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Sterile bottles remain a preferred format for injectable drug products in hospitals and clinical environments due to their volume flexibility, safety, and scalability. Whether you need single- or multi-dose sterile solutions, partnering with expert sterile bottle CDMO companies ensures full aseptic integrity, regulatory compliance, and reliable supply.
Through complete aseptic bottle filling services, these CDMOs handle everything from formulation and filtration to sterile filling, labeling, and packaging — all under global GMP standards.
When selecting among sterile bottle CDMO companies, important criteria include:
Aseptic or terminal sterilization options depending on formulation
Container format support: glass or polymer bottles, screw cap, crimped, or IV-ready
Filling volume flexibility: typically from 5 mL to 500 mL
Batch size adaptability for clinical and commercial production
Compliance with ISO 5/Class 100 filling environments
Cold chain and storage capabilities for biologics or temperature-sensitive products
Strong regulatory history with FDA, EMA, PMDA, etc.
A capable CDMO should offer both sterile assurance and packaging flexibility tailored to injectable needs.
Top-tier aseptic bottle filling services include:
Sterile formulation and solution prep
Aseptic or terminal filling into glass or plastic bottles
Sterile filtration and container closure under GMP
Capping, sealing, and labeling with traceability
Visual inspection and container integrity testing (CCIT)
Multi-dose and preservative-free product support
Cold storage, logistics, and serialized packaging
Regulatory documentation and validation
These services are especially important for antibiotics, IV solutions, large-volume parenterals (LVPs), and hospital-use medications.
Working with experienced sterile bottle CDMO companies provides key benefits:
High-volume filling capacity for institutional and hospital supply
Unmatched sterility assurance through validated processes
Regulatory-ready systems and global compliance support
Flexible container options for different dosage needs
Faster time-to-market via integrated fill-finish solutions
This format is ideal for injectable drugs requiring accuracy, long shelf life, and ready integration into hospital workflows.
Some of the most trusted sterile bottle CDMO companies 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]
Liof Pharma: Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and sterile drugs. [See CDMO profile]
FAES FARMA: Developer and manufacturer of sterile products. [See CDMO profile]
Aenova: CDMO specialized in animal health products and sterile technologies. [See CDMO profile]
Ophtapharm (a Sentiss company): Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility. [See CDMO profile]
Steriles CDMO Companies | Steriles Contract Manufacturing Services
FDF CDMO Services | Finished Dosage Forms Contract Manufacturing
At MAI CDMO, we help pharma and biotech companies connect with leading sterile bottle CDMO companies offering complete aseptic bottle filling services. Whether you’re producing a hospital-based injectable or scaling a preservative-free multi-dose therapy, our network ensures you find the right partner — fast.
Looking for a sterile bottle filling solution tailored to your product? Contact us today and let’s get started.
If you have any questions or suggestions, click here. We will be happy to assist you.