Timolol Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Timolol Maleate ophthalmic solution — 0.25% and 0.5% — a beta-adrenergic blocker for IOP reduction in open-angle glaucoma and ocular hypertension.

Key Highlights

  • WHO-GMP
    Certified

  • Timolol Maleate 0.25% · 0.5%
    w/v Sterile Ophthalmic Solution

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

What We Manufacture

Timolol Eye Drops — specifications & clinical context

Product Specifications

Generic Name Timolol Maleate
Strength 0.25% w/v · 0.5% w/v
Dosage Form Sterile Ophthalmic Solution (Eye Drops)
Route Topical Ophthalmic (Twice Daily)
Pack Size 5mL – 10mL
Packaging LDPE dropper bottle
Storage Store below 25°C · Protect from light 
Shelf Life 24 months
Manufacturing WHO-GMP Certified · Birkoni, Chhattisgarh · DCGI Approved · Manufacturing Licence Held
Regulatory Status DCGI Approved · Manufacturing Licence Held

Clinical Context

Timolol is the oldest ophthalmic beta-blocker and remains one of the most prescribed antiglaucoma eye drops globally — on the WHO Essential Medicines List. Despite newer prostaglandin analogues being more effective, Timolol remains widely used due to its lower cost, established safety profile and combination availability (Timolol + Dorzolamide, Timolol + Latanoprost). Very high government formulary and tender procurement volume.

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    WHY 9M INDIA

    How Timolol Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing process

      Timolol Maleate eye drops manufactured as aqueous solution in sterile ophthalmic cleanroom — pH adjusted to 6.5–7.5 for stability and comfort, BAK preservative system, sterile-filtered, aseptically filled. Gel-forming formulation (Timolol GFS) also available using gellan gum system for once-daily dosing — requires specialised viscous solution filling capability.

    • In-house QC — every batch

      Sterility · Bacterial endotoxins · pH (6.5–7.5) · 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.

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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 Timolol Maleate eye drops in 0.25% and 0.5% w/v strengths at its WHO- GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Timolol is a WHO Essential Medicine and the most widely used beta-blocker eye drop for glaucoma management globally. All batches are produced under classified cleanroom conditions with aseptic fill-finish and complete batch documentation.

    • 02

      Yes. Timolol is listed on the WHO Model List of Essential Medicines for the management of glaucoma and ocular hypertension. This designation drives substantial institutional and government procurement demand globally — particularly in national blindness prevention programmes across Africa, South Asia and the Middle East where glaucoma is a leading cause of preventable irreversible blindness. 9M India manufactures Timolol at scale for this institutional demand.

    • 03

      Timolol is a non-selective beta-adrenergic blocker that reduces aqueous humour production by the ciliary body epithelium — the primary mechanism for lowering intraocular pressure (IOP). It reduces IOP by approximately 25–30% from baseline, achieving maximal effect within 1–2 hours and sustained IOP reduction over 24 hours with twice-daily dosing. It remains one of the most cost-effective IOP-lowering agents available.

    • 04

      Timolol 0.25% is the starting dose used in patients who may be sensitive to beta-blockade — including elderly patients, those with mild respiratory conditions and first-time users. Timolol 0.5% is the standard therapeutic dose providing greater IOP reduction for patients requiring more aggressive pressure control. Both strengths are available from 9M India and many prescribers start with 0.25% before stepping up to 0.5% if needed.

    • 05

      Timolol eye drops are contraindicated in patients with asthma, severe COPD, sinus bradycardia, second or third degree AV block, and overt heart failure — due to systemic absorption of the beta-blocker through the nasolacrimal drainage system. Nasolacrimal occlusion (pressing the inner corner of the eye after instillation) reduces systemic absorption significantly. These are clinical prescribing considerations — relevant context for market positioning and patient information materials.

    • 06

      Yes. 9M India manufactures Timolol in combination with Dorzolamide (Timolol + Dorzolamide — beta- blocker + carbonic anhydrase inhibitor), Brimonidine (Timolol + Brimonidine — beta-blocker + alpha-2 agonist) and Latanoprost (Timolol + Latanoprost — beta-blocker + prostaglandin analogue). Fixed-dose combination antiglaucoma eye drops improve compliance by reducing the number of daily drops for patients on multiple glaucoma medications.

    • 07

      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. As a WHO Essential Medicine, Timolol eye drops are among our most established export formulations with dossiers available for multiple markets across the Middle East, Africa, CIS and ASEAN.

    • 08

      Timolol maleate is available in standard ophthalmic solution (0.25% and 0.5%) and as a gel-forming solution (Timolol GFS 0.1%) from 9M India. The gel-forming formulation gels on contact with the tear film, providing sustained drug release and once-daily dosing — improving compliance. Please contact our team for availability and specifications of the gel-forming formulation.

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