Paediatric Paracetamol

Paediatric Paracetamol, also known as acetaminophen, is one of the most trusted and widely used analgesic and antipyretic medications for children across all age groups. Recognized globally for its efficacy in relieving mild to moderate pain and reducing fever, Paediatric Paracetamol remains a first-line treatment in both hospital and home settings.

Formulated specifically for pediatric use, this medication is designed to ensure accurate dosing, palatable flavor, and safety in infants and children. Its inclusion in the World Health Organization (WHO) Model List of Essential Medicines for Children further highlights its significance in global healthcare.

At BluepillExpress, we specialize in the high-quality, WHO-GMP-certified third-party manufacturing of Paediatric Paracetamol formulations, supporting pharmaceutical companies, healthcare organizations, NGOs, and distributors globally.

About BluepillExpress

BluepillExpress is a leading Indian pharmaceutical contract manufacturer, delivering safe, scalable, and affordable third-party manufacturing solutions. With a core emphasis on pediatric and general medicine, we are known for:

• WHO-GMP & ISO-certified facilities
• Fully compliant formulations with international pharmacopoeias (IP, BP, USP)
• Flexible MOQs and private label support
• End-to-end regulatory, packaging, and logistics assistance
• Global exports to Africa, Southeast Asia, Latin America, CIS, and the Middle East

We manufacture pediatric medications that prioritize efficacy, safety, and child compliance, making us a reliable partner in healthcare.

Pharmacological Overview

• Generic Name: Paracetamol (Acetaminophen)
• Therapeutic Class: Analgesic and Antipyretic
• Pharmacopoeial Standards: IP/BP/USP
• Mechanism of Action: Inhibition of prostaglandin synthesis in the CNS
• Route of Administration: Oral
• Formulations Offered: Syrups, Oral Suspensions, Drops, Dispersible Tablets

Mechanism of Action

Paracetamol works by inhibiting cyclooxygenase enzymes (COX-1 and COX-2) in the central nervous system, thereby reducing the synthesis of prostaglandins, which are responsible for causing pain and fever. Unlike NSAIDs, it does not exhibit significant anti-inflammatory activity, making it safer for infants and children with sensitive digestive systems.

Paracetamol’s high therapeutic index, rapid onset of action, and minimal gastrointestinal side effects make it a superior choice in pediatric care.

Therapeutic Indications

Paediatric Paracetamol is widely prescribed for the following conditions:

• Fever (Pyrexia) due to infections or post-immunization
• Mild to moderate pain such as:
  • Toothaches
  • Headaches
  • Muscular pain
  • Post-vaccination discomfort
• Common cold and flu-related symptoms
• Pain due to teething in infants
• As an adjunct to antibiotics or antivirals in febrile illnesses

It is often the first line of defense in febrile management protocols in public and private pediatric healthcare settings.

Formulations and Strengths Manufactured by BluepillExpress

BluepillExpress manufactures Paediatric Paracetamol in multiple formulations tailored to the needs of different age groups and market segments.

1. Paediatric Paracetamol Oral Suspension

• Strengths: 125 mg/5 ml, 250 mg/5 ml
• Flavor Options: Strawberry, Orange, Mango, Mixed Fruit
• Bottle Sizes: 30 ml, 60 ml, 100 ml, 150 ml
• Sugar-Free Versions: Available upon request
• Packing: HDPE bottles with measuring caps or droppers
• Shelf Life: 24–36 months
• Standard Compliance: IP, BP, USP

2. Paracetamol Infant Drops

• Strength: 100 mg/ml
• Packaging: 15 ml & 30 ml bottles with calibrated dropper
• Use: Suitable for infants under 1 year of age
• Flavor: Gentle fruit or vanilla flavors
• Preservative-Free Options: On demand

3. Paracetamol Dispersible Tablets (on request)

• Strength: 125 mg, 250 mg
• Flavor: Orange, Banana
• Use: Easily disperses in water; suitable for toddlers
• Packaging: Blister strips or unit dose foil packs

Each batch is designed to ensure dose accuracy, palatability, and high stability, especially in tropical climates.

Manufacturing Facility Capabilities

Our WHO-GMP and ISO 9001:2015 certified manufacturing facilities are equipped with state-of-the-art technology and compliant with international safety, hygiene, and documentation standards.

Facility Highlights:

• Automated syrup manufacturing and filling lines
• Cleanrooms with controlled temperature and humidity
• UV filtration and deionized water systems
• Dedicated pediatric production zones
• Advanced analytical laboratories
• Sustainable packaging and waste management systems

We operate with a capacity to manufacture millions of syrup bottles and oral drops annually, suitable for both private and institutional demands.

