Ketorolac Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Ketorolac Tromethamine ophthalmic solution — 0.4% and 0.5% — an NSAID eye drop for post-cataract pain and inflammation, seasonal allergic conjunctivitis.

Key Highlights

  • WHO-GMP
    Certified

  • Ketorolac Tromethamine 0.4% · 0.5%
    w/v Sterile Ophthalmic Solution

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

What We Manufacture

Ketorolac Eye Drops — specifications & clinical context

Product Specifications

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

Clinical Context

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.

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    WHY 9M INDIA

    How Ketorolac Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing process

      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.

    • In-house QC — every batch

      Sterility · Bacterial endotoxins · pH (7.0–8.0) · Assay by HPLC · Related substances · BAK content · Clarity · Container closure integrity — all in-house.

    • Documentation within 24 hours

      Manufacturing Licence · DCGI approvals · WHO-GMP Certificate · COA · COC · Stability data — available within 24 hours for tender, export registration or CDMO requirements.

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    • WHO-GMP
      Certified Facility

    • In-House QC

    • Contract &
      3PM Available

    • DCGI
      Approved

    We keep answer short

    Frequently Asked Questions

    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.

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