0.5% Moxifloxacin Hydrochloride Eye Drops 10mL | Advanced Fluoroquinolone Antibiotic

0.5% Moxifloxacin Hydrochloride Eye Drops 10mL: What the Published Guidance Says

Fifteen ophthalmic products spanning anti-infective, anti-allergic, anti-inflammatory, antiviral and ocular-surface categories — including the two anti-infectives the WHO Model List names for conjunctivitis and infectious keratitis.

0.5% Moxifloxacin Hydrochloride Eye Drops 10mL sits in the Ophthalmic range. The notes below are the ones that most often change a specification, a label or a tender submission.

• Trachoma and endophthalmitis have separate recommendations For trachoma the treatment of choice is a single oral dose of azithromycin, with topical azithromycin or tetracycline also indicated. For bacterial endophthalmitis, the listings for ceftazidime, ceftriaxone and vancomycin were extended to cover it as a first-choice option, with the Committee noting that intravitreal administration requires specialist training and adequate infrastructure. WHO eEML — Ofloxacin (ophthalmological)
• Ofloxacin 0.3% — for keratitis, and extended to conjunctivitis Ofloxacin eye drops 0.3% are listed for infectious keratitis, and in 2021 the Expert Committee recommended expanding the indication to include conjunctivitis. Topical fluoroquinolones are the class the Committee endorsed for infectious keratitis. WHO eEML — Ofloxacin (ophthalmological)
• Evidence for conjunctivitis does not favour one antibiotic over another The Committee noted that topical antibiotics are indicated for moderate to severe infection and can be considered in mild cases, but that available evidence does not make it possible to identify specific, preferred antibiotics for conjunctivitis. It therefore endorsed the existing gentamicin and tetracycline listings rather than picking a winner. WHO eEML — Ofloxacin (ophthalmological)

We quote these sources rather than paraphrase them loosely, because the detail matters commercially for 0.5% Moxifloxacin Hydrochloride Eye Drops 10mL. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

0.5% Moxifloxacin Hydrochloride Eye Drops 10mL — Supply Parameters

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: 0.1% Dexamethasone Sodium Phosphate Eye Drops 10mL, 5% Taurine Eye Drops 10mL, 1% Acyclovir Eye Drops 10mL, 0.5% Chloramphenicol Eye Drops 10mL, 0.3% Gentamicin Eye Drops 10mL, 0.5% Hypromellose Eye Drops 10mL, 0.5% Kanamycin Eye Drops 10mL, 2.5% Lincomycin Hydrochloride Eye Drops 10mL.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Every batch of 0.5% Moxifloxacin Hydrochloride Eye Drops 10mL is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

• Testing for heavy metals and elemental impurities
• Testing for packaging integrity and seal testing
• Testing for description and identification
• Testing for assay of the active substance
• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

• Pack size: Sterile multi-dose dropper bottle (10mL) with tamper-evident seal. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store at room temperature (15°C-25°C), protected from light. Keep container tightly closed. Do not freeze. Discard within 4 weeks of first opening..
• Shelf life: 24 months unopened; discard within 4 weeks of first opening. Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Documents for 0.5% Moxifloxacin Hydrochloride Eye Drops 10mL are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.

• CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
• Site Master File and GMP certificate for the manufacturing workshops.
• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

The context for 0.5% Moxifloxacin Hydrochloride Eye Drops 10mL is its place among ophthalmic preparations used in WHO and MSF eye-care protocols. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.

Related Ophthalmic Products

• 0.1% Dexamethasone Sodium Phosphate Eye Drops 10mL — 10mL
• 5% Taurine Eye Drops 10mL — 10mL
• 1% Acyclovir Eye Drops 10mL — 10mL
• 0.5% Chloramphenicol Eye Drops 10mL — 10mL
• 0.3% Gentamicin Eye Drops 10mL — 10mL
• 0.5% Hypromellose Eye Drops 10mL — 10mL

Browse the full Ophthalmic range; all Ophthalmic; the complete product catalogue.