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Glass ampoules remain a gold standard for sterile injectable products, offering tamper-evident packaging, excellent chemical stability, and full protection from contamination. Whether you´re developing high-purity injectable solutions or single-dose formulations, partnering with experienced ampoule filling CDMO companies ensures precise filling, clean sealing, and global regulatory compliance.
Through integrated filling services, these CDMOs support full lifecycle development and commercial production of ampoule-based drug products — from early-stage batches to large-scale GMP supply.
When selecting among ampoule filling CDMO companies, key considerations include:
Compatibility with ampoule types: flame-sealed, scored, break ring, or OPC (one-point cut)
Aseptic and terminal sterilization capabilities
Support for various fill volumes (typically 1 mL to 25 mL)
Speed and automation level of ampoule filling and sealing lines
Cleanroom environment standards (ISO 5/Class 100)
Proven regulatory track record: FDA, EMA, PMDA, etc.
Inspection, labeling, and packaging capabilities under GMP
A qualified ampoule CDMO ensures high-volume precision, sterility, and full documentation from batch to batch.
Leading injectable ampoules manufacturing providers typically offer:
Sterile formulation and filtration
Automated ampoule filling and flame sealing
Glass ampoule sourcing and customization
Aseptic or terminal sterilization (depending on formulation)
Visual inspection (manual or automated)
Labeling, cartoning, and serialization
Container closure integrity testing (CCIT)
Cold chain storage, if applicable
Regulatory and QA documentation for submissions and audits
These services support sterile injectables in oncology, emergency medicine, ophthalmology, and more.
Collaborating with expert ampoules manufacturing CDMO companies offers multiple benefits:
High chemical stability thanks to inert glass containers
Full sterility assurance via flame-sealed, tamper-evident packaging
Reduced risk of contamination and interaction with external environments
Fast production cycles with high-speed filling lines
Strong global acceptance of ampoules for regulatory submissions
Ampoules are ideal for single-dose injectable drugs requiring safety, purity, and long-term storage.
Some of the most trusted ampoule filling CDMO companies include:
Cenexi: GMP plant on a four-hectare site located 9 km east of Paris. It is a center of excellence for injectable ampoules. [See CDMO profile]
CDM Lavoisier: CDMO specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules. [See CDMO profile]
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At MAI CDMO, we connect pharma and biotech companies with experienced ampoules CDMO companies offering complete injectable ampoule manufacturing solutions. From early development to commercial-scale production, we help you find a sterile manufacturing partner that meets your product’s technical, regulatory, and operational needs.
Ready to launch or scale your ampoule-based injectable? Contact us today and find your ideal CDMO.
If you have any questions or suggestions, click here. We will be happy to assist you.