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At 9M India Limited, trust through quality, transparency, performance.
What We Manufacture

| Generic Name | Ketorolac Tromethamine |
| Strength | 0.4% w/v · 0.5% w/v |
| Dosage Form | Sterile Ophthalmic Solution (Eye Drops) |
| Route | Topical Ophthalmic |
| Pack Size | 5mL – 10mL |
| Packaging | LDPE dropper bottle |
| Storage | Store below 25°C · Protect from light · Shake before use |
| Shelf Life | 24 months |
| Manufacturing | WHO-GMP Certified · Birkoni, Chhattisgarh · DCGI Approved · Manufacturing Licence Held |
| Regulatory Status | DCGI Approved · Manufacturing Licence Held |
Ketorolac ophthalmic is the most prescribed NSAID eye drop — used post-cataract surgery for pain and inflammation management, often as an alternative or complement to corticosteroid eye drops. Also used for seasonal allergic conjunctivitis and cystoid macular oedema prevention. Standard formulary item in cataract surgery programmes.
WHY 9M INDIA
Ketorolac Tromethamine ophthalmic solution manufactured in sterile cleanroom — pH adjusted to 7.4 for ocular compatibility, BAK preservative system, sterile-filtered, aseptically filled. Shelf-life stability confirmed with degradation protection from light-protective secondary packaging.
Sterility · Bacterial endotoxins · pH (7.0–8.0) · Assay by HPLC · Related substances · BAK content · Clarity · Container closure integrity — all in-house.
Manufacturing Licence · DCGI approvals · WHO-GMP Certificate · COA · COC · Stability data — available within 24 hours for tender, export registration or CDMO requirements.
Share your concentration, volume and market. We confirm manufacturing capability within 24 hours.
WHO-GMP
Certified Facility
In-House QC
Contract &
3PM Available
DCGI
Approved
Our Eye Drops Range
Key molecules from our injectable manufacturing portfolio — across all five therapeutic categories, three container formats and the full spectrum of institutional and export supply requirements.
Moxifloxacin Eye Drops | Anti-infective | Antibiotic | 5ml/10ml
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Ciprofloxacin Eye Drops | Anti-infective | Antibiotic | 5ml/10ml
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Natamycin Eye Drops | Anti-infective | Antifungal | 5ml
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Prednisolone Eye Drops | Anti-inflammatory | Corticosteroid | 5ml/10ml
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Olopatadine Eye Drops | Anti-allergic | Antihistamine | 5ml
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Timolol Eye Drops | Antiglaucoma | Beta-blocker | 5ml
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Latanoprost Eye Drops | Antiglaucoma | Prostaglandin analogue | 2.5ml (cold chain)
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Dorzolamide Eye Drops | Antiglaucoma | CAI | 5ml
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CMC Eye Drops | Lubricant | Artificial tears | 10ml/15ml
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Cyclosporine Eye Drops | Immunomodulator | Dry eye treatment | 3ml vials
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Tropicamide Eye Drops | Mydriatic | Cycloplegic | 5ml
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We keep answer short
Find answers to the most common questions about our products, services, pricing, and policies.
01
Yes. 9M India manufactures Ketorolac Tromethamine 0.4% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Ketorolac is an NSAID (non-steroidal anti-inflammatory drug) eye drop widely used for post-operative pain and inflammation after cataract surgery, seasonal allergic conjunctivitis and cystoid macular oedema prevention.
02
Ketorolac 0.4% ophthalmic NSAID eye drops are indicated for: relief of ocular itching due to seasonal allergic conjunctivitis, post-operative pain and inflammation following cataract extraction, prevention of intraoperative miosis (pupil constriction) during surgery, and reduction of cystoid macular oedema (CMO) risk post-cataract surgery. They are increasingly used alongside or instead of corticosteroid eye drops where steroid side effects are a concern.
03
NSAID eye drops like Ketorolac carry no risk of steroid-induced intraocular pressure elevation, posterior subcapsular cataract formation or increased susceptibility to infection — side effects associated with prolonged corticosteroid use. Ketorolac is preferred for longer-term anti-inflammatory use, in patients with glaucoma or steroid responders, and for prevention of CMO post-cataract surgery where a prolonged anti-inflammatory course is beneficial.
04
Yes. Ketorolac 0.4% eye drops are widely used in the peri-operative management of cataract surgery: pre-operatively (3 doses in the hour before surgery) to prevent intraoperative miosis and reduce prostaglandin-mediated pupil constriction, intraoperatively as supplemental irrigating solution in some protocols, and post-operatively for 2–4 weeks to prevent CMO and manage post-surgical pain and inflammation.
05
Yes. Combined use of a corticosteroid eye drop (Prednisolone) and an NSAID eye drop (Ketorolac) post- cataract surgery is the standard dual anti-inflammatory protocol in most ophthalmic surgery centres globally. The two agents work through different anti-inflammatory pathways and their combination provides more complete inflammation control with a lower steroid dose requirement — reducing steroid side effect risk.
06
Ketorolac 0.4% ophthalmic solution is available in 5ml sterile multi-dose bottles. Institutional packaging for hospital surgical programmes and custom private label export packaging are available. Please contact our export team for volume-specific pricing and packaging requirements.
07
Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch- wise CoA (sterility, particulate matter, pH, assay), ICH Zone IVb stability data and CTD/ACTD dossiers on request. Ketorolac eye drops are part of 9M India's active ophthalmic export portfolio for the Middle East, CIS, Africa and ASEAN markets.
08
Ketorolac ophthalmic NSAID demand is highest in markets with high cataract surgery volume — which includes all of 9M India's Phase 1 export markets. Cataract blindness burden is highest in South Asia, Africa and the Middle East, driving large-scale cataract surgical programmes in which Ketorolac is a standard peri-operative component. Institutional and government programme supply represents the primary demand channel.