Description

Metoclopramide Tablets (10mg)

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 Metoclopramide Hydrochloride Tablets in India. Metoclopramide is a powerful Antiemetic and Prokinetic Agent used globally to treat severe nausea and vomiting (caused by chemotherapy, radiation, or surgery) and to manage Diabetic Gastroparesis (delayed stomach emptying) and GERD.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Metoclopramide is sensitive to light. Our WHO-GMP certified facility in Mumbai utilizes specialized light-resistant packaging and formulation techniques to ensure the product remains stable. Healthy Inc manages the export logistics, supplying hospitals, oncology centers, and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stability and safety are the priorities.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Photosensitivity Protection: Metoclopramide degrades if exposed to direct light. We manufacture under controlled lighting conditions and recommend Opaque Blisters or Amber-colored packaging to ensure potency is maintained until the expiry date.

  • Content Uniformity: We use high-precision blending to ensure exact dosing (10mg), which is critical because overdosing can lead to severe neurological side effects (dystonia).

  • Rapid Disintegration: For antiemetics, speed is key. We formulate the tablet to break down rapidly in the stomach (< 15 minutes) to provide quick relief from nausea.

• The Exporter: Healthy Inc

  • Bulk Logistics: We offer optimized bulk packaging solutions (high-density jars) for hospital tenders, ensuring low freight costs per unit.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% release in 30 minutes.

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

• Related Substances: We strictly monitor for degradation products to ensure safety.

5. Why Use Metoclopramide?

It stops the vomiting signal and moves the stomach.

• Mechanism:

  1. Brain (CTZ): It blocks Dopamine D2 receptors in the Chemoreceptor Trigger Zone (CTZ) of the brain, stopping the nausea signal.

  2. Gut (Prokinetic): It increases the sensitivity of the stomach to Acetylcholine, causing the stomach muscles to contract and empty food into the intestine faster (treating gastroparesis).

• Key Indications:

  • Nausea/Vomiting: Chemotherapy-induced, post-operative, or migraine-associated.

  • Gastroparesis: Delays in stomach emptying due to diabetes.

  • GERD: Used when other drugs fail, to clear acid from the esophagus.

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 Metoclopramide Tablets?

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

• Q: Is it Reglan?

  A: Reglan is the brand name. We manufacture the Generic Equivalent (Metoclopramide HCl).

• Q: Can I take it for a long time?

  A: NO. It should generally not be used for longer than 12 weeks. Long-term use increases the risk of Tardive Dyskinesia (uncontrollable muscle movements).

• Q: Does it cause drowsiness?

  A: Yes. Drowsiness and fatigue are common. Do not drive after taking it.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 10mg, 30 minutes before meals and at bedtime.

• Max Dose: 40mg per day.

• Duration: Short-term use only (usually < 12 weeks).

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Tardive Dyskinesia: Black Box Warning: Risk of irreversible involuntary movements (face, tongue, limbs), especially in elderly women and with long-term use.

• EPS (Extrapyramidal Symptoms): Muscle spasms, tremors, or restlessness (akathisia). Treatable with diphenhydramine.

• Depression: Can worsen mental depression.

• Hypertension: May cause a spike in blood pressure in patients with pheochromocytoma.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Store in the original blister).