Dorzolamide Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Dorzolamide Hydrochloride 2% ophthalmic solution — a carbonic anhydrase inhibitor for IOP reduction in open-angle glaucoma and ocular hypertension.

Key Highlights

  • WHO-GMP
    Certified

  • Dorzolamide HCl 2%
    w/v Sterile Ophthalmic Solution

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

What We Manufacture

Dorzolamide Eye Drops — specifications & clinical context

Product Specifications

Generic Name Dorzolamide Hydrochloride
Strength 2% w/v
Dosage Form Sterile Ophthalmic Solution (Eye Drops)
Route Topical Ophthalmic (2–3 times daily)
Pack Size 5mL – 10mL
Packaging LDPE dropper bottle
Storage Store below 30°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

Dorzolamide 2% is a carbonic anhydrase inhibitor for glaucoma management — used as adjunct therapy when prostaglandin analogues or beta-blockers alone are insufficient. Also widely used in the fixed-dose combination with Timolol (Dorzolamide 2% + Timolol 0.5%) — one of the most prescribed antiglaucoma combinations. Chronic daily use for glaucoma patients.

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    WHY 9M INDIA

    How Dorzolamide Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing process

      Dorzolamide solution manufactured in sterile ophthalmic cleanroom — pH adjusted to 5.5–5.8, BAK preservative, sterile-filtered, aseptically filled. Dorzolamide + Timolol combination eye drops also manufactured — requiring validated compatibility study confirming both actives are stable in the same ophthalmic solution.

    • In-house QC — every batch

      Sterility · Bacterial endotoxins · pH (5.5–5.8) · 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.

    Need Dorzolamide Eye Drops manufactured under your brand?

    Share your requirement (single or combination with Timolol), volume and market. We confirm 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 Dorzolamide Hydrochloride 2% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Dorzolamide is a topical carbonic anhydrase inhibitor (CAI) used as monotherapy or adjunct antiglaucoma treatment. All batches are produced under classified cleanroom conditions with complete sterility documentation and regulatory support.

    • 02

      Dorzolamide inhibits carbonic anhydrase II (CA-II) in the ciliary body epithelium — an enzyme essential for bicarbonate ion production in aqueous humour formation. By blocking CA-II, Dorzolamide reduces aqueous humour production and consequently lowers intraocular pressure by approximately 15–20% as monotherapy. When combined with Timolol, the two complementary mechanisms of aqueous suppression provide additive IOP reduction of 25–35%.

    • 03

      Dorzolamide is preferred over or used alongside Timolol in: patients with asthma, severe COPD or significant bradycardia where systemic beta-blockade from Timolol is contraindicated, patients requiring additional IOP lowering beyond what Timolol alone achieves, and patients who develop intolerance to beta-blocker eye drops. Dorzolamide can be used safely in these populations as its systemic absorption does not affect cardiac or respiratory function significantly.

    • 04

      Yes. 9M India manufactures Dorzolamide 2% + Timolol 0.5% fixed-dose combination eye drops — one of the most widely prescribed antiglaucoma combinations globally. This combination provides complementary dual aqueous suppression (CAI + beta-blocker) with twice-daily dosing, significantly improving compliance compared to using the two agents separately at different times.

    • 05

      Dorzolamide 2% as monotherapy is dosed three times daily (morning, midday, evening). When used in combination with Timolol as a fixed-dose formulation (Dorzolamide + Timolol), dosing is reduced to twice daily — the primary compliance advantage of the fixed-dose combination. Patients with sulphonamide allergy should be screened before prescribing as Dorzolamide is a sulphonamide derivative.

    • 06

      Yes. Dorzolamide is frequently added as third-line therapy in patients on Latanoprost + Timolol who require additional IOP lowering — or as a Timolol-free alternative in beta-blocker contraindicated patients already on Latanoprost. The combination of a prostaglandin analogue (Latanoprost) + CAI (Dorzolamide) provides effective dual therapy without systemic beta-blockade risk.

    • 07

      9M India exports Dorzolamide eye drops to Phase 1 markets including the UAE, Iraq, Egypt, Kazakhstan, Sri Lanka and others across the Middle East, CIS, Africa and ASEAN. Dorzolamide — both as monotherapy and in combination with Timolol — is in growing demand in these markets as glaucoma treatment protocols increasingly move toward combination therapy for better IOP control and compliance.

    • 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 for Dorzolamide 2% monotherapy and Dorzolamide + Timolol fixed-dose combination eye drops.

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