Nimesulide and Paracetamol Tablets belong to the NSAID (Non-Steroidal Anti-Inflammatory Drug) category, widely prescribed for fever, pain, and inflammation. The combination of Nimesulide 100 mg and Paracetamol 325 mg offers faster and broader relief in conditions like cold, flu, dental pain, arthritis, and postoperative pain. Both active ingredients are well-researched and commonly prescribed by healthcare professionals.
With rising cases of seasonal flu and joint pain in India, Paracetamol-based formulations are experiencing a surge in demand. The Indian analgesic market is expected to reach INR 4,500+ crore by 2026, making it a lucrative segment. Opting for third-party manufacturing of Nimesulide and Paracetamol Tablets instead of buying PCD brands provides control over branding, pricing, and market exclusivity, key to scaling your pharma business sustainably.
Also read this: Aceclofenac and Paracetamol Tablets
Product Overview: Nimesulide and Paracetamol Tablets
- Composition: Nimesulide 100 mg + Paracetamol 325 mg
- Dosage Form: Tablets
- Strengths: Standard dosage of Nimesulide 100 mg + Paracetamol 325 mg
Uses & Benefits of Nimesulide and Paracetamol Tablets
- Fever and mild-to-moderate pain relief
- Dental pain, muscle sprains, osteoarthritis, and throat infections pain.
- Dual-action: Nimesulide targets inflammation while Paracetamol reduces fever
Regulatory Classification:
- Schedule H drug in India
- Rx (prescription-only) medicine
- Requires warning label: “To be sold by retail on the prescription of a Registered Medical Practitioner only”
Third-Party Manufacturing Process for Nimesulide and Paracetamol Tablets
Here is a simplified, step-by-step guide:
1. Initial Inquiry & Quotation
- Submit product inquiry to the shortlisted manufacturers
- Share preferred composition, quantity, and branding needs
2. Document Submission
- Drug License (Retail/Wholesale)
- GST Registration
- Company Profile with PAN & Aadhar
- LOI (Letter of Intent)
3. Quotation Finalization
- Discuss formulation price (Ex-factory or inclusive of packaging & freight)
- Confirm MOQ: Minimum 500 boxes
4. Artwork & Packaging Approval
- Provide brand name, logo, and design elements
- Finalize foil, box, and label layout
5. Manufacturing & Quality Testing
- Production under WHO-GMP & ISO-certified conditions
- Batch testing for assay, dissolution, disintegration, and uniformity
6. Dispatch & Delivery
- Products are shipped with COA (Certificate of Analysis), invoice, and test reports
Quality & Compliance Considerations
- Compliance Standards: WHO-GMP, ISO 9001:2015
- Stability Testing: As per ICH guidelines
- Testing Parameters: Assay, friability, hardness, uniformity of content
- Packaging Regulations:
- Blister/Alu-Alu preferred
- Label must include: Schedule H warning, Mfg. license no., expiry, batch no., etc.
- Proper mention of “Prescription Only” as per Drugs and Cosmetics Act, 1940
Cost and Investment Breakdown
| Component | Approx. Cost (Per Box) |
|---|---|
| Manufacturing | ₹3.5 – ₹4 |
| Packing Material | ₹2 – ₹4 |
| Quality Testing | ₹0.50 – ₹1 |
| Freight & Logistics | ₹1 – ₹2 |
| GST (as applicable) | 12% on total invoice |
- MOQ: 500 boxes (10×10 tablets per box)
- Cost Optimization Tips:
- Use standardized packaging
- Order in bulk to reduce freight and testing cost per unit
- Opt for manufacturing hubs in Baddi, Una, or Kala Amb for better pricing
Choosing the Right Manufacturer
How to Shortlist:
- WHO-GMP, ISO Certification
- At least 5 years of contract manufacturing experience
- Capability to handle Nimesulide and Paracetamol formulations specifically
Questions to Ask:
- Do you provide product samples for QC checks?
- What’s the lead time for the first order?
- Do you help with artwork and regulatory documentation?
Red Flags to Avoid:
- Lack of documentation transparency
- No testing reports or COAs
- Unregistered or unlicensed facilities
Marketing and Branding Strategy
- Packaging Design Tips:
- Use unique colors and bold fonts
- Clearly highlight the composition and benefits
- Add doctor-friendly branding
- Promotional Material Ideas:
- MR Bags, Visual Aids, LBLs, Notepads
- Informational leaflets with dosage & benefits
- WhatsApp creatives and digital flipbooks
Regulatory and Legal Compliance
- Label Claims: Must not mention unverified therapeutic effects
- Statutory Declarations: Must include Schedule H warning
- Pharmacovigilance: Maintain a record of adverse reactions and batch recalls
- Product Liability: Ensure insurance coverage if applicable
FAQs- Nimesulide and Paracetamol Tablets:
1. What is the third-party manufacturing of Nimesulide and Paracetamol Tablets?
It is outsourcing the production of tablets under your brand name from a licensed pharmaceutical manufacturer.
2. What documents are needed to start third-party manufacturing?
Drug License, GST, PAN, and LOI (Letter of Intent).
3. What is the current price of Nimesulide and Paracetamol Tablets for third-party manufacturing?
Approx. ₹3.5–₹4 per box, depending on packaging and quantity.
4. How long does manufacturing take?
Typically 30-35 days for the first order, including packaging development.
5. Can I customize the packaging design?
Yes, most manufacturers allow custom branding and artwork approval.
6. Is this product allowed for over-the-counter (OTC) sale?
No, it is a Schedule H prescription-only medicine.
7. Are stability reports necessary?
Yes, for regulatory and quality assurance purposes.
