Introduction

We are a WHO-GMP certified pharmaceutical exporter supplying Betamethasone and Neomycin Eye and Ear Drops finished dosage formulations to importers and distributors across Africa, Southeast Asia, and the Middle East & CIS.

This combination formulation of Betamethasone (a synthetic corticosteroid) with Neomycin (an aminoglycoside antibiotic)  is manufactured as a sterile ophthalmic and otic drop, optimized for accurate dose delivery, ocular/aural tolerability, and patient compliance across topical anti-inflammatory and anti-infective therapy.

Every shipment is backed by a complete regulatory dossier, enabling fast-track market authorization and MOH registration in your country.

Product Overview Table

Field	Details
Product Name	Betamethasone and Neomycin Eye and Ear Drops
INN / Generic Name	Betamethasone Sodium Phosphate + Neomycin Sulphate
Therapeutic Class	Corticosteroid + Aminoglycoside Antibiotic Combination (Ophthalmic/Otic)
Indications	Steroid-responsive inflammatory conditions of the eye and ear with associated or suspected bacterial infection (e.g. conjunctivitis, blepharitis, otitis externa)
API Quality	Manufactured using DMF-grade Betamethasone Sodium Phosphate and Neomycin Sulphate
Pharmacopoeial Standard	BP / USP / IP (confirm applicable standard per buyer requirement)
Available Strengths	Betamethasone 0.1% w/v + Neomycin 0.5% w/v
Dosage Form	Sterile Eye and Ear Drops (multi-dose dropper bottle)
Shelf Life	24 – 36 Months (unopened); in-use period per label after first opening
Storage	Store below 25°C, protect from light; discard as per in-use shelf life after opening
Manufacturing Facility	WHO-GMP Certified Facility – dedicated sterile ophthalmic/otic manufacturing line
Dossier Available	Yes, CTD / ACTD / eCTD format
Regulatory Documents	CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data
Markets Served	Africa, Southeast Asia, Latin America, Middle East & CIS

Product Variant, Dosage Form & Strength

Betamethasone and Neomycin Eye and Ear Drops (0.1% + 0.5% w/v)

Sterile multi-dose eye and ear drop for combined anti-inflammatory and anti-infective topical therapy

Key markets: Africa, Middle East, CIS, and Southeast Asian retail pharmacy and hospital channels

Keyword target: Betamethasone Neomycin eye drops exporter, Betamethasone Neomycin ear drops supplier

Pharmacopoeial Compliance

BP (British Pharmacopoeia) –  Commonwealth, African, Middle East markets

USP (United States Pharmacopeia) – LATAM and global reference

IP (Indian Pharmacopoeia) – available on request

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document) – ICH-aligned and most regulated markets

ACTD (ASEAN Common Technical Dossier) – Philippines, Vietnam, Myanmar, Indonesia, Cambodia

eCTD (Electronic CTD) – for markets requiring electronic submissions

Country-specific dossier customization available on request

Dossier includes: Quality Module (Module 3), Safety & Efficacy summaries as applicable.

Sterility & Preservative Efficacy

As a sterile topical ophthalmic/otic formulation, Betamethasone and Neomycin Eye and Ear Drops is manufactured and tested to sterility and preservative-efficacy specifications rather than oral bioequivalence.

Preservative efficacy and sterility test data available on request to support regulated-market dossier submissions

Drug Master File (DMF)

API Drug Master File (DMF) references available for both Betamethasone Sodium Phosphate and Neomycin Sulphate, for cross-referencing in the buyer’s regulatory dossier

Helps reduce registration timelines in the importing country

CDSCO / Indian DMF available – reference acceptable for many markets

Manufacturing Compliance

WHO-GMP certified manufacturing facility

Site Master File (SMF) available for regulatory submissions

Facility audit-ready; inspection reports available on NDA basis

Dedicated sterile ophthalmic/otic manufacturing suite with aseptic filling – ensures sterility and particulate-free drop formulation.

Compliant with: NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania).

