Pyrimethamine Tablets IP – Manufacturer India

1. Product Introduction

Pyrimethamine is an antifolate antiprotozoal medicine used in selected combination regimens for Toxoplasma gondii infection. It has historical antimalarial use, but widespread resistance and changing treatment guidelines limit its role in malaria. The supplied formulation is Pyrimethamine Tablets IP 25 mg, uncoated. Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter; commercial availability and manufacturing credentials should be verified with current documents.

2. Product Specifications

3. Manufacturing Pyrimethamine Tablets

Appropriate manufacturing controls include verification of active pharmaceutical ingredient identity, validated blending and compression, dosage-unit uniformity, and prevention of cross-contamination. Process parameters and facilities must comply with applicable regulatory requirements. Claims about specific equipment, manufacturing site, WHO-GMP certification and production capacity require current documentary verification.

4. Quality Assurance

Quality control should be based on the approved Indian Pharmacopoeia monograph and registered specifications, including identity, assay, content uniformity, dissolution, impurities and microbial limits where applicable. Batch-specific certificates of analysis and validated methods should be reviewed before supply. No numerical test limits or shelf life are assumed without approved data.

5. Mechanism and Therapeutic Uses

Pyrimethamine inhibits parasite dihydrofolate reductase, impairing folate metabolism and nucleic acid synthesis. For toxoplasmosis, it is commonly used with sulfadiazine and leucovorin (folinic acid) under specialist supervision. Alternative combination regimens may be used when appropriate. It is not recommended as standalone therapy for malaria; antimalarial regimens must follow current local resistance patterns and guidelines. Routine traveler malaria prophylaxis with pyrimethamine alone is not appropriate.

6. Export and Regulatory Support

For B2B procurement, buyers may request product specifications, approved labels, batch certificates of analysis, manufacturing authorization, current GMP evidence, stability records and destination-market registration documents. Availability of CTD/ACTD dossiers, COPP, FSC, tenders and shipping terms should be confirmed directly with Healthy Life Pharma Pvt. Ltd. or Healthy Inc.

7. Frequently Asked Questions

Q: What strength and form are supplied? A: The supplied specification lists an uncoated IP 25 mg tablet.

Q: Is pyrimethamine used alone for toxoplasmosis? A: Generally no; specialist regimens typically combine it with another antimicrobial and leucovorin.

Q: Can pyrimethamine alone prevent malaria in travelers? A: No. It is not a suitable routine standalone prophylactic option because of resistance and safety considerations.

Q: Is the sulfadoxine combination available? A: Availability has not been independently confirmed; enquire with the manufacturer.

8. Dosage and Administration

Dosing depends on the indication, patient age and weight, immune status, renal/hepatic function and combination regimen. Toxoplasmosis treatment must be prescribed and monitored by a qualified clinician. Leucovorin is generally co-administered in toxoplasmosis regimens to reduce bone-marrow toxicity. Do not use the historical once-weekly malaria prophylaxis dose as a general recommendation. Never self-prescribe or change a prescribed regimen.

9. Side Effects and Precautions

Important risks include bone-marrow suppression (anemia, leukopenia and thrombocytopenia), nausea, vomiting, rash and hypersensitivity. Severe skin reactions may occur, especially with sulfonamide combinations. Regular blood counts and appropriate folinic acid rescue are important during prolonged therapy. Pyrimethamine is contraindicated in megaloblastic anemia due to folate deficiency. Pregnancy and breastfeeding require specialist risk-benefit assessment, and patients should disclose all other medicines and relevant medical conditions. Seek urgent care for fever, sore throat, unusual bruising, severe rash or breathing difficulty.

10. Storage Instructions

Store according to the temperature, humidity and light-protection requirements on the approved pack label. Keep tablets in original packaging, away from children. Confirm expiry and shelf life from validated stability data; do not assume a universal 36-month period.