Paracetamol

BluepillExpress is a leading pharmaceutical company based in India, renowned for its commitment to excellence, regulatory compliance, and international quality standards. As a globally trusted name in third-party manufacturing, BluepillExpress specializes in producing a broad range of pharmaceutical products, including analgesics and antipyretics such as Paracetamol. This document provides an in-depth overview of our third-party manufacturing services for Paracetamol, highlighting the benefits, technical specifications, regulatory standards, and manufacturing capabilities that make BluepillExpress the preferred partner for global clients.

About Paracetamol

Paracetamol, also known as acetaminophen, is one of the most widely used over-the-counter (OTC) drugs worldwide for the relief of fever and mild to moderate pain. It is a non-opioid analgesic and antipyretic, often used for conditions such as headaches, muscle aches, backaches, arthritis, toothaches, colds, and fevers.

Key Properties of Paracetamol:

• Therapeutic Class: Analgesic and Antipyretic
• CAS Number: 103-90-2
• Molecular Formula: C8H9NO2
• Mechanism of Action: Inhibits prostaglandin synthesis in the central nervous system, providing pain relief and fever reduction without significant anti-inflammatory effects.

BluepillExpress as Your Trusted Manufacturing Partner

BluepillExpress offers full-service third-party manufacturing for Paracetamol across various dosage forms and strengths. With world-class infrastructure, a dedicated team of pharmaceutical scientists, and adherence to stringent international regulations, we ensure each product manufactured meets the highest standards of quality and safety.

Why Choose BluepillExpress?

• Global Reach: Exporting to over 140 countries across Asia, Africa, Latin America, CIS, and Europe
• Certifications: WHO-GMP, ISO 9001:2015, FSSAI, DCGI, and other international regulatory compliances
• Scalability: Flexible manufacturing capacities tailored to both small-scale and bulk requirements
• Expertise: Decades of experience in pharmaceutical formulation, packaging, labeling, and export logistics
• Regulatory Support: Full documentation assistance including CTD/ACTD dossier preparation, stability data, COA, MOA, COPP, FSC, and more

Paracetamol Formulations Offered

BluepillExpress provides extensive flexibility in manufacturing Paracetamol-based products in a variety of dosage forms, ensuring suitability for all age groups and markets.

Available Dosage Forms:

1. Tablets:
   • Paracetamol 500 mg
   • Paracetamol 650 mg (popular for fever management during viral infections)
   • Extended-release formulations as per client requirement
2. Syrups/Suspensions:
   • Paracetamol 125 mg/5 ml
   • Paracetamol 250 mg/5 ml
   • Sugar-free and flavor-enhanced variants available
3. Pediatric Drops:
   • Paracetamol 100 mg/ml or customized strengths
4. Suppositories:
   • Paracetamol 80 mg / 125 mg / 250 mg for pediatric use
5. Effervescent Tablets:
   • Fast-dissolving variants for adult and elderly populations
6. Injectables (on demand):
   • Paracetamol IV infusion 1 g/100 ml – available in hospital-grade packaging

Customized Manufacturing

Our team works closely with clients to manufacture customized formulations, packaging styles, and branding based on their regional regulatory needs and consumer preferences. This includes:

• Flavor and color modifications
• Packaging in bottles, blisters, strips, and cartons
• Private label branding

Manufacturing Infrastructure

At BluepillExpress, we have invested in cutting-edge manufacturing infrastructure designed to meet the rigorous standards of global pharmaceutical markets.

Facility Highlights:

• Manufacturing Units: Equipped with HVAC-controlled clean rooms and automated production lines
• Technology: High-speed tablet compression machines, liquid filling lines, coating pans, and blister packaging units
• Quality Control Lab: Fully equipped in-house lab for raw material testing, in-process checks, and finished product validation
• Storage: Controlled warehouses for raw materials and finished goods, ensuring stability and shelf life

Quality Assurance and Regulatory Compliance

Our commitment to quality is embedded in every step of the manufacturing process. Each batch of Paracetamol manufactured under BluepillExpress undergoes strict quality checks to ensure purity, potency, and safety.

Quality Systems Include:

• Raw Material Testing: Only pharmacopeia-grade APIs and excipients used (IP, BP, USP grade)
• In-Process Controls (IPC): Continuous monitoring during each stage of manufacturing
• Finished Product Testing: Assay, dissolution, microbial tests, uniformity of dosage units, etc.
• Stability Studies: Conducted as per ICH guidelines for various climatic zones
• Documentation: Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and Certificate of Analysis (COA) provided

Our facilities are audited regularly to ensure ongoing compliance with Good Manufacturing Practices (GMP). We also support partners with:

• Regulatory filings
• Product registrations
• CTD and ACTD dossier submissions
• Free Sale Certificates (FSC)
• Stability data and validation protocols

Packaging and Labeling

We understand that packaging plays a critical role in brand differentiation and consumer trust. BluepillExpress offers a range of packaging solutions for Paracetamol that are tamper-evident, child-resistant, and compliant with international labeling norms.

Packaging Options:

• Blister packs (PVC, PVDC, Alu-Alu)
• Strip packs
• Bottles (HDPE, amber glass, PET)
• Cartons with inserts or multilanguage labeling
• Bulk packaging for institutional supply

Private label and OEM services are available for clients wishing to market Paracetamol under their brand name.

Export Markets and Logistics

BluepillExpress is highly experienced in managing the global supply chain for pharmaceutical exports. We have a robust export team that ensures seamless logistics, customs clearance, and documentation support.

Export Highlights:

• Air and sea freight options with temperature-controlled logistics
• Coordination with international regulatory bodies
• Assistance with legal and compliance requirements for destination countries
• Timely order fulfillment with real-time tracking

We are actively exporting Paracetamol to countries in Africa, Southeast Asia, Latin America, the Middle East, and CIS nations. Our familiarity with each market’s regulatory framework helps clients avoid delays and streamline market entry.

Benefits of Partnering with BluepillExpress

When you choose BluepillExpress for Paracetamol manufacturing, you gain more than just a production partner—you gain a strategic ally focused on your brand’s success.

Key Advantages:

• End-to-end support from formulation to shipment
• Transparent pricing and cost-effective solutions
• Customizable production to meet brand and dosage needs
• Access to certified raw materials and robust supply chain
• Fast turnaround times and consistent batch quality
• Dedicated account managers for personalized service

Whether you are a startup launching your first OTC product or an established pharmaceutical distributor seeking a reliable bulk manufacturer, BluepillExpress can tailor solutions that align with your business objectives.

Sustainability and Corporate Responsibility

BluepillExpress is committed to environmentally responsible manufacturing. We follow green chemistry practices, minimize waste, and adhere to environmental norms set by national and international bodies.

• Effluent Treatment Plants (ETP)
• Waste disposal as per biomedical waste guidelines
• Energy-efficient machinery and operations
• CSR initiatives in public health and education

Our commitment to sustainability is part of our larger vision to deliver health solutions that care for both people and the planet.