Description

Levamisole Tablets (50mg / 150mg)

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 Levamisole Hydrochloride Tablets in India. Levamisole is a dual-acting pharmaceutical agent. Primarily known as a potent Anthelmintic (Deworming Agent) for the treatment of Roundworm (Ascaris lumbricoides) and Hookworm infestations, it is also widely used as an Immunomodulator in the management of frequent relapsing Nephrotic Syndrome in children and as an adjuvant therapy in certain cancers (e.g., Colon Cancer) to boost the immune system.

We offer Contract Manufacturing (Third Party) services for this versatile drug. Levamisole is sensitive to moisture and has a distinct metallic taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating to mask the taste and specialized moisture-protective packaging to ensure stability. Healthy Inc manages the export logistics, supplying pediatric clinics, oncology centers, and government health programs across Southeast Asia, Africa, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Balancing potency with safety.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Levamisole HCl is intensely bitter and can cause nausea if dissolved in the mouth. We use a high-quality HPMC Film Coating to ensure the tablet is swallowed intact, improving compliance especially in pediatric patients treating Nephrotic Syndrome.

  • Content Uniformity: For immunomodulatory use, dosing must be precise to avoid toxicity (agranulocytosis). We use automated granulation and compression systems to ensure every tablet contains exactly 50mg or 150mg.

  • Stability: We process the drug in humidity-controlled zones to prevent degradation, ensuring the API remains active for the full 3-year shelf life.

• The Exporter: Healthy Inc

  • Clinical Packaging: We offer specific packaging configurations for different therapies—bulk packs for single-dose deworming campaigns and blister packs for chronic immunomodulation therapy.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes.

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

• Impurity Profiling: We strictly monitor for related substances to ensure safety, particularly for long-term users.

5. Why Use Levamisole?

It paralyzes worms and wakes up the immune system.

• Mechanism (Deworming): It acts as a nicotinic acetylcholine receptor agonist. This causes spastic paralysis of the worm’s muscles. The paralyzed worms are then expelled naturally by the intestine.

• Mechanism (Immunity): It restores depressed immune function by stimulating the formation of antibodies and enhancing the activity of T-cells and phagocytes (white blood cells that eat bacteria).

• Key Indications:

  • Ascariasis (Roundworm): Highly effective single-dose treatment.

  • Hookworm Infection: Effective against Ancylostoma duodenale.

  • Nephrotic Syndrome: Used to maintain remission in steroid-dependent cases in children.

  • Adjuvant Cancer Therapy: (Historical/Specific use) Combined with 5-FU for colon cancer.

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 Levamisole Tablets?

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

• Q: Is it Ergamisol?

  A: Ergamisol was a brand name (Janssen). We manufacture the Generic Equivalent (Levamisole HCl).

• Q: Is it safe for long-term use?

  A: Caution Required. While safe for single-dose deworming, long-term use (for immunity) carries a risk of Agranulocytosis (severe drop in white blood cells). Regular blood tests are mandatory.

• Q: Can I drink alcohol with it?

  A: NO. It can cause a “Disulfiram-like reaction” (flushing, nausea, vomiting) if taken with alcohol. Avoid alcohol during treatment.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Ascariasis (Adults): 150mg as a single dose.

• Ascariasis (Children): 3mg/kg body weight as a single dose.

• Nephrotic Syndrome: 2.5 mg/kg on alternate days (as per specialist protocol).

• Administration: Swallow whole with a little water. Best taken after a light meal.

9. Side Effects and Precautions

• Hematologic: Warning: Risk of Agranulocytosis, Leukopenia, and Thrombocytopenia with chronic use. Monitor CBC regularly.

• CNS: Dizziness, headache, or insomnia.

• Gastrointestinal: Nausea, vomiting, metallic taste.

• Skin: Rash or dermatitis.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.