Description

Diclofenac Potassium & Paracetamol Tablets

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Specifications (Quick Scan) | Parameter | Specification | | :— | :— | | Generic Name | Diclofenac Potassium + Paracetamol (Acetaminophen) | | Dosage Form | Film Coated Tablet / Bilayer Tablet | | Strength | Diclofenac Potassium 50mg + Paracetamol 325mg / 500mg | | Pharmacopoeial Standard | In-House / BP / USP Compliant | | Therapeutic Class | NSAID + Analgesic/Antipyretic | | Shelf Life | 36 Months | | Packaging | 10×10 Alu-Alu / Blister / Bulk Jar (1000s) | | Regulatory Status | Approved FDC (Fixed Dose Combination) |

2. Manufacturing & Export Structure Our operations are divided to ensure maximum manufacturing quality and seamless export logistics:

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Role: Production, Quality Control (QC), and Regulatory Compliance.

  • Facility: WHO-GMP and ISO 9001:2015 certified plant in Mumbai/Palghar.

  • Responsibility: Ensures every tablet meets IP/BP/USP standards using automated Rapid Mixer Granulators (RMG) and HPLC testing.

• The Global Marketing Division: Healthy Inc

  • Role: International Business, Logistics, and Client Support.

  • Responsibility: Healthy Inc acts as the exclusive marketing arm, handling export documentation (COPP, Shipping), client negotiations, and supply chain management. This ensures international buyers get factory-direct pricing with professional export service.

3. Quality Assurance (Technical)

• Safety Testing: Healthy Life Pharma utilizes strict limit tests for 4-aminophenol (Paracetamol impurity) and ensures <0.2% related substances.

• Dissolution: Target release >85% in 30 minutes for rapid onset of action.

• Stability: Validated for Zone IVb (Hot & Humid climates), ensuring the product remains stable during sea freight.

4. Mechanism of Action & Indications This formulation combines two synergistic agents for superior pain management:

• Diclofenac Potassium (50mg): The potassium salt dissolves faster than sodium, inhibiting COX-1 and COX-2 enzymes rapidly to block inflammation.

• Paracetamol (Acetaminophen): Acts centrally on the hypothalamus to reduce fever and elevate the pain threshold.

Key Indications:

• Acute Musculoskeletal Pain (Sprains, Strains).

• Post-Operative Inflammation & Dental Pain.

• Severe Migraine (Due to rapid absorption of Potassium salt).

5. Export & Regulatory Documentation Through Healthy Inc, we provide full support for global registration:

• Dossier: CTD / eCTD / ACTD formats.

• Certificates: Free Sale Certificate (FSC), COPP (Certificate of Pharmaceutical Product).

• Logistics: FOB Mumbai / CIF (Any Global Port).

6. FAQ (Clarifying the Companies)

• Q: Who manufactures the product?

  • A: The product is manufactured by Healthy Life Pharma Pvt. Ltd. at our WHO-GMP certified facility in Mumbai.

• Q: Who should I contact for export orders?

  • A: Please contact Healthy Inc. As the marketing division, Healthy Inc handles all B2B inquiries, pricing, and shipping to ensure a smooth transaction.

• Q: Can I get the product in my own brand (Private Label)?

  • A: Yes, Healthy Inc facilitates Contract Manufacturing (CMO) where Healthy Life Pharma manufactures the product under your brand name.