Ophthalmic Contract Manufacturing
Sterile eye drops, suspensions, gels and eye ointments made under your brand by GMP-licensed manufacturers in India.
Eye products must be sterile
All ophthalmic medicines, including eye drops, gels and eye ointments, must be sterile. That makes ophthalmic manufacturing much closer to injectable manufacturing than to ordinary liquids: clean rooms, sterile filtration or terminal sterilisation, aseptic filling and sterility testing.
The risk is real. In 2023 the US FDA told consumers to stop using artificial tears made by an Indian manufacturer, which were linked to an outbreak of extensively drug-resistant Pseudomonas aeruginosa in the US. Later that year the FDA warned against more than two dozen eye drops from another Indian plant. Evidence of sterility assurance is the first thing we ask each site for.
Beyond sterility, eye products need the right pH, osmolality and viscosity for comfort, a preservative or a preservative-free system for multi-dose bottles, and stable particle size for suspensions.
Tell us this to get a quote
- Molecule(s) and strength
- Form: solution, suspension, emulsion, gel or ointment
- Preserved, preservative-free multi-dose, or single-dose units
- Bottle size or unit-dose pack
- Target market(s)
- Annual volume and first-order quantity
- Storage: room temperature or refrigerated
What to check in an ophthalmic manufacturer
Sterility assurance
How the product is sterilised and filled, media fill results for the line, and sterility test results. Ask about recent regulatory inspections of the sterile area.
Preservative or preservative-free
Many multi-dose drops contain benzalkonium chloride, which can irritate with long-term use. Preservative-free products need special multi-dose bottles or single-dose units.
pH, osmolality and viscosity
These decide comfort and stability. Ask for the specifications and how they hold up over shelf life.
Particle size for suspensions
Suspensions such as prednisolone acetate need controlled particle size and must shake back evenly. Ask for re-dispersion and particle size data.
Bottle, tip and cap
The dropper tip sets the drop size, and the bottle material affects stability. Check the container specification and drop-size data.
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 or a US FDA inspection.
Which ophthalmic form fits the product?
| Form | Examples | Watch for |
|---|---|---|
| Solution | Timolol, moxifloxacin, latanoprost | Preservative; refrigeration for most latanoprost products before opening |
| Suspension | Prednisolone acetate, brinzolamide, loteprednol | Particle size, re-dispersion, dose uniformity |
| Emulsion | Cyclosporine | Droplet size, emulsion stability |
| Gel or ointment | Ganciclovir or carbomer gels; chloramphenicol and tobramycin eye ointments | Sterile semi-solid manufacture, tube integrity |
| Single-dose units | Preservative-free artificial tears and lubricants | Blow-fill-seal capacity, unit cost |
The same molecule can be made in more than one form. The right choice depends on stability, comfort and what your market already accepts.
How it works with PharmaTradz
You send the product, form, market and volume.
Two or three plants that already make that type of product, 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 for a new one, including preservative efficacy testing.
Your brand, artwork and pack, and the dossier your market needs.
Production and release with a batch-wise Certificate of Analysis and sterility results. Third-party pre-shipment inspection on request.
Scheduled batches with the same site, materials and documents.
Problems we see most often
Weak sterility controls
Eye products have been recalled for contamination. Do not choose a site on price alone; review its sterile operations and inspection history.
Suspension that will not re-disperse
Particles settle and cake, so doses vary. Ask for re-dispersion results at the end of shelf life.
Wrong drop size
A different dropper tip changes the dose per drop. Specify the bottle and tip in the specification.
Have an eye-care product in mind?
Send the molecule, form, pack, market and annual volume. We will tell you which manufacturers fit and what they hold.
Send your requirement Talk to our teamOther contract manufacturing
Building your own brand across several products? See white label and third-party manufacturing, or the CDMO and contract manufacturing guide hub.
