Pyrazinamide Tablets/ – Manufacturer India

1. Product Introduction

Pyrazinamide is an antimycobacterial medicine used as part of combination regimens for drug-susceptible tuberculosis. The supplied portfolio includes Pyrazinamide IP 500 mg and 750 mg coated tablets and Pyrazinamide BP 400 mg film-coated tablets. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product description. Product availability and current approvals should be confirmed before procurement.

2. Product Specifications

3. Manufacturing Pyrazinamide Tablets

Appropriate production controls include raw-material identity, validated mixing, tablet compression, coating, process monitoring and prevention of cross-contamination. Specific equipment, production capacity, WHO-GMP status and plant location require documentary confirmation. Coating types must match each approved formulation.

4. Quality Assurance

Batch release testing should follow the applicable approved IP or BP specifications, including identification, assay, dosage-unit uniformity, dissolution, impurities and physical integrity where required. Numerical acceptance limits and shelf life depend on the registered product and should not be assumed.

5. Mechanism and Therapeutic Uses

Pyrazinamide is a first-line antituberculosis medicine used in multidrug regimens, particularly during the intensive phase of treatment for susceptible tuberculosis. It is converted to pyrazinoic acid and has activity against Mycobacterium tuberculosis in certain acidic environments. It must not be used alone to treat active TB because resistance can develop. Pulmonary and some extrapulmonary TB regimens may include it according to local and international guidelines.

6. Export and Regulatory Support

For B2B supply and tenders, request approved product specifications, manufacturing authorization, valid GMP certificates, certificates of analysis, stability records, registration dossiers where available, and destination-country import requirements. Availability of CTD/ACTD, COPP, FSC and FOB/CIF terms must be verified with the supplier.

7. Frequently Asked Questions

Q: Which strengths are listed? A: IP 500 mg and 750 mg coated tablets and BP 400 mg film-coated tablets.

Q: Can pyrazinamide treat TB alone? A: No. It is used with other appropriate TB medicines.

Q: Is it suitable for public health tenders? A: Tender eligibility, registrations, batch documentation and supply capacity must be confirmed with the manufacturer/exporter.

8. Dosage and Administration

Pyrazinamide is prescribed as part of a combination TB regimen. The dose is determined by body weight, treatment schedule, kidney function, other medicines and the applicable national TB guideline. Do not use a universal dose or change treatment without a TB clinician. Complete the prescribed regimen to reduce treatment failure and drug resistance.

9. Side Effects and Precautions

Important risks include liver injury (hepatotoxicity), nausea, loss of appetite, joint pain and elevated uric acid; acute gout can occur. Clinicians should assess liver disease, gout history, renal impairment and interacting medicines and arrange appropriate monitoring. Seek urgent medical care for jaundice, dark urine, persistent vomiting or severe weakness. Pyrazinamide is generally contraindicated in severe hepatic damage and acute gout. Alcohol can increase liver risk.

10. Storage Instructions

Follow the storage conditions and expiry date printed on the approved product label. Keep in original packaging, protected from inappropriate moisture and heat, and out of reach of children. A 36-month shelf life or fixed storage temperature should not be claimed without stability data.