Description

Metronidazole Tablets (200mg / 400mg / 500mg)

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 leading Manufacturer of Metronidazole Tablets in India. Metronidazole is a nitroimidazole antimicrobial that acts as the “Gold Standard” for Anaerobic Infections and Protozoal diseases. It is essential for treating conditions ranging from dental abscesses and surgical prophylaxis to severe gastrointestinal infections like Amebiasis and Giardiasis.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Metronidazole is characterized by an intensely bitter taste and sensitivity to light. Our WHO-GMP certified facility in Mumbai utilizes specialized Taste-Masking Film Coating technology to ensure patient compliance and prevent the tablet from dissolving in the mouth. Healthy Inc manages the export logistics, supplying government tenders, hospital chains, and NGOs across Africa, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Compliance and stability are the key drivers.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: The raw API is extremely bitter and can cause gagging. We use a robust HPMC-based Film Coating that completely seals the core, ensuring the patient tastes nothing until the tablet reaches the stomach.

  • Light Stability: Metronidazole darkens (turns reddish-brown) if exposed to light due to oxidation. We manufacture under controlled lighting and use opaque packaging materials to maintain the pristine white appearance of the tablet.

  • Hardness Control: We optimize compression force to ensure the tablets are hard enough for bulk transport but disintegrate rapidly (< 15 mins) to fight acute infections quickly.

• The Exporter: Healthy Inc

  • High-Volume Logistics: Metronidazole is often ordered in massive quantities for national health programs. We specialize in FCL (Full Container Load) shipments with optimized carton sizes to reduce freight costs per tablet.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >85% of the drug releases within 30 minutes.

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

• Impurities: We strictly monitor for the 2-methyl-5-nitroimidazole impurity to ensure safety.

5. Why Use Metronidazole?

It targets organisms that survive without oxygen.

• Mechanism: It enters the bacterial or protozoal cell. Inside the cell, the nitro group is chemically reduced, creating toxic free radicals. These radicals disrupt the organism’s DNA, causing strand breakage and cell death.

• Key Indications:

  • Anaerobic Bacteria: Dental infections, abdominal abscesses, surgical wound infections.

  • Protozoa: Amebiasis (amoebic dysentery), Giardiasis, Trichomoniasis (STI).

  • H. pylori: Part of the combination therapy to treat stomach ulcers.

  • Vaginosis: Bacterial Vaginosis (BV).

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 Metronidazole Tablets?

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

• Q: Can I drink alcohol while taking it?

  A: ABSOLUTELY NOT. You must avoid alcohol during treatment and for 48 hours after. Combining them causes a “Disulfiram-like Reaction”: severe vomiting, flushing, racing heart, and headache.

• Q: Why is my urine dark?

  A: This is a harmless side effect. Metronidazole metabolites are reddish-brown and can darken the urine. It clears up after stopping the drug.

• Q: Does it leave a bad taste?

  A: Yes. A “metallic taste” in the mouth is a very common side effect. Chewing gum or sucking on hard candy can help.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Anaerobic Infections: 400mg to 500mg every 8 hours.

• Amebiasis: 400mg to 800mg three times daily for 5-10 days.

• Trichomoniasis: 2g (single dose) or 400mg twice daily for 7 days.

• Administration: Swallow whole with water. Taking with food helps reduce stomach upset.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, metallic taste, diarrhea.

• Neurological: High doses or long-term use can cause Peripheral Neuropathy (numbness/tingling in hands/feet) or seizures. Stop immediately if these occur.

• Alcohol: Contraindicated. Severe reaction possible.

• Pregnancy: Avoid in the first trimester unless absolutely necessary.

10. Storage Instructions

• Store below 25°C in a dry place.

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