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms product quality against specifications
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most countries
Free Sale Certificate (FSC)	Confirms product is freely sold in country of manufacture
Method of Analysis (MOA)	Lab testing methodology — required for dossier
GMP Certificate	Confirms manufacturing facility compliance
Stability Data	Real-time and accelerated — ICH Zone IVb for tropical markets
Batch Manufacturing Records (BMR)	Available on request (NDA basis)
Excipient Declarations	For all inactive ingredients used

Clinical Indications & Therapeutic Information

Betamethasone and Neomycin Eye and Ear Drops combines a corticosteroid with an aminoglycoside antibiotic for topical use in the eye and ear.

Key indications: steroid-responsive inflammatory conditions of the eye (e.g. allergic/inflammatory conjunctivitis, blepharitis) and ear (e.g. otitis externa) with associated or suspected bacterial infection

Dosage and duration vary based on the site and severity of the condition – prescriber-guided

Manufactured in a dedicated sterile ophthalmic/otic facility, ensuring a particulate-free, preservative-validated formulation – a critical safety point for regulated-market buyers

High market demand in regions with significant burden of ocular and otic infections, including Africa, the Middle East, and Southeast Asia, driving consistent retail and institutional procurement volumes

Target Export Markets

Africa

Nigeria, Kenya, Tanzania, Ghana, Uganda, Ethiopia, Zambia, Cameroon, Côte d’Ivoire.

Focus: FSC, NAFDAC registration support (Nigeria), PPB (Kenya), TFDA (Tanzania), PCPB (Ghana)

Language: English, French labeling available for Francophone Africa

Southeast Asia

Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh

Focus: ACTD dossier format  mandatory for ASEAN market registrations

Stability: Tropical formulations (ICH Zone IVb) – critical for this climate region

Latin America (LATAM)

Colombia, Peru, Ecuador, Bolivia, Guatemala, Honduras

Focus: Spanish labeling, USP pharmacopoeial standard preferred

Dossier: CTD format with local regulatory adaptation support

Middle East & CIS

Iraq, Yemen, Uzbekistan, Kazakhstan, Kyrgyzstan

Focus: GMP Certificate and CoPP are primary registration requirements

Language: Arabic and Russian labeling available on request

Export Packaging & Supply Chain

Primary Packaging Options

Dosage Form	Packaging Options
Eye and Ear Drops	5 mL / 10 mL LDPE dropper bottle with tamper-evident cap, individually cartoned
Bulk / Institutional Supply	Bulk pack for hospital/institutional procurement available on request

Labeling & Customization

Private label manufacturing available with custom brand name and artwork

Multi-lingual labeling: English, French, Spanish, Portuguese, Arabic, Russian

Country-specific labeling compliance: NAFDAC text, KEBS, local registration number fields

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW – as per buyer requirement

Shipment lead time: 45 to 60 Days from order confirmation

Experienced in shipping to Africa, CIS, LATAM, and Southeast Asia

Why Source Betamethasone and Neomycin Eye and Ear Drops From Us?

WHO-GMP Certified Manufacturing: All formulations are manufactured under WHO-GMP standards in a dedicated sterile ophthalmic/otic facility. Audit-ready; GMP certificates and SMF available on request.

Complete Dossier for 100+ Countries  CTD, ACTD, and eCTD dossiers pre-prepared. Reduces your market authorization timeline. Country-specific customization on request.

Validated Sterility & Preservative Efficacy  Full sterility assurance and preservative-efficacy data available to support your dossier submission.

Private Label & Custom Packaging  MOQ-based private labeling with your brand name, artwork, multilingual labeling, and country-specific regulatory compliance.

Competitive Ex-Works Pricing  Direct manufacturer pricing with no middlemen. Volume-based pricing tiers available for distributors and government tenders.

End-to-End Regulatory Support: From CoA to CoPP to FSC, all export documentation handled. Dedicated regulatory team for MOH registration guidance.

Frequently Asked Questions (FAQ)