Description

Aceclofenac Tablets (100mg)

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 specialized Manufacturer of Aceclofenac Tablets in India. Aceclofenac is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) related to Diclofenac but with a superior safety profile. It is widely prescribed for the relief of pain and inflammation in chronic joint disorders such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

We offer Contract Manufacturing (Third Party) services for this high-demand analgesic. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to mask the bitter taste of the drug and ensure gastric stability. Aceclofenac is known for having better gastric tolerance (less stomach irritation) than older NSAIDs like Diclofenac, making it a preferred choice for long-term therapy. Healthy Inc manages the export logistics, supplying orthopedic clinics, hospitals, and pharmacies across Africa, Southeast Asia, CIS, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Creating a stable, fast-acting NSAID requires precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Direct Compression / Wet Granulation: We utilize optimized granulation techniques to ensure the tablet has the correct hardness and disintegration time. Aceclofenac is practically insoluble in water, so we use specific super-disintegrants and surfactants to ensure it dissolves rapidly in the intestine for quick pain relief.

  • Film Coating: Uncoated Aceclofenac has an unpleasant, bitter taste. We apply a high-quality Opadry Film Coating to ensure patient compliance and protect the tablet from moisture.

• The Exporter: Healthy Inc

  • Stability: Aceclofenac can degrade into Diclofenac if exposed to high heat and humidity. We recommend Alu-Alu Blisters for tropical climates to provide the highest barrier protection, ensuring the product remains stable over its 3-year shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test the release rate to ensure >85% of the drug is released within 30-45 minutes.

• Assay: We use HPLC to confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation impurities (like Diclofenac sodium) to ensure safety.

5. Why Use Aceclofenac?

It offers potent efficacy with reduced side effects.

• Mechanism: It inhibits the cyclooxygenase (COX) enzyme, specifically blocking the production of prostaglandins that cause pain and inflammation. It shows greater selectivity for COX-2 than COX-1, which is why it is gentler on the stomach lining compared to conventional NSAIDs.

• Key Indications:

  • Osteoarthritis: Relief of joint pain and stiffness.

  • Rheumatoid Arthritis: Reduces swelling and inflammation.

  • Ankylosing Spondylitis: Relieves back pain and stiffness.

  • Dental & Post-Operative Pain: Effective for acute pain management.

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 Aceclofenac Tablets?

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

• Q: Is Aceclofenac better than Diclofenac?

  A: Clinically, Aceclofenac is considered to have a better safety profile regarding gastrointestinal side effects (less acidity/ulcer risk) while providing similar pain relief.

• Q: Can I take this on an empty stomach?

  A: No. Like all NSAIDs, it should always be taken after food to prevent stomach irritation.

   

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 100mg taken twice daily (morning and evening).

• Maximum Dose: 200mg per day.

• Administration: Swallow whole with plenty of water. Do not chew or crush.

9. Side Effects and Precautions

• Common Side Effects: Indigestion, heartburn, nausea, and diarrhea.

• Cardiovascular: Use with caution in patients with uncontrolled hypertension or heart failure.

• Contraindications: Active peptic ulcer, severe heart failure, or hypersensitivity to Aspirin/NSAIDs.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light and moisture.