Latanoprost Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Latanoprost 0.005% ophthalmic solution — the most effective single-agent IOP-lowering eye drop for open-angle glaucoma and ocular hypertension. Requires cold-chain storage (2–8°C).

Key Highlights

  • WHO-GMP
    Certified

  • Latanoprost 0.005% w/v (50 mcg/mL)
    Sterile Ophthalmic Solution · Cold Chain

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

What We Manufacture

Latanoprost Eye Drops — specifications & clinical context

Product Specifications

Generic Name  Latanoprost
Strength  0.005% w/v (50 mcg/mL)
Dosage Form Sterile Ophthalmic Solution (Eye Drops)
Route Topical Ophthalmic (once daily, evening)
Pack Size 5mL – 10mL
Packaging LDPE dropper bottle (refrigerated cold-chain packaging)
Storage Store at 2–8°C (refrigerated) before opening · After opening: stable up to 6 weeks at ≤25°C · Protect from light
Shelf Life 24 months refrigerated
Manufacturing WHO-GMP Certified · Birkoni, Chhattisgarh · DCGI Approved · Manufacturing Licence Held
Regulatory Status DCGI Approved · Manufacturing Licence Held

Clinical Context

Latanoprost is the most effective first-line IOP-lowering drug for open-angle glaucoma — reducing IOP by 27–35% with once-daily evening dosing. On the WHO Essential Medicines List. Glaucoma affects approximately 70 million people worldwide and is the leading cause of irreversible blindness. Latanoprost is prescribed to millions of patients globally as first-line therapy — chronically, for life. Cold-chain requirement (2–8°C) adds complexity but 9M India’s ophthalmic manufacturing includes validated cold-chain fill-finish capability.

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    WHY 9M INDIA

    How Latanoprost Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing process

      Latanoprost 0.005% solution manufactured in sterile ophthalmic cleanroom under strict temperature control — Latanoprost degrades rapidly above 25°C. Aqueous solution prepared at controlled temperature in WFI with BAK preservative system, sterile-filtered, aseptically filled into LDPE bottles, immediately sealed and transferred to refrigerated cold storage. Cold-chain distribution from 9M India facility to distributor required.

    • In-house QC — every batch

      Sterility · Bacterial endotoxins · pH (6.7–7.7) · Assay by HPLC (95.0–105.0%) · Related substances (latanoprost acid) · Clarity · BAK content · Container closure integrity — all in-house. Refrigerated stability data per ICH Q1A.

    • Documentation within 24 hours

      Manufacturing Licence · DCGI approvals · WHO-GMP Certificate · COA · COC · Stability data — available within 24 hours.

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    Share your volume and cold-chain distribution capability. We confirm Latanoprost manufacturing and cold-chain logistics 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 Latanoprost 0.005% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Latanoprost is a prostaglandin F2-alpha analogue and the most prescribed once-daily antiglaucoma eye drop globally. Manufacturing includes cold chain management (2–8°C pre-opening), documented temperature monitoring and full sterility testing on every batch.

    • 02

      Latanoprost 0.005% offers the highest IOP-lowering efficacy among all topical antiglaucoma agents — reducing IOP by 25–35% from baseline — combined with once-daily evening dosing (the most compliant regimen possible). It works by increasing uveoscleral aqueous outflow through the FP prostaglandin receptor, a different mechanism from beta-blockers, making it effective even in patients where Timolol is insufficient or contraindicated.

    • 03

      Latanoprost 0.005% requires cold chain storage at 2–8°C (refrigerated) before opening. After opening, the bottle is stable at room temperature (below 25°C) for 4 weeks. 9M India manages cold chain manufacture, storage and dispatch with documented temperature monitoring records for every batch and shipment. Cold chain documentation is provided as part of the batch CoA and export documentation package.

    • 04

      Latanoprost has a distinctive and well-documented side effect profile from its prostaglandin mechanism: iris colour change (increased brown pigmentation — particularly in hazel/green eyes), eyelash growth and darkening (hypertrichosis), periorbital skin darkening, and deepening of the upper lid sulcus. These are permanent changes with long-term use. Prescribers inform patients — particularly those using drops in one eye only where asymmetry may be visible.

    • 05

      Latanoprost is first-line or adjunct therapy for open-angle glaucoma and ocular hypertension — the most common forms of glaucoma. It is particularly valuable as it can be used in patients with asthma or COPD where beta-blockers like Timolol are contraindicated. It is also used in normal tension glaucoma where IOP lowering beyond normal range has been shown to reduce progression. It is not the agent of choice for acute angle-closure glaucoma.

    • 06

      Yes. Latanoprost is increasingly included in national essential medicine lists and glaucoma management guidelines as first-line therapy. 9M India manufactures Latanoprost for institutional and government programme supply with full cold chain documentation, CoPP and batch CoA. Please contact our export team with programme volume and cold chain infrastructure requirements.

    • 07

      Yes. 9M India manufactures Latanoprost 0.005% + Timolol 0.5% fixed-dose combination eye drops — combining the most effective prostaglandin analogue with the most established beta-blocker in a single once-daily formulation. This combination provides additive IOP lowering (typically 30–40% reduction) with maximum convenience for patients requiring dual therapy.

    • 08

      Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch- wise CoA (sterility, particulate matter, pH, assay, cold chain temperature records), ICH Zone IVb stability data (including cold chain stability), and CTD/ACTD dossiers on request. Cold chain documentation covering manufacture, storage and dispatch is included as standard for Latanoprost export.

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