Introduction

Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Gentamicin Eye and Ear Drops as a sterile finished dosage formulation not APIto importers, distributors and institutional buyers across Africa, Southeast Asia and Latin America.

Our Gentamicin Sulphate 0.3% w/v ophthalmic and otic solutions are manufactured in a dedicated sterile block under validated aseptic conditions and filled into tamper-evident LDPE dropper bottles engineered to hold sterility, clarity and preservative efficacy through tropical-climate distribution.

Every consignment is backed by a complete CTD dossier also available in ACTD and eCTD format so your regulatory team can move straight to MOH registration instead of waiting on supplementary documentation.

ICH Zone IVb stability data, container-closure integrity results and preservative efficacy reports are available on request.

Product Overview

Field	Details
Product Name	Gentamicin Eye and Ear Drops
INN / Generic Name	Gentamicin Sulphate
Therapeutic Class	Aminoglycoside Antibiotic Topical Ophthalmic / Otic Anti-infective
Indications	Bacterial conjunctivitis, blepharitis, keratitis, corneal ulcer, otitis externa
API Quality	Manufactured using DMF-grade Gentamicin Sulphate
Pharmacopoeial Standard	BP / USP / IP
Available Strengths	0.3% w/v (3 mg/ml as Gentamicin base)
Dosage Forms	Eye Drops · Ear Drops · Combined Eye and Ear Drops · Eye Ointment
Pack Sizes	5 ml and 10 ml LDPE dropper bottles; institutional packs on request
Shelf Life	24 Months from date of manufacture
In-Use Shelf Life	Discard 28 days after first opening
Storage	Store below 25°C, protect from light. Do not freeze.
Manufacturing Facility	Dedicated Sterile Ophthalmic Block WHO-GMP Certified
Sterilisation Method	Aseptic filtration through 0.22 µm membrane
Dossier Available	Yes CTD / ACTD / eCTD format
Regulatory Documents	CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, Sterility Report
Markets Served	Africa, Southeast Asia, LATAM, Middle East, CIS

Product Variants, Dosage Forms & Strengths

Gentamicin Eye Drops 0.3% w/v (5 ml / 10 ml)

Our highest-volume ophthalmic presentation and the format most frequently tendered by public health programmes.

Supplied as a clear, sterile, isotonic aqueous solution of Gentamicin Sulphate equivalent to 3 mg/ml of gentamicin base, preserved with benzalkonium chloride and filled into a light-protective LDPE bottle with a controlled-drop nozzle and tamper-evident cap.

Indicated use profile: superficial bacterial infections of the eye and adnexa in adult and paediatric patients.

Key markets: Nigeria, Kenya, Ghana, Tanzania, Philippines, Vietnam, Iraq, Yemen.

Gentamicin Ear Drops 0.3% w/v (5 ml / 10 ml)

The otic presentation is formulated at the same 0.3% w/v strength and is widely procured across humid, high-burden regions where otitis externa is a routine outpatient presentation.

Retail-pack and dispensary-pack artwork can be run separately from the ophthalmic SKU so that distributors can hold distinct trade dress in the same market.

Preferred in tropical and coastal markets with high seasonal ear-infection demand.

Gentamicin Eye and Ear Drops 0.3% w/v Dual-Indication Presentation

A single sterile solution registered for both ophthalmic and otic administration.

This is the most cost-efficient SKU for buyers running consolidated procurement, because one registration, one artwork set and one batch stream cover two therapeutic segments.

Strong demand in institutional, NGO and government tender channels.

Pharmacopoeial Compliance

BP (British Pharmacopoeia) Gentamicin Eye Drops BP; preferred across Commonwealth, African and Middle East markets.

USP (United States Pharmacopeia) Gentamicin Sulfate Ophthalmic Solution USP; the reference standard for LATAM tenders. IP (Indian Pharmacopoeia) available on request.

Sterility is tested per USP <71> / Ph. Eur. 2.6.1, and antimicrobial preservative effectiveness per USP <51> / Ph. Eur. 5.1.3. Please specify the pharmacopoeial standard required by your MOH at the enquiry stage so the correct specification is locked before batch allocation.

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document) ICH-aligned, for regulated and semi-regulated markets.

ACTD (ASEAN Common Technical Dossier) for Philippines, Vietnam, Myanmar, Indonesia, Cambodia. eCTD for authorities that mandate electronic submission.

Module 3 quality documentation covers sterile manufacturing process validation, media fill data, sterilising-grade filtration validation and container-closure system qualification.

Stability data includes real-time and accelerated, generated under ICH Zone IVb (30°C / 75% RH) conditions for hot and humid markets.

Country-specific dossier customisation and query response support available.

Bioequivalence Position Ophthalmic and Otic Solutions

For sterile ophthalmic and otic solutions, most regulatory authorities accept a biowaiver in place of a human bioequivalence (BE) study, provided the generic product is qualitatively and quantitatively identical (Q1/Q2) to the reference listed product and demonstrates comparable physicochemical performance.

Our dossiers carry comparative characterisation data assay, pH, osmolality, viscosity, particulate matter, preservative content and sterility in place of clinical BE.

Where a specific authority requires additional supporting data, our regulatory team will advise on the applicable route before submission.

Drug Master File (DMF)

Drug Master File (DMF) reference for the Gentamicin Sulphate API is available for cross-referencing in your registration dossier.

API is sourced against a qualified vendor with full elemental impurity and residual solvent data shortens authority query cycles.

CDSCO / Indian DMF reference accepted by a large number of importing authorities.

Manufacturing Compliance

WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis. Site Master File (SMF) available for regulatory submissions.

Dedicated sterile ophthalmic block Grade A filling under Grade B background per ISO 14644, with HEPA-filtered unidirectional airflow, gowning qualification and routine environmental monitoring.

