Nasal Spray Contract Manufacturing
Metered-dose nasal sprays, nasal drops and saline sprays made under your brand by GMP-licensed manufacturers in India.
In a nasal spray, the pump is part of the product
With a tablet, the formula is the product. With a nasal spray, the pump and actuator matter as much as the liquid: they decide the droplet size, how much drug each spray delivers and how the spray reaches the nose. Two sprays with the same formula can perform differently with different pumps.
That is why regulators ask for spray characterisation data as well as a Certificate of Analysis: droplet size distribution, spray pattern, plume geometry, dose per spray and priming. For generic nasal sprays in the US, the FDA's product-specific guidances set out which laboratory tests are needed to show bioequivalence, and for some suspension sprays they may also call for pharmacokinetic or clinical studies.
Nasal sprays are filled and crimped on specialised lines with validated pumps, so only some formulation plants offer them. We shortlist from those.
Tell us this to get a quote
- Molecule(s) and dose per spray
- Solution or suspension
- Preserved or preservative-free
- Number of sprays per bottle
- Target market(s)
- Bottle, pump and pack
- Annual volume and first-order quantity
- Your own formula and dossier, or the manufacturer's
What to check in a nasal spray manufacturer
Pump and actuator
Ask which pump is used, who supplies it and what documentation the supplier provides. Changing the pump after registration usually needs new data and a variation.
Spray characterisation
Droplet size distribution, spray pattern, plume geometry and dose per spray, tested with the registered pump at the start and end of shelf life.
Preservative or preservative-free
Many multi-dose sprays contain benzalkonium chloride. Preservative-free sprays need pumps designed to keep microbes out, and more microbial testing.
Approvals for your market
WHO-GMP and a CoPP for most emerging markets; for regulated markets, GMP evidence your regulator accepts, such as an EU GMP certificate, a US FDA inspection, or MHRA or TGA clearance.
Stability in the device
Stability tested in the final bottle and pump, stored upright and inverted, with in-use testing across the number of sprays on the label.
Dose uniformity
For suspension sprays such as fluticasone or mometasone, check that the dose stays uniform from the first spray to the last after shaking.
Common nasal spray products
| Product type | Examples | Watch for |
|---|---|---|
| Corticosteroid suspension | Fluticasone propionate, mometasone furoate, budesonide; azelastine with fluticasone | Dose uniformity, particle size, bioequivalence data |
| Antihistamine solution | Azelastine, olopatadine | Taste, spray characterisation |
| Decongestant solution | Oxymetazoline, xylometazoline | Preservative, separate children's strengths |
| Systemic or emergency use | Sumatriptan, naloxone, desmopressin | Often single-dose devices (sumatriptan, naloxone); higher regulatory bar |
| Saline and seawater sprays | Isotonic and hypertonic saline | May be a medical device rather than a medicine in some markets |
Requirements for generic nasal sprays differ between markets. We check what your regulator expects before you commit to a site.
How it works with PharmaTradz
You send the product, form, market and volume.
Two or three plants that already make that form, with their approvals and country of manufacture. Names under a confidential disclosure agreement when the requirement is firm.
Samples of an existing product, or development and stability batches with the chosen pump for a new one, including spray characterisation.
Your brand, artwork and pack, and the dossier or product file your market needs.
Production and release with a batch-wise Certificate of Analysis and spray test results. Third-party pre-shipment inspection on request.
Scheduled batches with the same site, materials and documents.
Problems we see most often
Pump changed after registration
A cheaper or unavailable pump is swapped in, and spray performance no longer matches the registered data. Fix the pump in the supply agreement.
Clogging and uneven sprays
Crystals form at the tip or a suspension settles, so sprays become weak or irregular. Ask for in-use test results across the full number of sprays.
Damage in transit
Actuators crack or bottles leak in air freight. Check the closure, the protective cap and the shipper, not just the liquid.
Have a nasal spray product in mind?
Send the molecule, dose per spray, market and annual volume. We will tell you which manufacturers fit and what data they hold.
Send your requirement Talk to our teamOther contract manufacturing
Also: lyophilisation, prefilled syringes, ophthalmic products and small batches. Building your own brand across several products? See white label and third-party manufacturing, or the CDMO and contract manufacturing guide hub.
