In the pharmaceutical industry, Levamisole 40 mg is a unique molecule that serves a dual purpose as both an anthelmintic (anti-parasitic) and an immunomodulator. As a pharmacist and manufacturer, I view Levamisole as a versatile “old-school” drug that has found modern applications in specialized medicine, although its use as a dewormer has largely been superseded by newer agents like Albendazole in many regions.

Primary Clinical Uses

• Ascariasis (Roundworm): It is highly effective in treating infections caused by Ascaris lumbricoides. A single dose is often sufficient to paralyze the worms, which are then expelled naturally from the body.

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• Adjuvant Cancer Therapy: Historically used in combination with Fluorouracil (5-FU) to treat Stage III colon cancer after surgical resection.

• Nephrotic Syndrome: Used in pediatric medicine (often off-label) for steroid-dependent nephrotic syndrome to help maintain remission and reduce the need for high-dose steroids.

• Immunomodulation: It can “reset” a depressed immune system by stimulating T-cell function and macrophage activity, making it useful in certain chronic infections or autoimmune conditions.

Mechanism of Action: Paralyzing and Stimulating

Levamisole works differently depending on the target:

Anthelmintic Action: It acts as a nicotinic acetylcholine receptor agonist in the muscle of the parasite. This causes a continuous muscle contraction, leading to spastic paralysis of the worm. Once paralyzed, the worm loses its grip on the intestinal wall and is eliminated via peristalsis.

Immunomodulatory Action: It restores immune function by increasing the chemotaxis and phagocytosis of neutrophils and stimulating the proliferation of T-lymphocytes.

The Manufacturer’s Perspective: Technical & Export Details

From a production and global trade standpoint, Levamisole 40 mg requires careful regulatory and technical handling:

• Veterinary vs. Human Grade: As a manufacturer, we must strictly distinguish between human-grade and veterinary-grade (Levamisole is very common in livestock). Our WHO-GMP facility ensures the highest purity and adherence to BP/USP/IP monographs for human consumption.

• Side Effect Monitoring (Agranulocytosis): One of the primary reasons Levamisole use is restricted in some Western markets is the risk of agranulocytosis (a severe drop in white blood cells). In your eCTD Dossier and Product Information Leaflets (PIL), detailed blood monitoring instructions are essential for regulatory compliance.

• Stability for Global Trade: Levamisole Hydrochloride is relatively stable but must be protected from light. We utilize Alu-Alu or Amber-colored PVC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa and Southeast Asia).

• B2B & Public Health Tenders: This remains a high-volume product for deworming programs in specific developing markets. Our Mumbai facility provides the stability data and dossiers required for these government tenders.