Aseptic process validated through periodic media fill runs; sterilising-grade 0.22 µm filtration validated for bacterial retention.

Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Philippines, DRAP (Pakistan) and INVIMA (Colombia).

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms batch quality against the agreed specification
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most importing countries
Free Sale Certificate (FSC)	Confirms the product is freely sold in the country of manufacture
Method of Analysis (MOA)	Analytical methodology mandatory dossier component
GMP Certificate	Confirms manufacturing site compliance
Stability Data	Real-time and accelerated ICH Zone IVb for tropical markets
Sterility Test Report	USP <71> / Ph. Eur. 2.6.1 product-critical for a sterile dosage form
Preservative Efficacy Test (PET)	USP <51> supports the 28-day in-use shelf life claim
Container Closure Integrity Test (CCIT)	Demonstrates sterility is maintained across the shelf life
Extractables & Leachables Data	For the LDPE bottle and closure system
Non-Animal Origin Declaration	No animal-derived excipients used
Batch Manufacturing Records (BMR)	Available on request, NDA basis

Clinical Indications & Therapeutic Information

Gentamicin is a broad-spectrum aminoglycoside antibiotic with activity against a wide range of Gram-negative organisms, including Pseudomonas aeruginosa, as well as staphylococcal species the pathogen profile that drives most topical ocular and otic prescribing in high-burden markets.

Gentamicin eye drops 0.3% are listed on the WHO Model List of Essential Medicines for blepharitis and conjunctivitis, which underpins consistent inclusion in national essential medicines lists and public procurement cycles

Common ophthalmic indications: bacterial conjunctivitis, blepharitis, keratitis and corneal ulcer

Common otic indication: otitis externa and secondary bacterial infection of the external auditory canal

Dosing frequency and duration are prescriber-guided and vary with infection severity, patient age and clinical presentation

Dedicated sterile block manufacturing eliminates cross-contamination risk a decisive evaluation point for ophthalmic buyers, since a sterility failure in an eye preparation is a patient-safety event, not a quality deviation

Demand across sub-Saharan Africa and Southeast Asia is sustained by high ocular infection burden, dense paediatric populations and ongoing trachoma-elimination programmes producing predictable, repeat import volumes

Target Export Markets

Africa

Active markets: Nigeria, Kenya, Tanzania, Ghana, Uganda, Ethiopia, Zambia, Cameroon, Côte d’Ivoire, Sudan.

Registration support: NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Ghana CoPP and FSC are the primary gatekeeping documents.

Labelling: English and French artwork available for Anglophone and Francophone Africa.

Southeast Asia

Active markets: Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh.

ACTD dossier format supplied as standard mandatory for ASEAN registrations.

Stability: ICH Zone IVb packages are non-negotiable in this climate zone and are already generated for this product.

Latin America (LATAM)

Active markets: Colombia, Peru, Ecuador, Bolivia, Guatemala, Honduras, Dominican Republic.

USP pharmacopoeial standard preferred; Spanish-language labelling and inserts available.

CTD format with local regulatory adaptation and legalisation/apostille support.

Middle East & CIS

Active markets: Iraq, Yemen, Jordan, Uzbekistan, Kazakhstan, Kyrgyzstan, Azerbaijan.

GMP Certificate and CoPP are the primary registration requirements across these authorities.

Arabic and Russian labelling available on request.

Export Packaging & Supply Chain

Primary Packaging Options

Dosage Form	Packaging Options
Eye Drops / Ear Drops	5 ml and 10 ml LDPE dropper bottle with controlled-drop nozzle and tamper-evident screw cap
Combined Eye and Ear Drops	5 ml / 10 ml LDPE bottle, mono-carton with dual-indication insert
Institutional / Tender Supply	Bulk shipper cartons with programme-specific overprinting

Labelling & Customisation

Private label manufacturing with your brand name, artwork and trade dress.

Multi-lingual labelling: English, French, Spanish, Portuguese, Arabic, Russian.

Country-specific compliance built into artwork: NAFDAC number field, local registration number, batch/expiry format, storage statement and the 28-day in-use discard instruction.

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement. No cold chain required; shipment must be protected from direct heat and light, and containers should not be stowed against a hot bulkhead.

Documented export experience across Africa, CIS, LATAM and Southeast Asia, including port-clearance documentation support.

Why Source Gentamicin Eye and Ear Drops From Us?

WHO-GMP Certified Sterile Manufacturing Dedicated ophthalmic block with Grade A/B aseptic filling, validated media fills and continuous environmental monitoring.

GMP certificate and Site Master File (SMF) shared on request.

Complete Dossier for 100+ Countries CTD, ACTD and eCTD dossiers pre-compiled, with regulatory query response support included.

Cuts weeks off your market authorisation timeline.

Sterility Assurance You Can Audit Sterility, preservative efficacy and container-closure integrity data supplied per batch.

For an ophthalmic product this is the single most scrutinised evaluation criterion.

WHO Essential Medicine Listing Gentamicin 0.3% eye drops appear on the WHO Model List of Essential Medicines, which keeps the molecule inside national EMLs and government tender cycles year after year.

Private Label & Custom Packaging MOQ-based private labelling with your brand name, multi-lingual artwork and country-specific regulatory text.

End-to-End Regulatory Support From CoA to CoPP to FSC, all export documentation is handled in-house by a dedicated regulatory team through to MOH registration.

Frequently Asked Questions

Ready to Source Gentamicin Eye and Ear Drops FDF?

Share your target market and volume requirement, and our export team will respond with the applicable pharmacopoeial specification, dossier format, pack options and pricing.

If you are still at the evaluation stage, request the dossier summary and a sample CoA first no commitment required.