Description

Famotidine Tablets (20mg / 40mg)

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 Famotidine Tablets in India. Famotidine is a potent, long-acting Histamine-2 (H2) Receptor Antagonist used to inhibit stomach acid production. It is a first-line therapy for the treatment of Duodenal Ulcers, Gastric Ulcers, and Gastroesophageal Reflux Disease (GERD). It is often preferred over older H2 blockers (like Cimetidine) because it has fewer drug interactions and does not cause anti-androgenic side effects.

We offer Contract Manufacturing (Third Party) services for this high-volume digestive aid. While Famotidine is stable, it has a bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to mask the taste and ensure the tablet is easy to swallow. Healthy Inc manages the export logistics, supplying pharmacies, hospitals, and OTC brands across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precise acid control.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Film Coating: The active ingredient is intensely bitter. We use a specialized Opadry coating system that provides a smooth, tasteless barrier, improving patient compliance, especially for those taking the medication daily for chronic reflux.

  • Direct Compression: Famotidine has favorable flow properties. We use direct compression technology which minimizes heat and moisture exposure during manufacturing, ensuring the chemical stability of the drug remains high throughout its 3-year shelf life.

  • Content Uniformity: We ensure rigorous blend uniformity testing so that every 20mg tablet delivers the exact dose required to suppress nocturnal acid secretion.

• The Exporter: Healthy Inc

  • OTC & Rx Packs: We are equipped to manufacture both small “Convenience Packs” (e.g., 10 tablets) for Over-the-Counter heartburn relief and large “Hospital Packs” (500s/1000s) for institutional use.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

5. Why Use Famotidine?

Stops the acid trigger at the source.

• Mechanism: Famotidine competitively blocks Histamine (H2) receptors located on the parietal cells of the stomach lining. Normally, histamine stimulates these cells to pump acid. By blocking the signal, Famotidine reduces both the volume and concentration of gastric acid.

• Key Indications:

  • Duodenal/Gastric Ulcer: Promotes healing by reducing acid irritation.

  • GERD: Relieves heartburn and acid regurgitation.

  • Zollinger-Ellison Syndrome: Controls massive acid overproduction caused by tumors (requires high doses).

  • Stress Ulcer Prophylaxis: Used in hospitalized patients to prevent ulcers.

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 Famotidine Tablets?

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

• Q: Is it Pepcid?

  A: Pepcid is the brand name (Merck). We manufacture the Generic Equivalent (Famotidine), which is bioequivalent.

• Q: Is it better than Omeprazole?

  A: Different Uses. Famotidine works faster (within 1 hour) but is less potent. Omeprazole (a PPI) takes longer to work but stops acid more completely. Famotidine is often preferred for mild symptoms or “on-demand” relief.

• Q: Can I take it with food?

  A: Yes. It can be taken with or without food. Taking it before the evening meal or at bedtime is common to stop acid at night.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Duodenal Ulcer: 40mg once daily at bedtime OR 20mg twice daily for 4-8 weeks.

• GERD: 20mg twice daily for up to 6 weeks.

• Maintenance: 20mg once daily at bedtime.

• Renal Impairment: Dose reduction (to 20mg every other day) is required if Creatinine Clearance is < 50 mL/min.

9. Side Effects and Precautions

• CNS: Headache, dizziness. (Confusion/delirium can occur in elderly patients with poor kidney function—monitor closely).

• Gastrointestinal: Constipation or diarrhea.

• Cardiac: Rare arrhythmias (QT prolongation) in patients with kidney failure.

• Tolerance: Unlike PPIs, tolerance (loss of effect) can develop with long-term continuous use.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.