Description

Mebeverine Tablets (135mg)

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 Mebeverine Hydrochloride Tablets in India. Mebeverine is a highly effective Musculotropic Antispasmodic used primarily for the symptomatic treatment of Irritable Bowel Syndrome (IBS) and chronic abdominal cramping. Unlike older antispasmodics (like Atropine or Dicyclomine), Mebeverine acts directly on the gut muscles without affecting the nervous system, meaning it does not cause anticholinergic side effects like dry mouth, blurred vision, or urinary retention.

We offer Contract Manufacturing (Third Party) services for this high-demand gastrointestinal drug. Mebeverine has an intensely bitter taste. Our WHO-GMP certified facility in Mumbai utilizes traditional Sugar Coating or advanced Flavor-Masked Film Coating technologies to ensure the tablet is palatable and easy to swallow. Healthy Inc manages the export logistics, supplying pharmacy chains and gastroenterology clinics across the UK, Middle East, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Targeting the gut without side effects.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Sugar Coating Excellence: The classic 135mg formulation is traditionally sugar-coated to completely mask the bitter taste of the API and protect it from moisture. We possess dedicated sugar-coating pans and polishing drums to achieve the high-gloss, elegant finish required for this product.

  • Controlled Release (SR) Capability: While 135mg is the standard release tablet, we also have the capability to manufacture 200mg Sustained Release (SR) formulations (often capsules or matrix tablets) using hydrophilic polymers to allow for twice-daily dosing.

  • Direct Compression: For film-coated variants, we use direct compression compatible excipients to ensure tablet hardness and stability.

• The Exporter: Healthy Inc

  • Market-Specific Packaging: We offer packaging that complies with specific regional requirements, such as Calendar Packs to help IBS patients track their daily dosage compliance.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes (for immediate release).

• Assay: We confirm the potency is strictly within 95-105% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products (veratric acid derivatives) to ensure safety.

5. Why Use Mebeverine?

It relaxes the spasm without freezing the gut.

• Mechanism: Mebeverine is “Musculotropic,” meaning it acts directly on the smooth muscle cells of the colon. It blocks Sodium (Na+) and Calcium (Ca2+) channels, preventing the muscle from contracting excessively (spasm) while still allowing normal gut motility (peristalsis).

• Key Indications:

  • IBS (Irritable Bowel Syndrome): Relieves stomach pain, cramps, bloating, and gas.

  • Chronic Irritable Colon: Spastic colitis, mucous colitis.

  • Abdominal Colic: Spasms caused by gastrointestinal disorders.

• Advantage: Ideal for patients with Glaucoma or Prostate Hypertrophy (who cannot take other antispasmodics) because it has no atropine-like side effects.

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 Mebeverine Tablets?

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

• Q: Is it Colofac?

  A: Colofac is the brand name (Abbott/Viatris). We manufacture the Generic Equivalent (Mebeverine HCl), which acts exactly the same.

• Q: When should I take it?

  A: It works best when taken 20 minutes before a meal. This allows the drug to be active in your system when the food triggers the gut muscles to contract.

• Q: Is it safe for long-term use?

  A: Yes. IBS is a chronic condition, and Mebeverine is generally safe for long-term management as prescribed by a doctor.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults & Children (10+ years): 135mg (one tablet) three times daily.

• Maintenance: Dose can be slowly reduced after symptoms are controlled.

• Administration: Swallow whole with water (do not chew because of the bitter taste). Take 20 mins before meals.

9. Side Effects and Precautions

• Allergic Reactions: Rare skin rash, urticaria, or angioedema.

• Systemic Effects: extremely rare (dizziness, headache) because it stays mostly in the gut.

• Pregnancy: Safety is not fully established; usually avoided unless necessary.

• Porphyria: Contraindicated in patients with acute porphyria.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep container tightly closed.