Moxifloxacin Eye Drops Manufacturer in India

WHO-GMP certified sterile manufacturing of Moxifloxacin 0.5% ophthalmic solution — the broadest-spectrum fluoroquinolone eye drop for bacterial conjunctivitis, keratitis and post-surgical infection prophylaxis.

Key Highlights

  • WHO-GMP
    Certified

  • Moxifloxacin HCl 0.5%
    w/v Sterile Ophthalmic Solution

  • DCGI Approved
    Formulations

  • Contract Manufacturing
    · 3PM · Direct Supply

WHAT WE MANUFACTURE

Moxifloxacin Eye Drops — specifications & clinical context

Product Specifications

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

 

Clinical Context

Moxifloxacin 0.5% is the most prescribed ophthalmic antibiotic globally — preferred over older fluoroquinolones (Ciprofloxacin, Ofloxacin) due to the broadest antibacterial spectrum including gram-positive, gram-negative and atypical organisms. Used for bacterial conjunctivitis and pre/post-operative prophylaxis for cataract, corneal and retinal surgeries. Standard formulary item in ophthalmology units and cataract surgery programmes.

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    WHY 9M INDIA

    How Moxifloxacin Eye Drops is manufactured at 9M India

    • WHO-GMP certified manufacturing

      Moxifloxacin eye drops manufactured in dedicated sterile ophthalmic cleanroom — Grade A fill-finish under Class A laminar airflow with Grade B background. Aqueous solution prepared in WFI, pH adjusted to 6.8, sterile-filtered through 0.22 micron membrane, aseptically filled into LDPE dropper bottles. Preservative-free (Moxifloxacin is inherently bacteriostatic — no preservative required in multidose formulation at this concentration).

    • In-house QC — every batch

      Sterility · Bacterial endotoxins (<0.5 EU/mL) · pH (6.8±0.5) · Clarity and particulate matter · Assay by HPLC (95.0–105.0%) · Related substances · 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 Moxifloxacin Eye Drops manufactured under your brand?

    Share your volume and target market. We confirm ophthalmic manufacturing 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 Moxifloxacin 0.5% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Moxifloxacin is a fourth-generation fluoroquinolone antibiotic — the most broad-spectrum antibiotic eye drop currently available. All batches are produced in classified cleanrooms with aseptic fill-finish, 0.2 micron sterile filtration and compendial sterility testing.

    • 02

      Moxifloxacin is a fourth-generation fluoroquinolone with broader antibacterial spectrum than Ciprofloxacin (second-generation). Key advantages include: significantly better gram-positive coverage (including Streptococcus pneumoniae and Staphylococcus aureus), activity against atypical organisms, superior corneal penetration achieving higher intraocular concentrations, preserved activity against many Ciprofloxacin-resistant strains, and a preservative-free formulation that improves ocular tolerability.

    • 03

      Yes. The standard Moxifloxacin 0.5% ophthalmic solution is formulated without preservatives — a significant advantage over benzalkonium chloride-preserved alternatives. Preservative-free ophthalmic antibiotics reduce epithelial toxicity, are better tolerated in patients with pre-existing ocular surface disease, and are preferred for peri-operative use where repeated dosing is required without compromising the corneal epithelium.

    • 04

      Moxifloxacin 0.5% eye drops are used for bacterial conjunctivitis (pink eye), bacterial keratitis (corneal ulcer), blepharitis with conjunctival involvement, pre-operative and post-operative antibiotic prophylaxis in cataract and other intraocular surgeries, and dacryocystitis. Its broad-spectrum activity makes it the preferred first-line antibiotic eye drop in most hospital ophthalmology settings globally.

    • 05

      Yes. Moxifloxacin eye drops are widely used as peri-operative antibiotic prophylaxis for cataract surgery — one of the highest-volume surgical procedures globally. 9M India manufactures Moxifloxacin in 5ml and 10ml sterile bottles suitable for institutional surgical supply. Large-volume orders with institutional packaging and complete GMP documentation are available for hospital and government procurement.

    • 06

      Moxifloxacin 0.5% eye drops are available in 5ml and 10ml sterile multi-dose bottles. Institutional bulk packaging for hospital and government programme supply can be arranged. Custom private label packaging with multilingual labelling for export markets is also available. Please contact our export team for specific packaging and labelling requirements.

    • 07

      Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, Certificate of Pharmaceutical Product (CoPP), batch-wise Certificate of Analysis (sterility, particulate matter, pH, assay, preservative content), ICH Zone IVb stability data and CTD/ACTD dossiers on request. Moxifloxacin eye drops are exported to 15+ countries across the Middle East, CIS, Africa and ASEAN.

    • 08

      Yes. 9M India manufactures Moxifloxacin + Prednisolone Acetate combination eye drops — combining the broad-spectrum antibiotic with a corticosteroid for conditions requiring simultaneous anti-infective and anti-inflammatory treatment. This combination is widely used post-operatively after cataract surgery and in bacterial keratitis with significant inflammatory component.

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