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Pre-filled syringes (PFS) are one of the fastest-growing formats for injectable drug delivery, offering convenience, safety, and precise dosing for both healthcare professionals and patients. Whether you´re developing a biologic, biosimilar, or vaccine, working with experienced PFS CDMO companies ensures compliant, scalable, and sterile manufacturing.
With full-service pre-filled syringes contract manufacturing, these CDMOs provide formulation, aseptic fill-finish, device integration, and regulatory support — helping you bring high-quality injectable products to market efficiently.
When evaluating syringes CDMO companies, key considerations include:
Aseptic filling infrastructure: Isolators, RABS, and Grade A cleanrooms
Device compatibility: Luer-lock, staked-needle, safety syringes, autoinjectors
Filling flexibility: 0.2 mL to 5 mL, with viscosity-appropriate systems
Experience with biologics, vaccines, and high-value APIs
Cold chain and storage capabilities for temperature-sensitive drugs
Serialization, labeling, and secondary packaging
Regulatory track record with FDA, EMA, PMDA, and WHO
The right CDMO will align with your product’s complexity, scale, and market strategy.
Top-tier pre-filled syringes contract manufacturing providers typically offer:
Formulation development and viscosity adjustment
Aseptic syringe filling in glass or polymer containers
Device assembly (plunger, backstop, needle shield, safety system)
Container closure integrity testing (CCIT)
Automated visual inspection and fill weight verification
Stability studies and cold chain management
Regulatory documentation and batch record generation
Support for combination product filings (drug + device)
These services support products from Phase I to global commercial launch.
Choosing expert PFS manufacturing companies offers multiple advantages:
Improved patient compliance with ready-to-use formats
Reduced contamination risk via closed aseptic filling
Faster market readiness with integrated development and filling
High scalability for growing product demand
Compatibility with advanced delivery systems like autoinjectors and pen devices
PFS products meet modern healthcare expectations — your CDMO should too.
Some of the most recognized PFS CDMO companies include:
Huiyu Pharma: Company specialized in CMO/CDMO services for APIs and complex injectables, including implants, liposomes, high-potency, oncology, cytotoxic, and corticosteroid drugs. With US FDA and EU EMA approvals, we ensure top-tier quality and compliance. [See CDMO profile]
Cenexi: CDMO specialized in the production of sterile highly potent injectables, mainly against cancer. [See CDMO profile]
Aenova: Sterile bottle filling CDMO, including PFS. [See CDMO profile]
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Injectables CDMO Companies | Injectables Contract Manufacturing Services
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At MAI CDMO, we connect pharma and biotech companies with top-tier PFS CDMO companies offering comprehensive sterile injectable contract manufacturing solutions. Whether you´re producing a monoclonal antibody, vaccine, or specialty injectable, we’ll help you find the right partner for development, fill-finish, and regulatory success.
Ready to scale your injectable into a ready-to-use PFS format? Contact us today and find your ideal CDMO partner.
If you have any questions or suggestions, click here. We will be happy to assist you.