Description

Methylprednisolone Tablets (4mg / 8mg / 16mg / 32mg)

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 Methylprednisolone Tablets in India. Methylprednisolone is a potent synthetic Corticosteroid (Glucocorticoid) with strong anti-inflammatory and immunosuppressive properties. It is widely prescribed for treating severe allergic reactions, asthma flare-ups, rheumatoid arthritis, and autoimmune conditions like Lupus (SLE).

We offer Contract Manufacturing (Third Party) services for this high-potency hormone. Methylprednisolone is approximately 20% more potent than standard Prednisolone and has less tendency to cause salt retention (edema). Our WHO-GMP certified facility in Mumbai utilizes specialized containment suites to handle potent hormones, ensuring zero cross-contamination. We produce high-precision tablets with excellent content uniformity. Healthy Inc manages the export logistics, supplying hospitals and pharmacy chains across the USA, Europe, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision dosing is critical for hormonal therapy.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Since Methylprednisolone is a potent drug (active in milligram doses), we use High-Shear Granulation and Geometric Blending techniques. This ensures that every single tablet contains exactly the labeled amount (e.g., 4mg), preventing dangerous under-dosing or over-dosing.

  • Containment: As a steroid, cross-contamination with other products must be strictly avoided. We manufacture this product in Dedicated HVAC Zones with HEPA filtration to capture airborne dust.

  • Dissolution: We optimize the tablet hardness and disintegrants to ensure the drug releases rapidly in the stomach for quick relief of inflammation.

• The Exporter: Healthy Inc

  • Dose Packs: We offer specialized packaging configurations, such as “Dose Paks” (Tapering Packs), which help patients follow the complex 6-day tapering schedule often prescribed by doctors.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 15 minutes (Immediate Release).

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

• Related Substances: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Methylprednisolone?

It suppresses the immune system’s “over-reaction.”

• Mechanism: It mimics the action of cortisol (a natural hormone). It enters cells and binds to glucocorticoid receptors, switching off the genes that produce inflammatory chemicals (like prostaglandins and leukotrienes) and suppressing the migration of white blood cells.

• Key Indications:

  • Respiratory: Acute Asthma attacks, COPD exacerbations.

  • Autoimmune: Rheumatoid Arthritis, Lupus, Multiple Sclerosis.

  • Allergy: Severe allergic reactions (anaphylaxis, angioedema).

  • Dermatology: Severe psoriasis or eczema.

• Advantage: It has less mineralocorticoid activity (less salt/water retention) than Prednisolone or Hydrocortisone, making it safer for patients with heart conditions or high blood pressure.

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 Methylprednisolone Tablets?

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

• Q: Is it Medrol?

  A: Medrol is the brand name (Pfizer). We manufacture the Generic Equivalent (Methylprednisolone), which works exactly the same way.

• Q: Can I stop taking it suddenly?

  A: NO. If you have taken it for more than a few days, you must “taper” off (reduce the dose slowly). Stopping suddenly can cause an “Adrenal Crisis” (fatigue, nausea, low BP) because your body has stopped making its own cortisol.

• Q: Does it cause weight gain?

  A: Yes. Long-term use can cause increased appetite and fluid retention (“Moon Face”). This usually reverses after stopping the medication.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Range: 4mg to 48mg per day, depending on disease severity.

• Tapering: Essential for courses longer than 5 days.

• Administration: Take with food or milk to reduce stomach irritation. Best taken in the morning (to mimic the body’s natural rhythm).

9. Side Effects and Precautions

• Immune Suppression: Increased risk of infections (fungal, viral). Avoid live vaccines.

• Endocrine: Hyperglycemia (high blood sugar), adrenal suppression, Cushing’s syndrome (long-term).

• Bone Health: Long-term use can lead to Osteoporosis. Calcium/Vitamin D supplements are often recommended.

• Gastric: Risk of peptic ulcers (especially if taken with NSAIDs).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.