Xylometazoline

Xylometazoline is a widely used topical nasal decongestant that provides fast and effective relief from nasal congestion caused by common colds, allergic rhinitis, sinusitis, and upper respiratory tract infections. Its rapid onset of action and prolonged duration make it a preferred first-line therapy in ENT (Ear, Nose, Throat) treatment protocols across the globe.

At BluepillExpress, we specialize in the third-party manufacturing of Xylometazoline-based formulations. Backed by WHO-GMP certified manufacturing facilities, stringent quality assurance, and end-to-end regulatory support, we deliver high-quality Xylometazoline nasal drops and sprays customized to your brand requirements. Whether you’re a generic distributor, a private label brand, or a public health tender participant, we help you scale efficiently and globally with compliant, effective, and market-ready solutions.

What is Xylometazoline?

Xylometazoline is a sympathomimetic agent that acts on alpha-adrenergic receptors in the nasal mucosa, causing vasoconstriction, which reduces swelling and congestion of nasal passages. It provides rapid relief within minutes and lasts for up to 10 hours, making it ideal for symptomatic treatment of nasal obstruction.

Therapeutic Class: Nasal Decongestant
Mechanism of Action: Alpha-adrenergic agonist causing vasoconstriction in nasal mucosa
Route of Administration: Intranasal (drops/spray)

Therapeutic Indications

Xylometazoline is used to relieve short-term nasal congestion in various ENT and upper respiratory tract conditions.

Primary Indications:

• Acute and chronic rhinitis
• Common cold and flu-related congestion
• Allergic rhinitis (seasonal or perennial)
• Sinusitis and nasal polyps
• Post-nasal drip management
• Otitis media (as adjunct therapy)
• Pre- and post-operative nasal care
• Before ENT diagnostic procedures (to reduce mucosal swelling)

Its efficacy, safety profile, and local action make it an essential component of ENT treatment kits and over-the-counter cold and allergy products.

Why Choose BluepillExpress?

At BluepillExpress, we bring formulation science and regulatory expertise together to create compliant and effective nasal decongestant formulations like Xylometazoline. With advanced production infrastructure, we meet global quality benchmarks and provide scalable solutions for brand owners and institutional buyers.

Key Benefits:

• WHO-GMP & ISO 9001:2015 certified facilities
• Specialized nasal spray filling and packaging lines
• Precision dosing systems and sterilized bottling units
• IP/BP/USP/EP compliant formulations
• Customizable volumes and concentrations
• Full regulatory and export documentation
• Private label, OEM, and white label options
• Experienced ENT and respiratory formulation R&D team

We deliver quality, consistency, and speed, ensuring your product reaches the market on time and fully compliant.

Available Dosage Forms and Concentrations

We manufacture Xylometazoline formulations in both adult and pediatric strengths, in nasal drop and nasal spray forms.

Common Formulations:

• Xylometazoline Nasal Drops 0.05% w/v (Pediatric use)
• Xylometazoline Nasal Drops 0.1% w/v (Adult use)
• Xylometazoline Nasal Spray 0.05% w/v
• Xylometazoline Nasal Spray 0.1% w/v

Packaging Sizes:

• 10 mL and 15 mL dropper bottles
• 10 mL and 20 mL metered-dose nasal spray bottles
• Amber or white HDPE bottles with tamper-evident seals
• Customized packaging for OTC or prescription products

We also provide sterile single-use ampoules or vials for hospital-grade supply upon request.

Product Composition

We use high-purity APIs and pharmaceutical-grade excipients to formulate safe, stable, and effective Xylometazoline products.

Example: Xylometazoline Nasal Spray 0.1%

• Active Ingredient: Xylometazoline Hydrochloride IP/BP/USP 0.1% w/v
• Preservatives: Benzalkonium Chloride (optional or preservative-free on request)
• Buffering Agents: Sodium phosphate buffer to maintain pH
• Vehicle: Purified water

We offer preservative-free formulations and non-irritant buffered solutions to meet sensitive consumer needs and country-specific regulations.

Manufacturing Process

Our production facilities include dedicated cleanrooms and sterile areas for nasal preparation manufacturing, including aseptic filling, nitrogen flushing, and automated sealing lines.

Process Flow:

1. Raw Material Inspection and QC Approval
2. Solution Preparation in Sterile Stainless Steel Vessels
3. Filtration (0.2 µm) for microbial safety
4. Aseptic Filling in Controlled Environment
5. Labeling and Tamper-Proof Capping
6. Visual Inspection and Batch Coding
7. Secondary Packaging with Leaflet/Carton

Our validated manufacturing processes ensure dosage uniformity, pH consistency, and product sterility in every batch.

Quality Control and Testing

Each batch of Xylometazoline is subjected to comprehensive testing in our in-house QC laboratories equipped with HPLC, UV-VIS, and microbial testing systems.

QC Parameters:

• Assay (API strength verification)
• pH and osmolarity testing
• Sterility testing (per pharmacopeial standards)
• Preservative efficacy testing (PET)
• Microbial limit testing
• Viscosity, color, odor, and appearance checks
• Packaging integrity and drop consistency

A complete Certificate of Analysis (COA) is issued with every consignment for traceability and compliance.

Packaging and Customization

BluepillExpress offers flexible and customized packaging options for clients in both regulated and semi-regulated markets.

Packaging Features:

• LDPE/HDPE bottles with calibrated droppers
• Metered-dose pump sprays with child-resistant caps
• Sterile blister-packaged ampoules (optional)
• Mono cartons with patient information leaflet
• Multilingual labels and international barcoding
• Track and trace options (serialization/QR code)

We help clients build their own private label brands, tailored to customer needs and regional compliance norms.

Regulatory and Documentation Support

We provide full regulatory documentation support to meet global compliance requirements, enabling a smooth market entry and long-term product lifecycle management.

Provided Documentation:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Product Dossier (CTD or ACTD)
• Certificate of Analysis (COA)
• Master Formula Record (MFR)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Safety Data Sheet (SDS)
• Label Claims and PIL (Patient Information Leaflet)

We have experience with registrations in Africa, Southeast Asia, CIS, LATAM, and Middle Eastern countries.

Export and Supply Chain Capabilities

BluepillExpress is a trusted partner for global supply and export of ENT medications like Xylometazoline. We ensure efficient, compliant, and timely shipments.

Export Destinations:

• Africa: Kenya, Nigeria, Tanzania, Uganda, Ethiopia
• Asia: Bangladesh, Vietnam, Sri Lanka, Nepal, Philippines
• Middle East: UAE, Iraq, Yemen, Jordan
• CIS Region: Kazakhstan, Uzbekistan, Kyrgyzstan
• Latin America: Bolivia, Peru, Dominican Republic
• Island Nations: Maldives, Fiji, Papua New Guinea

We handle full logistics—from documentation and customs clearance to cold chain shipping where required.

Who Should Partner with BluepillExpress?

Our Xylometazoline manufacturing services are suitable for:

• Generic pharmaceutical companies
• ENT product-focused brands
• Hospital and institutional supply chains
• OTC product marketers and online pharmacies
• Government tenders and NGO-based distributors
• Private label brand owners
• Telemedicine and e-pharmacy businesses

Why BluepillExpress?

• WHO-GMP certified facilities with nasal formulation expertise
• Customizable strengths, volumes, and packaging
• Full regulatory and technical documentation support
• Flexible batch sizes (MOQ-friendly)
• Competitive pricing for domestic and international clients
• Fast turnaround and dependable quality
• Global reach and reliable supply chain