Description

Paracetamol and Diclofenac Sodium Tablets (325mg/500mg + 50mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a leading Manufacturer of Paracetamol and Diclofenac Sodium Tablets in India. This potent Fixed-Dose Combination (FDC) is one of the most widely prescribed analgesics for the management of pain and inflammation associated with musculoskeletal disorders. It combines the antipyretic and analgesic action of Paracetamol with the strong anti-inflammatory properties of Diclofenac Sodium.

We offer Contract Manufacturing (Third Party) services for this high-volume formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced Enteric Coating Technology (for the Diclofenac component) or specialized film coating to protect the stomach lining and ensure targeted drug release. Healthy Inc manages the export logistics, supplying orthopedic clinics, hospitals, and pharmacies across Africa, Southeast Asia, and CIS countries.

2. Product Specifications

3. Manufacturing Technology

Balancing immediate relief with stomach protection.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Dual Release Profile: In advanced formulations, we ensure the Paracetamol dissolves immediately for quick pain relief, while the Diclofenac Sodium (which can irritate the stomach) is often formulated to resist gastric acid or buffered to minimize irritation.

  • Stability: Diclofenac Sodium is sensitive to moisture. We use Wet Granulation with specific binders that ensure hard, durable tablets that do not crumble during shipping but still disintegrate properly in the body.

  • Taste Masking: Diclofenac has a bitter, metallic taste. Our robust Film Coating (Opadry) completely masks this, ensuring patient compliance.

• The Exporter: Healthy Inc

  • Logistics: We use high-barrier PVC/PVDC Blisters or Alu-Alu packs to prevent moisture ingress, which is critical for maintaining the chemical stability of Diclofenac over the 3-year shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We simultaneously determine the precise content of Paracetamol and Diclofenac Sodium to ensure 100% label claim.

• Dissolution: We test for the release rate of both drugs. Paracetamol must release >85% in 30 minutes, while Diclofenac must meet specific release criteria depending on whether it is enteric-coated or plain.

• Related Substances: We strictly monitor for degradation products like 4-aminophenol and Diclofenac impurities (Indolinone).

5. Why Use Paracetamol + Diclofenac Sodium?

It attacks pain from two directions.

• Mechanism:

  • Paracetamol: Works in the brain to block pain signals and reduce fever.

  • Diclofenac Sodium: A potent NSAID that blocks COX-1 and COX-2 enzymes at the site of injury, reducing the production of prostaglandins that cause inflammation, swelling, and pain.

     

• Key Indications:

  • Arthritis: Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

  • Musculoskeletal Pain: Lower back pain, sprains, strains, and sports injuries.

  • Post-Operative Pain: Management of pain and swelling after surgery.

  • Dental Pain: Severe toothache and post-extraction inflammation.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Paracetamol Diclofenac Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is this safer than Diclofenac alone?

  A: Combining with Paracetamol allows for better pain relief, often permitting a lower dose of Diclofenac, which may reduce the risk of stomach ulcers compared to high-dose NSAID monotherapy.

• Q: Can I take this for a fever?

  A: Yes, both ingredients have antipyretic (fever-reducing) properties.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet 2 to 3 times daily after meals.

• Maximum Dose: Do not exceed 150mg of Diclofenac Sodium per day.

• Administration: Must be taken after food to prevent gastric irritation and ulcers.

9. Side Effects and Precautions

• Gastric Effects: The most common side effect is epigastric pain, nausea, and heartburn. Long-term use can cause peptic ulcers.

• Cardiovascular Risk: NSAIDs may increase the risk of heart attack or stroke in patients with pre-existing heart conditions.

• Renal Function: Use with caution in patients with kidney disease.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light and moisture.