Description

Etoricoxib Tablets (60mg / 90mg / 120mg)

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 Etoricoxib Tablets in India. Etoricoxib is a highly advanced Selective COX-2 Inhibitor (NSAID) designed to provide powerful pain relief with significantly lower risk of stomach ulcers compared to traditional NSAIDs like Diclofenac or Ibuprofen. It is the preferred choice for chronic conditions like Rheumatoid Arthritis and Osteoarthritis, and is uniquely indicated for the rapid relief of Acute Gouty Arthritis.

We offer Contract Manufacturing (Third Party) services for this modern analgesic. Unlike older NSAIDs, Etoricoxib requires precise formulation to ensure immediate bioavailability for acute pain while maintaining stability. Our WHO-GMP certified facility in Mumbai utilizes dedicated manufacturing suites to prevent cross-contamination and employs advanced Film Coating to ensure product stability and patient compliance. Healthy Inc manages the export logistics, supplying orthopedic centers and pharmacy chains across Europe, Southeast Asia, Latin America, and the Middle East (Note: Not marketed in the USA).

2. Product Specifications

3. Manufacturing Technology

Pain relief that protects the stomach.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Selective Action: Traditional NSAIDs block both COX-1 (stomach protection) and COX-2 (pain). Etoricoxib is engineered to block only COX-2. We ensure the active ingredient purity is maintained to preserve this selectivity ratio, which is the key to its superior safety profile.

  • Rapid Dissolution: For the 120mg Acute Gout dose, speed is critical. We utilize Super-Disintegrants (like Croscarmellose Sodium) to ensure the tablet disintegrates rapidly, providing pain relief in as little as 24 minutes.

  • Taste Masking: The API has a bitter taste. We apply a high-quality Opadry Film Coating to make the tablet easy to swallow and aesthetically pleasing.

• The Exporter: Healthy Inc

  • Differentiated Branding: We use distinct colors for each strength (e.g., 60mg Green, 90mg White, 120mg Teal) to help elderly patients and pharmacists easily distinguish between maintenance doses and acute doses.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Related Substances: We strictly monitor for synthetic impurities to ensure the drug remains safe for long-term use.

5. Why Use Etoricoxib?

Targeted relief for inflammatory pain.

• Mechanism: Etoricoxib selectively inhibits the Cyclooxygenase-2 (COX-2) enzyme isoform. By sparing the COX-1 enzyme, it allows the stomach lining to maintain its protective mucus layer, drastically reducing the risk of gastritis and ulcers common with other painkillers.

• Key Indications:

  • Osteoarthritis (60mg): Long-term management of joint pain and stiffness.

  • Rheumatoid Arthritis (90mg): Reduces inflammation and improves mobility.

  • Acute Gout (120mg): rapid relief of severe pain during gout attacks (limited to 8 days).

  • Post-Operative Dental Pain: Effective for short-term relief after dental surgery.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) 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 Etoricoxib Tablets?

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

• Q: Is it Arcoxia?

  A: Arcoxia is the brand name (Merck). We manufacture the Generic Equivalent (Etoricoxib), which works exactly the same way.

• Q: Is it safer for the stomach?

  A: Yes. Clinical trials show significantly fewer stomach ulcers with Etoricoxib compared to Diclofenac or Naproxen. However, caution is still advised for patients with a history of severe ulcers.

• Q: Can I take it if I have heart problems?

  A: Caution. Like all COX-2 inhibitors, Etoricoxib can slightly increase the risk of heart attack or stroke in high-risk patients. It is contraindicated in patients with uncontrolled hypertension or established heart disease.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Osteoarthritis: 30mg or 60mg once daily.

• Rheumatoid Arthritis / Ankylosing Spondylitis: 90mg once daily.

• Acute Gouty Arthritis: 120mg once daily (Max 8 days).

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Cardiovascular: Hypertension (high blood pressure) is a common side effect. Monitor BP regularly.

• Edema: Fluid retention/swelling in the legs.

• Gastrointestinal: Dyspepsia (though less than traditional NSAIDs).

• Liver: Rare elevations in liver enzymes.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.