In the pharmaceutical industry, Pyrazinamide is a critical first-line antitubercular agent. As a pharmacist and manufacturer, I view this molecule as a “Sterilizing Agent”—it is technically unique because it is the only first-line drug that effectively kills semi-dormant Mycobacterium tuberculosis persisting in acidic environments (like within macrophages), which is essential for shortening the duration of TB treatment.
At your WHO-GMP facility in Mumbai, Pyrazinamide is a high-volume “Essential Medicine” SKU, often produced as standalone tablets (500 mg, 750 mg, 1000 mg) or as part of 3-FDC and 4-FDC (Fixed-Dose Combination) anti-TB regimens.
Therapeutic Profile: Global Brand Names
Pyrazinamide is widely available as a generic, but it is recognized globally and in India under several major trade names:
| Type | Name(s) | Technical Context |
| Global Brands | Tebrazid, Zinamide | Widely recognized in international markets; Zinamide is a common historical brand. |
| Major Indian Brands | Pyzina, P Zide, Macrozide | Manufactured by Lupin, Cadila, and Macleods respectively—all major players in TB care. |
| Combination Brands | Rifater, Akurit-Z, Forecox | FDCs containing Rifampicin, Isoniazid, and Pyrazinamide (± Ethambutol). |
| Other Regional Brands | Pza Ciba, Pyra, Pyromed | Trade names used by Novartis India and various export-oriented manufacturers. |
Mechanism: Intracellular Sterilization
[Image showing Pyrazinamide entering a macrophage and being converted to Pyrazinoic acid to kill dormant TB bacteria]
Pyrazinamide works through a “Prodrug” activation mechanism:
Prodrug Entry: The drug enters the mycobacterial cell and is converted into its active form, Pyrazinoic acid, by the bacterial enzyme pyrazinamidase.
Acidic Environment: It is most active in an acidic pH. This allows it to target bacteria hiding inside “acidic pockets” (phagosomes) of the immune system’s cells.
Metabolic Disruption: It disrupts the bacterial cell membrane potential and inhibits fatty acid synthesis, effectively killing the “persister” bacteria that other drugs cannot reach.
The Pharmacist’s “Technical Warning”
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The “Hepatotoxicity” Profile: As a pharmacist, I must emphasize that Pyrazinamide is the most hepatotoxic of the first-line TB drugs. Regular Liver Function Tests (LFTs) are mandatory throughout the 2-month intensive phase.
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The “Gout” Interaction: It inhibits the renal excretion of uric acid, frequently leading to Hyperuricemia. Patients often experience joint pain (arthralgia); true clinical gout is less common but requires immediate medical attention.
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Photosensitivity: Patients should be warned about increased sensitivity to sunlight. Advise the use of protective clothing and sunscreen during treatment.
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Diabetes Interference: Technically, Pyrazinamide can interfere with ACETEST® (urine ketone tests), potentially giving false-positive results for patients monitoring ketoacidosis.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “FDC Versatility” USP: On your digital marketplace, highlight your expertise in Fixed-Dose Combinations (FDCs). Multi-drug resistance (MDR-TB) prevention relies on patient compliance, which is significantly higher with your 3-in-1 or 4-in-1 tablets.
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Stability for Export: Pyrazinamide is relatively stable but must be protected from light and moisture. Utilizing Alu-Alu blister packaging is the global benchmark for ensuring a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers for Pyrazinamide strengths to support your firm’s registration in international government tenders and NGO procurement programs (UNICEF/Global Fund).