Prednisolone Acetate Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Prednisolone Acetate 1% ophthalmic suspension — the gold standard anti-inflammatory eye drop for post-cataract surgery care and anterior segment inflammation.

Key Highlights

  • WHO-GMP
    Certified

  • Prednisolone Acetate 1%
    w/v Sterile Ophthalmic Solution

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

What We Manufacture

Prednisolone Acetate Eye Drops — specifications & clinical context

Product Specifications

Generic Name Prednisolone Acetate
Strength 1% 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

Prednisolone Acetate 1% is the most prescribed ophthalmic anti-inflammatory globally — the standard of care for post-cataract surgery inflammation management (every cataract patient is prescribed it post-operatively). Also used for anterior uveitis, iritis, episcleritis and other anterior segment inflammatory conditions. With cataract surgery volumes rising dramatically in India and developing countries, Prednisolone Acetate 1% eye drops represent one of the fastest-growing ophthalmic product categories.

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    WHY 9M INDIA

    How Prednisolone Acetate Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing process

      Prednisolone Acetate 1% is a micronised suspension — Prednisolone Acetate is insoluble in water, requiring micronisation to <5 micron particle size for ophthalmic use. Manufactured in sterile ophthalmic cleanroom with validated suspension preparation under Grade A conditions. Preservative system (BAK or preservative-free) validated for 28-day in-use stability after opening.

    • In-house QC — every batch

      Sterility · Bacterial endotoxins · Particle size (D50 <5 micron, D90 <10 micron) · Resuspendability · Assay by HPLC · pH · Uniformity of dosage · 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.

    Need Prednisolone Acetate Eye Drops manufactured under your brand?

    Share your pack size, volume and target market. We confirm ophthalmic suspension capability within 24 hours.

    • 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 Prednisolone Sodium Phosphate eye drops in 0.5% and 1% w/v strengths at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Prednisolone is the most widely used corticosteroid eye drop globally — essential in post-operative ophthalmic care, uveitis management and inflammatory eye disease. All batches are produced under classified cleanroom conditions with full sterility documentation.

    • 02

      Prednisolone 1% eye drops are the standard corticosteroid used for: post-operative inflammation after cataract surgery and other intraocular procedures, anterior uveitis management, allergic conjunctivitis with significant inflammatory component, episcleritis and scleritis, vernal keratoconjunctivitis, and sympathetic ophthalmia. The 0.5% strength is used for milder inflammatory conditions and in patients with higher steroid response risk.

    • 03

      Prednisolone 1% is the standard strength for significant intraocular inflammation — post-cataract surgery, uveitis and severe allergic eye disease. Prednisolone 0.5% is used for milder inflammatory conditions, for tapering at the end of a treatment course, and in patients at higher risk of steroid-induced intraocular pressure elevation. Both strengths are available from 9M India with the same complete GMP documentation.

    • 04

      Yes. Prednisolone Sodium Phosphate 1% eye drops are the most widely used post-operative anti- inflammatory agent after phacoemulsification (cataract surgery). The standard regimen is typically 4 times daily for 4 weeks post-surgery, tapering to twice daily for a further 2 weeks. Cataract surgery is performed at enormous volume globally — over 10 million procedures annually in India alone — making Prednisolone eye drops a consistently high-volume institutional procurement item.

    • 05

      Yes. Prednisolone eye drops are a core part of 9M India's institutional ophthalmic supply portfolio. We supply to hospital ophthalmic departments and government cataract surgery programmes. Large-volume institutional packaging with complete GMP documentation, CoPP and batch CoA is available. Please contact our export team with programme volume requirements.

    • 06

      Prolonged corticosteroid eye drop use carries risks including steroid-induced ocular hypertension (elevated IOP leading to secondary glaucoma), posterior subcapsular cataract formation, and reduced resistance to ocular infections. These are well-documented risks that ophthalmologists manage with regular IOP monitoring, appropriate duration of use and steroid selection. These risks are relevant for clinical prescribing — not for the supply or registration of the formulation.

    • 07

      Yes. 9M India manufactures Moxifloxacin + Prednisolone Acetate combination eye drops — combining broad-spectrum antibiotic cover with corticosteroid anti-inflammatory action in a single formulation. This combination is widely used post-operatively after cataract surgery and in bacterial keratitis with inflammatory component, simplifying the post-operative drop regimen.

    • 08

      Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch- wise CoA (sterility, particulate matter, pH, assay, preservative content), ICH Zone IVb stability data and CTD/ACTD dossiers on request. Prednisolone eye drops are one of our highest-volume export formulations with established dossiers for multiple markets.

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