Description

Ranitidine Tablets (150mg / 300mg)

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 Ranitidine Tablets in India. Ranitidine is a classical H2-Receptor Antagonist (H2 Blocker) historically used for the treatment of Peptic Ulcers, Gastroesophageal Reflux Disease (GERD), and hypersecretory conditions like Zollinger-Ellison syndrome.

Note: Due to global regulatory updates regarding NDMA impurities, Healthy Life Pharma strictly adheres to the latest safety guidelines. We manufacture this product only for markets where it remains approved and regulatory compliant, utilizing low-nitrite manufacturing processes to ensure safety.

We offer Contract Manufacturing (Third Party) services for this gastrointestinal medication. Our WHO-GMP certified facility in Mumbai utilizes advanced film-coating technologies to ensure stability and mask the bitter taste of the drug. Healthy Inc manages the export logistics, supplying compliant markets across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Safety and stability are paramount given the molecule’s sensitivity.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • NDMA Risk Mitigation: We strictly source Active Pharmaceutical Ingredient (API) from certified vendors with proven low-nitrite levels. Our manufacturing process minimizes heat exposure and avoids nitrite-containing excipients to prevent the formation of N-Nitrosodimethylamine (NDMA).

  • Moisture Protection: Ranitidine is hygroscopic and light-sensitive. We manufacture in controlled humidity environments to prevent degradation (darkening of tablets).

  • Film Coating: We use a robust Opadry Film Coating to protect the core from light and moisture, ensuring the tablet remains stable and effective throughout its shelf life.

• The Exporter: Healthy Inc

  • Protective Packaging: We utilize Alu-Alu Blisters or high-barrier Strip packs to provide maximum protection against environmental factors during export transit.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• NDMA Testing: Every batch is rigorously tested for NDMA impurities using LC-MS/MS to ensure it meets the strict limits set by international regulatory bodies.

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes for rapid symptom relief.

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

5. Why Use Ranitidine?

It provides effective acid suppression.

• Mechanism: It competitively inhibits histamine at the H2-receptors of the gastric parietal cells. This reduces both the volume and the acid concentration of gastric juice.

• Key Indications:

  • Duodenal & Gastric Ulcers: Promotes healing of ulcers.

  • GERD: Relieves heartburn and acid reflux.

  • Hypersecretory Conditions: Zollinger-Ellison syndrome.

  • Prophylaxis: Prevention of stress ulcers and aspiration pneumonitis (Mendelson’s syndrome) before surgery.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (including NDMA risk assessment data) 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 Ranitidine Tablets?

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

• Q: Is it safe to use?

  A: We manufacture strictly according to current safety guidelines, ensuring NDMA levels are below acceptable limits. However, regulatory status varies by country; please check your local regulations.

• Q: How is it different from Omeprazole?

  A: Ranitidine is an H2 Blocker (works within an hour, lasts ~12 hours). Omeprazole is a PPI (takes longer to start, but effects last ~24 hours and are stronger). Ranitidine is often used for milder, occasional heartburn.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Active Ulcer: 150mg twice daily or 300mg once daily at bedtime.

• GERD: 150mg twice daily.

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Headache, constipation, diarrhea, and nausea.

• Hepatic: Rare reversible hepatitis.

• Hematologic: Rare cases of thrombocytopenia/leukopenia.

• Renal Impairment: Dosage adjustment required in severe kidney disease.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture. (Tablets discolor easily if exposed).