Description

Prednisolone Tablets (5mg / 10mg / 20mg / 40mg)

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 Prednisolone Tablets in India, catering to both global exports and Contract Manufacturing (Third Party) requirements. This systemic corticosteroid is widely used to treat inflammation, allergies, and autoimmune disorders.

We produce high-purity tablets that ensure precise dosage delivery. Our facility adheres to strict WHO-GMP standards, making us a preferred partner for government tenders and hospital supplies. Therefore, we guarantee consistent efficacy and safety. Healthy Inc manages our global exports and logistics from our Mumbai facility to the world.

2. Product Specifications

3. Manufacturing Prednisolone Tablets

We divide our operations to ensure specialized focus and quality assurance.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.First, Healthy Life Pharma handles the core manufacturing. We operate a WHO-GMP certified plant in Mumbai. Since corticosteroids are potent drugs, we follow strict Containment Protocols. This prevents cross-contamination with other products. We use High-Shear Granulation to ensure the active ingredient is evenly distributed. This is critical for ensuring that every 5mg tablet contains exactly 5mg of Prednisolone, preventing under-dosing or overdose.
• The Exporter: Healthy IncSecond, Healthy Inc manages international trade. This division handles logistics for Prednisolone Tablets. We supply hospitals and pharmacies globally. We are experienced in handling the regulatory documentation required for steroid exports. We ensure our packaging protects the product from moisture, which can degrade the active ingredient.

4. Quality Assurance

We test every batch rigorously to ensure compliance with BP/USP/IP standards.

• Content Uniformity: We test individual tablets to confirm dosage precision. This is vital for maintaining stable steroid levels in the patient’s blood.

• Dissolution: We test how the tablet releases the drug. Fast release is important for acute allergic reactions.

• Related Substances: We monitor impurities to ensure the product remains stable and safe throughout its shelf life.

5. Why Use Prednisolone Tablets?

This drug is a powerful anti-inflammatory and immunosuppressant.

• Mechanism: It mimics the effects of cortisol, a hormone produced by the adrenal glands. It suppresses the immune system’s inflammatory response.

• Effect: It reduces swelling, redness, and allergic reactions rapidly.

• Key Indications:

  • Respiratory: Treatment of Asthma exacerbations and COPD.

  • Autoimmune: Management of Rheumatoid Arthritis, Lupus (SLE), and Vasculitis.

  • Allergy: Treatment of severe allergic reactions (Anaphylaxis, Angioedema).

  • Other: Treatment of Inflammatory Bowel Disease (IBD) and certain cancers (Leukemia).

6. Export and Regulatory Support

We understand that registration is the first step in B2B partnership. We provide complete documentation to support your local registration:

• Dossier Support: We provide ready-to-file CTD and ACTD Dossiers.

• Certificates: We supply the Free Sale Certificate (FSC) and COPP (WHO-GMP).

• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

• Q: Who manufactures Prednisolone Tablets?A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
• Q: Is this the same as Prednisone?A: They are very similar, but Prednisolone is the active form that the body uses directly. Prednisone must be converted by the liver first.
• Q: Do you make Dispersible Tablets (DT)?A: Yes, we manufacture Dispersible Tablets, which are often preferred for pediatric use (e.g., Kidpred).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Highly variable depending on the condition. Ranges from 5mg to 60mg daily.

• Tapering: High doses must be reduced gradually (tapered) to prevent adrenal insufficiency. Do not stop abruptly.

• Administration: Take with food or milk to prevent stomach upset.

9. Side Effects and Precautions

• Common Side Effects: Increased appetite, weight gain, insomnia, and mood swings.

• Long-term Use: Prolonged use can cause Osteoporosis, Diabetes, Hypertension, and increased susceptibility to infection.

• Contraindications: Systemic fungal infections or hypersensitivity to Prednisolone.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.

• Keep out of reach of children.