Diclofenac, Paracetamol and Chlorzoxazone Tablets fall under the category of muscle relaxants and pain relievers. These tablets are commonly prescribed for musculoskeletal pain, lower back pain, and sprains. The three active ingredients—Diclofenac (NSAID), Paracetamol (analgesic & antipyretic), and Chlorzoxazone (muscle relaxant)—work synergistically to provide quick and effective relief from inflammation, fever, and muscle spasms.

Due to an increase in cases of physical strain, arthritis, and sedentary lifestyles, the demand for combination pain relief therapies has surged. The Indian pain management market is growing steadily and is expected to reach INR 7,000+ crore in the coming years. For pharma startups and distributors, third-party manufacturing of Diclofenac, Paracetamol and Chlorzoxazone Tablets is far more scalable and cost-efficient than simply procuring PCD franchise products. It allows for better branding, profit margins, and market control.

Also read this: Aceclofenac, Paracetamol and Chlorzoxazone Tablets

Product Overview

• Composition: Diclofenac Sodium 50mg + Paracetamol 325mg + Chlorzoxazone 250mg
• Dosage Form: Film-coated tablets
• Strengths: As above
• Classification: Rx Drug (Prescription Only), falls under Schedule H as per the Drugs and Cosmetics Act, 1940

Uses and Benefits

• Reduces inflammation and pain
• Effective in treating muscle spasms
• Provides fast-acting relief in orthopedic and post-operative pain cases
• Commonly prescribed by orthopedic specialists, general practitioners, and physiotherapists

Third-Party Manufacturing Process for This Product

Here’s a simplified step-by-step guide:

1. Inquiry & Quotation: Share your requirement, composition, quantity (MOQ: 500 boxes)
2. Finalization of Brand Name and Design: Choose your brand, packaging style
3. Documentation Submission:
   • LOI (Letter of Intent)
   • Drug License (Form 20B & 21B)
   • GST Number
   • Company PAN and Aadhaar
4. Quotation Approval & Advance Payment
5. Artwork and Packaging Approval
6. Production and Testing: Usually takes 25–30 days
7. Dispatch and Delivery with proper batch documentation

Manufacturer’s Role

A professional manufacturer ensures:

• cGMP compliance
• On-time delivery
• Standardized batch production
• Stability and QC testing
• Proper packaging as per Schedule H and labeling guidelines

Quality & Compliance Considerations

• Certifications: WHO-GMP, ISO 9001:2015
• Stability Parameters: Real-time & accelerated stability studies
• Testing: API assay, disintegration, dissolution, microbial limits
• Labeling Requirements:
  • Mandatory Schedule H Warning: “Caution: Not to be sold without the prescription of a Registered Medical Practitioner”
  • Mfg/Exp date, batch no., MRP, Rx symbol, storage conditions
  • Manufacturer’s address and license no.

Cost and Investment Breakdown

• MOQ: 500 boxes
• Costing Structure (Approx):
  • Manufacturing: ₹1.10–₹1.50 per tablet
  • Packing: ₹0.50–₹0.70 per tablet
  • Testing & QC: ₹2,000–₹5,000 per batch
  • Freight & Logistics: As per location
  • GST: 12% on tablets

Tips for Cost Optimization

• Place higher MOQs for economies of scale
• Choose bulk packaging (e.g., Alu-Alu vs. Blister)
• Finalize stable branding to avoid repackaging costs

Choosing the Right Manufacturer

Shortlisting Criteria

• WHO-GMP certified facility
• Minimum 5 years of experience in muscle relaxant segment
• Transparent costing and documentation

Questions to Ask

• Are you WHO-GMP/ISO compliant?
• What’s your turnaround time?
• What tests are included in product QC?

Red Flags

• Hidden costs
• Lack of QC reports
• No clarity on delivery timelines

Marketing and Branding Strategy

• Packaging Design:
  • Highlight “Triple Action Pain Relief”
  • Use bold fonts and clear Rx symbols
  • Add your brand logo prominently
• Promotional Material Ideas:
  • MR detailing visual aids
  • MR bags, calendars, notepads
  • WhatsApp product catalogs
  • Patient education leaflets

Regulatory and Legal Compliance

• Label Claims must match DCGI-approved monographs
• Pharmacovigilance: Ensure adverse event reporting system is in place
• Maintain batch records and invoice copies for minimum 3 years
• Must comply with Drugs and Magic Remedies (Objectionable Advertisements) Act

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FAQs: Third Party Manufacturing of Diclofenac, Paracetamol and Chlorzoxazone Tablets