Quality Control and Assurance

At BluepillExpress, we follow a robust Quality Assurance (QA) and Quality Control (QC) process at every stage—from raw material procurement to finished product dispatch.

Our QC Protocols Include:

• API identification and purity (HPLC/UV analysis)
• Suspension homogeneity and sedimentation testing
• Microbial limit and preservative efficacy testing
• Viscosity, pH, and flavor stability checks
• Real-time and accelerated stability studies
• Child-friendly bottle design testing (leakage, dosing accuracy)

Every batch of Paediatric Paracetamol is issued with:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Raw Material Specifications
• Stability Data Sheets

Packaging and Labeling Services

We offer customized packaging and private label branding options to meet the exact needs of your markets and regulatory authorities.

Available Packaging Features:

• HDPE bottles with tamper-evident caps and childproof closures
• Color-coded labels for different strengths
• Dosing instructions and measuring cups/droppers included
• Bilingual or multilingual printed cartons and inserts
• Serialization, QR codes, and barcodes for traceability
• Temperature-resistant, export-ready packaging

Our packaging is designed to ensure safety, convenience, and clear communication for caregivers and pharmacists.

Regulatory Documentation and Support

We provide full documentation support for product registration in your local health authority, ministry, or drug regulatory agencyDocuments Provided Include:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (COA)
• Free Sale Certificate
• Certificate of Origin
• Stability Data (Real-Time and Accelerated)
• Product Specification Sheet and MSDS
• CTD/ACTD Dossier (on request)
• Artwork and packaging mockups for approval

We have successfully supported product registrations across Africa, Southeast Asia, Latin America, and CIS countries.

Private Label and Manufacturing Process Workflow

At BluepillExpress, we simplify the manufacturing process with a streamlined workflow and dedicated project management for each client.

Our Process:

1. Product Requirement Analysis: Choose dosage form, strength, packaging
2. Quotation and Contract: Transparent pricing, timelines, and MOQs
3. Artwork and Branding Finalization: Use your artwork or let our designers assist
4. Sample and Lab Batch: Formulated for review or registration
5. Manufacturing and QC: Large-scale production with rigorous testing
6. Packaging and Labeling: Custom printing and multilingual support
7. Shipping and Documentation: Global logistics with full export compliance

We accept low minimum order quantities (MOQs) to accommodate startups and NGOs while also scaling up for large procurement programs.

Target Markets and Export Experience

BluepillExpress exports Paediatric Paracetamol to over 50 countries, including:

• Africa: Nigeria, Kenya, Ghana, Ethiopia, Tanzania
• Asia: Nepal, Myanmar, Cambodia, Sri Lanka
• Middle East: Iraq, Yemen, UAE, Jordan
• CIS: Uzbekistan, Kazakhstan, Armenia
• Latin America and the Caribbean: Haiti, Bolivia, Dominican Republic

We serve:

• Private pharmaceutical brands
• Government health departments and immunization programs
• NGO medical missions and child health campaigns
• Pediatric clinics, retail chains, and hospitals

Sustainability and Ethical Standards

We believe in sustainable, ethical, and socially responsible pharmaceutical production, including:

• Eco-friendly, zero-discharge water management systems
• Solar and energy-efficient facility management
• Recyclable and biodegradable packaging
• No child labor or unethical sourcing practices
• Fair hiring and inclusive workplace practices

We align our initiatives with UN Sustainable Development Goals (SDGs)—particularly SDG 3: Ensure healthy lives and promote well-being for all at all ages.

Why Choose BluepillExpress for Paediatric Paracetamol Manufacturing?

• WHO-GMP and ISO-certified production for global compliance
• Multiple pediatric formulations (syrup, drops, dispersible tablets)
• Custom packaging and private labeling support
• Regulatory documentation and registration assistance
• Flexible batch sizes and competitive pricing
• Fast lead times and global export capabilities
• Ethical manufacturing practices and sustainable operations

Whether you’re a growing pharmaceutical brand, a public health organization, or a global supplier, BluepillExpress delivers Paediatric Paracetamol with excellence, integrity, and dependability.

Conclusion

Paediatric Paracetamol is a cornerstone in pediatric medicine, relied upon by healthcare providers, caregivers, and public health systems for its effectiveness, safety, and accessibility. With a strong emphasis on child-friendly design and regulatory excellence, its manufacturing requires specialized expertise and stringent controls.

At BluepillExpress, we combine advanced technology, global certifications, and personalized service to offer third-party manufacturing of Paediatric Paracetamol that meets the highest standards. From formulation development to international export, we provide a complete turnkey solution that empowers your brand in every market.