutions, suspensions, emulsions, ointments, and gels. FDA-approved facility. [See CDMO profile]
  • Adragos Pharma: Focused on the development of value-added medicines; recently upgraded with HPAPI capabilities. [See CDMO profile]
  • Content Group: Sterile dosage forms (ophthalmic, nasal, otic) and finished drug product manufacturing. [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]
  • Ascendia Pharmaceutical Solutions: GMP-certified CDMO providing advanced sterile and non-sterile pharmaceutical manufacturing, formulation development, and analytical testing services. [See CDMO profile]
  • FAES FARMA: Developer and manufacturer of human medicinal products, offering end-to-end pharmaceutical development and production capabilities. [See CDMO profile]
  • Demo facility: Specialised in tissue therapy, cell therapy, and gene therapy (GTMP), supporting advanced therapeutic development and manufacturing activities. [See CDMO profile]

Related Information

Let MAI CDMO Network Help You Find the Right Injectable Bottle CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with top-tier injectable bottle CDMO companies offering full-service sterile bottle filling services. Whether you’re launching a hospital-based injectable, scaling a biologic, or working on preservative-free multi-dose delivery, we’ll help you find the partner with the right infrastructure and expertise.

Looking for a sterile bottle filling solution? Contact us today to find your ideal CDMO partner.