Description

Itopride Tablets (50mg)

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 Itopride Hydrochloride Tablets in India. Itopride is a novel, dual-acting Prokinetic Agent used for the treatment of Functional Dyspepsia (chronic indigestion) and other gastrointestinal motility disorders. Unlike older prokinetics, Itopride is unique because it effectively accelerates gastric emptying without causing severe cardiovascular or neurological side effects.

We offer Contract Manufacturing (Third Party) services for this high-demand gastroenterology drug. Itopride has an intensely bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to completely mask the bitterness, ensuring patient compliance. Healthy Inc manages the export logistics, supplying pharmacy chains and gastro-clinics across Southeast Asia, Latin America, the Middle East, and CIS countries.

2. Product Specifications

3. Manufacturing Technology

Safety and efficacy through precision formulation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Dual-Action Formulation: We design the tablet to release the drug consistently to support its dual mechanism of action (Dopamine antagonism and AChE inhibition).

  • Taste Masking: The raw API is extremely bitter. We use a specialized HPMC-based Film Coating that creates a barrier, preventing the patient from tasting the bitterness during swallowing.

  • Stability: We use high-grade excipients (like lactose monohydrate and corn starch) to ensure the tablet remains stable and does not degrade in tropical climates.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: To guarantee superior shelf-life and protection against humidity, we often recommend Alu-Alu Cold Form Blisters for export markets with high humidity.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 30 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 over the 3-year shelf life.

5. Why Use Itopride?

The safest prokinetic on the market.

• Mechanism: It has a unique Dual Mechanism:

  1. Dopamine D2 Antagonist: Blocks dopamine receptors in the gut to stop nausea.

  2. Acetylcholinesterase (AChE) Inhibitor: Prevents the breakdown of acetylcholine, increasing the force of stomach contractions.

• Key Indications:

  • Functional Dyspepsia: Relieves sensation of bloating, early satiety (feeling full quickly), and upper abdominal pain.

  • Gastroparesis: Delays in stomach emptying (often in diabetics).

  • Anorexia: Improves appetite in patients with digestive issues.

• Major Advantage: Unlike Cisapride (banned for heart risks) or Metoclopramide (causes brain side effects), Itopride does not cross the blood-brain barrier and does not cause QT prolongation (heart rhythm issues). It is extremely safe.

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 Itopride Tablets?

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

• Q: Is it Ganaton?

  A: Ganaton is the brand name (Abbott). We manufacture the Generic Equivalent (Itopride HCl), which works exactly the same way.

• Q: Does it cause tremors (Parkinson-like symptoms)?

  A: No. Unlike Metoclopramide or Levosulpiride, Itopride rarely affects the brain, so the risk of tremors (extrapyramidal symptoms) is negligible.

• Q: When should I take it?

  A: It is strictly taken before meals (usually 3 times a day) to help the stomach process the food you are about to eat.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 50mg three times daily.

• Timing: Take 15-30 minutes before breakfast, lunch, and dinner.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Gastrointestinal: Mild diarrhea or abdominal pain (due to increased motility).

• Endocrine: Rarely causes elevated prolactin levels (Gynecomastia or Galactorrhea), but less common than with other drugs.

• Allergy: Rash or itching (rare).

• Pregnancy: Safety is not established; use only if clearly necessary.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.