Contact Us →Supply scope
The pen platform is ours. Needles and cartridges are sourced accessories, each carrying its own manufacturer's documentation. The three interfaces are verified against your project rather than assumed from a standard.
Direct answer
The pen injector platform is a Penacta-documented configuration. Pen needles and cartridges are sourced accessories: they are supplied with the documentation and registration of the manufacturers that produce them. We coordinate all three so a project can be quoted, sampled and shipped as one supply, and we keep the evidence for each part separate instead of presenting them as a single approval.
| Item | Origin and documentation |
|---|---|
| Pen injector platform | Penacta-documented configuration. You receive the configuration specification, with drawings released under an agreed confidentiality route. |
| Cartridge, 1.5 mL and 3 mL | Sourced container. Cartridge syringes fall within the manufacturing partner's documented device scope alongside pen injectors. Ready-to-use cartridges are supplied in 3.0 mL, with 1.0 mL and 2.0 mL in development, under a US FDA Drug Master File (DMF No. 42439) held by the cartridge maker. You receive the container drawing and the cartridge maker's certificate of analysis. |
| Pen needle | Sourced from a specialised needle manufacturer, because fine-gauge cannula, siliconisation and sterilisation are a different process from device assembly. You receive that manufacturer's registration and instructions for use. |
| Secondary packaging | Coordinated as a project item: artwork file, print proof and change control, separate from the functional configuration. |
A shared nominal volume and a standard needle interface are starting conditions, not proof that a specific needle, cartridge and pen work together. The cartridge dimensional stack-up, flange and cap geometry, stopper system and travel, and the needle interface are checked against the selected pen configuration for your project.
| Not included | Why |
|---|---|
| The drug | Filling, formulation and the drug registration belong to the marketing authorisation holder. We do not supply a filled device. |
| Universal compatibility | A standard interface does not establish that a particular needle, container and pen combination performs as intended. That is confirmed per project. |
| A single combined approval | Each part carries its own registration. A container certificate is not a pen approval, and a needle registration is not a compatibility statement. |
A quotation that covers the device, the container and the needle at the same time needs five facts: the pen platform and configuration; the cartridge drawing or specified container; the needle specification and labelling route; the sample, pilot and repeat quantities for each of the three items; and the market where the combination will be placed.
The cartridge supplier holds a US FDA Drug Master File for these containers (DMF No. 42439), and a manufacturing partner of ours separately holds two US FDA 510(k) clearances for pen injector devices. All three numbers are public records, so you can verify them during supplier qualification instead of taking our word for it.