Description

Mebendazole Tablets (100mg / 500mg)

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 Mebendazole Tablets in India. Mebendazole is a broad-spectrum Anthelmintic (Deworming Agent) used globally to treat intestinal worm infections. It is the drug of choice for mixed infestations and is highly effective against Pinworms, Roundworms, Whipworms, and Hookworms.

We offer Contract Manufacturing (Third Party) services for this essential public health medicine. We manufacture both Chewable (orange/chocolate flavor) and Swallowable formulations. Mebendazole presents a unique manufacturing challenge: Polymorphism. Only specific crystal forms of the drug are effective. Our WHO-GMP certified facility in Mumbai utilizes advanced X-Ray Diffraction (XRD) validation to ensure we use the biologically active polymorph (Form C), ensuring the drug actually works. Healthy Inc manages the export logistics, supplying school deworming programs, NGOs, and Ministries of Health across Africa, Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Polymorph control is the difference between a cure and failure.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Polymorph Selection: Mebendazole exists in three crystal forms (A, B, and C). Polymorph A is practically ineffective in humans. We strictly source and validate Polymorph C, which has the optimal solubility and bioavailability required to kill parasites.

  • Micronization: The drug is poorly soluble in water. We use Air Jet Milling to micronize the API, increasing its surface area to ensure it dissolves sufficiently in the gut fluids to reach the worms.

  • Chewable Technology: For the 100mg and 500mg pediatric versions, we use specialized sweeteners and flavors to mask the chalky taste, ensuring high compliance in mass deworming campaigns for children.

• The Exporter: Healthy Inc

  • School Program Packaging: We offer cost-effective 1-tablet or 6-tablet blister packs specifically designed for single-dose mass administration programs in schools.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 120 minutes (as per specific USP/BP methods for this insoluble drug).

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

• Polymorph Verification: We perform regular checks to ensure no conversion to the inactive Polymorph A occurs during processing (e.g., due to heat from granulation).

5. Why Use Mebendazole?

It starves the worm without harming the host.

• Mechanism: Mebendazole binds to the tubulin protein of the parasite. This prevents the worm from forming microtubules, which are essential for absorbing glucose (sugar). The worm effectively starves to death and is expelled from the body.

• Key Indications:

  • Enterobiasis (Pinworm): Highly contagious, causes anal itching.

  • Ascariasis (Roundworm): Common in tropical climates.

  • Trichuriasis (Whipworm): Infects the large intestine.

  • Hookworm: Causes anemia.

• Safety Advantage: Very little of the drug is absorbed into the human bloodstream (<10%). It stays in the gut where the worms are, making it very safe with few systemic side effects.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (focusing on Polymorph C data) for 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 Mebendazole Tablets?

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

• Q: Is it Vermox?

  A: Vermox is the brand name (Janssen). We manufacture the Generic Equivalent (Mebendazole), which works exactly the same way.

• Q: Do I need to fast (starve) before taking it?

  A: NO. Unlike older dewormers, no fasting or laxatives are required. It can be taken with or without food. Chewable tablets should be chewed completely.

• Q: Is it safe for pregnancy?

  A: Avoid in 1st Trimester. While risk is low, it is generally recommended to avoid deworming agents in the first trimester unless the benefit outweighs the risk.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Pinworm: 100mg single dose. Repeat after 2 weeks (to kill hatched eggs).

• Roundworm/Whipworm/Hookworm: 100mg twice daily for 3 consecutive days OR 500mg Single Dose (mass treatment protocol).

• Administration: Chewable tablets must be chewed before swallowing. Uncoated tablets can be crushed and mixed with food for children.

9. Side Effects and Precautions

• Gastrointestinal: Transient abdominal pain and diarrhea (often due to the expulsion of dead worms).

• Rare: Rash, urticaria, or angioedema.

• Convulsions: Extremely rare risk in infants. Contraindicated in children under 1 year of age.

• Interactions: Avoid concurrent use with Metronidazole (risk of Stevens-Johnson Syndrome).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.