Description

Ivermectin Tablets (3mg / 6mg / 12mg)

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 Ivermectin Tablets in India. Ivermectin is a Nobel Prize-winning Broad-Spectrum Anti-Parasitic Agent. It is the drug of choice for treating a wide range of neglected tropical diseases, including River Blindness (Onchocerciasis), Strongyloidiasis (Threadworm), Scabies, and Lymphatic Filariasis (Elephantiasis).

We offer Contract Manufacturing (Third Party) services for this essential public health medicine. Ivermectin is practically insoluble in water, which poses a bioavailability challenge. Our WHO-GMP certified facility in Mumbai utilizes advanced Solid Dispersion Technology and Micronization to ensure the drug dissolves effectively in the gut for maximum absorption. Healthy Inc manages the export logistics, supplying mass drug administration (MDA) programs, NGOs, and hospitals across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Making an insoluble drug bioavailable.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Solid Dispersion: Pure Ivermectin powder resists dissolving in water. We use solid dispersion techniques (melting the drug with a carrier polymer) to lock the drug in an amorphous state, drastically improving its solubility and bioavailability in the human body.

  • Micronization: For conventional tablets, we use air-jet milled API (< 5 microns) to increase surface area.

  • Dispersible Tablets (DT): We manufacture rapid-dispersing tablets for pediatric or geriatric use, which disintegrate in a spoonful of water in under 3 minutes.

• The Exporter: Healthy Inc

  • Mass Administration Packs: For government tenders (like Scabies or Filariasis control), we offer cost-optimized 4-tablet or single-dose blister packs to simplify distribution in field settings.

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.

• Isomer Ratio: Ivermectin is a mixture of two homologs (H2B1a and H2B1b). We strictly control this ratio to meet USP specifications.

5. Why Use Ivermectin?

It paralyzes the parasite’s muscles.

• Mechanism: Ivermectin binds selectively to glutamate-gated chloride channels found in nerve and muscle cells of invertebrates. This binding opens the channels, causing an influx of chloride ions. This hyperpolarizes the cell, leading to paralysis and death of the parasite. Importantly, it does not bind to human cell channels (which are protected by the blood-brain barrier), making it safe for humans.

• Key Indications:

  • Onchocerciasis (River Blindness): Kills the microfilariae in the skin/eyes.

  • Strongyloidiasis: Cure rate >90% for intestinal threadworm.

  • Scabies: Oral treatment for severe or crusted scabies (when creams fail).

  • Lymphatic Filariasis: Used in combination with Albendazole to stop transmission.

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 Ivermectin Tablets?

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

• Q: Is it Stromectol?

  A: Stromectol is the brand name (Merck). We manufacture the Generic Equivalent (Ivermectin), which acts exactly the same.

• Q: How do I take it for worms/scabies?

  A: It is usually taken as a Single Dose on an empty stomach with water. The dose depends on your body weight (approx. 200 mcg/kg).

• Q: Does it cause the “Mazotti Reaction”?

  A: Yes. When treating River Blindness, the death of thousands of microfilariae can cause an allergic reaction (fever, rash, swollen lymph nodes). This is a sign the drug is working but requires medical monitoring.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Strongyloidiasis: 200 mcg/kg (Single Dose).

• Onchocerciasis: 150 mcg/kg (Single Dose), repeated every 6-12 months.

• Scabies: 200 mcg/kg (Single Dose), repeated after 14 days.

• Administration: Take with a full glass of water on an empty stomach (1 hour before breakfast).

9. Side Effects and Precautions

• Mazotti Reaction: (In Onchocerciasis patients) Pruritus, rash, fever, lymphadenopathy, and arthralgia.

• Neurological: Dizziness or vertigo (rare).

• Pregnancy: Safety is not established. Avoid if possible.

• Loa Loa: Warning: Do not use in patients with high Loa loa (Eye Worm) loads, as it can cause serious encephalopathy.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light. (Keep in the carton).