Description

Tinidazole Tablets (500mg / 1000mg)

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 Tinidazole Tablets in India. Tinidazole is a potent Antiprotozoal and Antibacterial Agent belonging to the nitroimidazole class (similar to Metronidazole). It is widely regarded as a superior alternative to Metronidazole due to its longer duration of action and better tolerability profile, often allowing for convenient single-dose treatments for various parasitic and anaerobic infections.

We offer Contract Manufacturing (Third Party) services for this high-demand anti-infective. Our WHO-GMP certified facility in Mumbai utilizes advanced film-coating technologies to effectively mask the naturally bitter taste of the drug, ensuring patient compliance. Healthy Inc manages the export logistics, supplying this essential medicine to hospitals, clinics, and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Improving compliance through better formulation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Tinidazole is intensely bitter. We apply a robust Opadry Film Coating to the tablet core. This coating prevents the tablet from dissolving on the tongue, masking the taste completely and making it easy to swallow.

  • High-Dose Compression: For the 1000mg (1g) strength, which is often used as a single dose, we use specialized high-pressure tooling to compress the large volume of powder into a streamlined, manageable tablet size (caplet shape).

  • Granulation: We use wet granulation to improve flow properties and ensure that the tablet disintegrates rapidly in the stomach for quick absorption.

• The Exporter: Healthy Inc

  • Packaging: We offer flexible packaging options, including 4-tablet combi-packs (specifically for single-dose treatments of Trichomoniasis or Giardiasis) which are popular in retail markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test the release profile to ensure >85% of the drug releases within 30 minutes, ensuring rapid onset of action.

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

• Related Substances: We strictly monitor for degradation products (like 2-methyl-5-nitroimidazole) to ensure safety over the 3-year shelf life.

5. Why Use Tinidazole?

It is more convenient and often better tolerated than Metronidazole.

• Mechanism: It penetrates the cell of the microorganism and damages its DNA structure, inhibiting synthesis and causing cell death. It targets protozoa and anaerobic bacteria.

• Key Indications:

  • Amoebiasis: Intestinal (dysentery) and hepatic (liver abscess) infection.

  • Giardiasis: Intestinal parasite causing diarrhea.

  • Trichomoniasis: A common sexually transmitted infection (STI).

  • Bacterial Vaginosis: Infection of the vagina.

  • Anaerobic Infections: Peritonitis, gynecological infections, and post-surgical prophylaxis.

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 Tinidazole Tablets?

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

• Q: How is it different from Metronidazole?

  A: Tinidazole has a longer half-life (12-14 hours vs. 6-8 hours for Metronidazole). This allows for Once-Daily Dosing or even Single-Dose cures, whereas Metronidazole often requires 3 doses a day for several days. Tinidazole also generally causes less nausea/metallic taste.

• Q: Can I drink alcohol?

  A: No. Like Metronidazole, Tinidazole can cause a “Disulfiram-like reaction” (severe vomiting, flushing, rapid heart rate) if mixed with alcohol. Avoid alcohol during treatment and for 72 hours after the last dose.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Trichomoniasis & Giardiasis: Typically a single dose of 2g (four 500mg tablets) taken once.

• Intestinal Amoebiasis: 2g per day for 3 days.

• Amoebic Liver Abscess: 2g per day for 3-5 days.

• Administration: Must be taken with food to minimize stomach upset.

9. Side Effects and Precautions

• Common Side Effects: Metallic taste, nausea, loss of appetite, and dark urine (harmless).

• Neurological: Rare risk of numbness or tingling (neuropathy) or seizures with prolonged use.

• Pregnancy: Contraindicated in the first trimester. Use only if clearly needed in 2nd/3rd trimesters.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.