The pharmaceutical industry in India has seen an exponential rise in the third-party manufacturing model, also known as contract manufacturing. This model allows marketing companies to outsource drug production to GMP-certified manufacturers while focusing on sales, marketing, and branding. One such high-demand product for third party manufacturing of Paracetamol Tablets IP 650mg is phenomenal.
Paracetamol, also known as acetaminophen, belongs to the analgesic and antipyretic therapeutic category. With a global paracetamol market valued at USD 1.3 billion in 2023 and expected to grow steadily, this OTC drug remains a staple in every pharmacy. It is widely used for fever, headaches, cold, flu, and mild to moderate pain relief, making it a popular product for wholesalers, retailers, and pharma startups.
Also Read: Third Party Manufacturing of Rabeprazole and Domperidone SR Capsules
Product Overview
- Composition: Paracetamol IP 650mg
- Dosage Form: Tablets
- Strength: 650mg
- Uses:
- Reduces fever
- Relieves headaches and body aches
- Common cold and viral fever relief
- Regulatory Classification:
- Schedule H (India) – Must be sold under the supervision of a registered medical practitioner.
- OTC in many countries, but labeling must comply with local drug authorities.
Third-Party Manufacturing Process for Paracetamol Tablets IP 650mg
Step-by-Step Process:
- Product Inquiry & Quotation
- Select product, quantity, and packing style
- Receive a price quotation from the manufacturer
- Finalization & Documentation
- Submit documents (see below)
- Finalize artwork and packaging
- Production Initiation
- Procurement of raw materials
- Tablet compression, coating, and packaging
- Quality Testing & Approval
- In-process and final batch testing
- QC/QA approvals before dispatch
- Dispatch & Delivery
- Final packing
- Logistics arrangement and shipment
Required Documents:
- Drug License (Form 20B/21B)
- GST Number
- Company PAN Card
- LOI (Letter of Intent)
- Brand Name Confirmation
- Packaging Material Details
Paracetamol Tablets IP 650mg Role Distribution:
- Manufacturer: Handles production, testing, and compliance
- Marketing Company: Responsible for branding, sales, and market distribution
Quality & Compliance Considerations
When dealing with Paracetamol Tablets IP 650mg, quality assurance is crucial.
- cGMP and WHO-GMP Compliance: Ensures regulatory acceptance
- ISO Certifications: Adds brand credibility
- Testing Parameters: Assay, dissolution, disintegration, microbial load
- Stability Testing: Especially for tropical zones
- Packaging Requirements: Strip/blister/aluminum foil packaging with clear label claims, batch details, and expiry
Cost and Investment Breakdown
MOQ (Minimum Order Quantity):
- Generally, 500 boxes (each box contains 10×10 tablets)
Typical Costing Structure of Paracetamol Tablets IP 650mg:
| Cost Component | Approximate Value (INR) |
|---|---|
| Manufacturing Cost | ₹0.18 – ₹0.25/tablet |
| Packing Material | ₹0.10 – ₹0.15/tablet |
| Freight & Transportation | ₹1,500 – ₹3,000 per consignment |
| Product Testing & QC | ₹3,000 – ₹5,000/batch |
| GST | 12% |
Tips for Cost Optimization:
- Order in larger quantities
- Finalize artwork with standard sizes
- Use cost-effective but compliant packaging
- Avoid frequent design changes
Choosing the Right Manufacturer
How to Shortlist:
- WHO-GMP certified plant
- Years of experience in tablet manufacturing
- References from existing clients
- Facility audit (if feasible)
Important Questions to Ask:
- What is the lead time?
- Are all raw materials sourced in-house or outsourced?
- Can you provide batch-wise COA and QC reports?
- Do you support packaging design?
Red Flags to Avoid:
- Lack of transparency
- No certification display
- Delayed response
- Poor communication
Marketing and Branding Strategy
- Packaging Differentiation: Choose attractive colors, metallic foil effects, or minimalist branding for professional appeal
- Promotional Materials:
- Visual Aids
- MR Bags
- Product Cards
- Physician samples
- Digital Promotion: Leverage Google Ads, SEO, and YouTube for brand awareness
Regulatory and Legal Compliance
- Label Claims Must Include:
- Composition
- Schedule Warning (Rx only)
- Batch no., Mfg/Exp date, MRP
- Storage instructions
- Pharmacovigilance:
- Monitor adverse effects
- Keep records of complaints and follow-up
- Product Liability:
- Ensure professional indemnity coverage
- Avoid false claims in packaging or promotion
FAQs:
1. What is the third-party manufacturing of Paracetamol Tablets IP 650mg?
It’s a process where a pharma company outsources the production of paracetamol tablets to a certified manufacturer under their brand name.
2. What documents are required to start third-party manufacturing?
Drug license, GST, LOI, and PAN card.
3. What is the current price of Paracetamol Tablets IP 650mg for contract manufacturing?
Current price of Paracetamol Tablets IP 650mg is Approx. ₹0.40 to ₹0.45 per tablet, depending on quantity and packaging.
4. How long does it take to manufacture 500 boxes of paracetamol tablets?
Generally,30 to 35 working days from order confirmation and artwork finalization.
5. Is Paracetamol Tablet 500mg an OTC or prescription drug?
It’s Schedule H in India (Rx) but available OTC in many countries.
6. What are the common pack sizes?
10×10 tablets per box is most common. Custom packs like 1×15 or 2×10 are also available.
7. Can I export third party manufactured paracetamol tablets?
Yes, you can export medicines with proper documentation required by the importing country.
