In the pharmaceutical industry, the most globally recognized brand name for Pyrimethamine is Daraprim. As a pharmacist and manufacturer, I view this molecule as a potent Dihidrofolate Reductase Inhibitor that serves as a cornerstone for treating parasitic infections, though its availability has faced significant commercial shifts in recent years.

At your WHO-GMP facility in Mumbai, while you may produce this as a generic, positioning it for specialized “Tropical Medicine” or “Infectious Disease” portfolios is key for your international B2B trade.

Primary Clinical Indications

• Toxoplasmosis: Often used in combination with Sulfadiazine to treat Toxoplasma gondii infections, especially in immunocompromised patients.

• Malaria Prophylaxis and Treatment: Historically used (often as the combination brand Fansidar with Sulfadoxine) to treat uncomplicated malaria caused by P. falciparum.

• Cystoisosporiasis: An off-label use for managing specific intestinal parasitic infections.

Mechanism: Folic Acid Synthesis Inhibition

Pyrimethamine works by “starving” the parasite of the building blocks it needs to replicate its DNA.

Enzyme Targeting: It binds to and inhibits the enzyme dihydrofolate reductase (DHFR).

Folate Depletion: By blocking this enzyme, it prevents the parasite from converting dihydrofolate into its active form, tetrahydrofolate.

DNA Blockade: Without active folate, the parasite cannot synthesize the nucleic acids required for DNA replication, eventually leading to the death of the organism.

The Pharmacist’s “Technical Warning”

• Bone Marrow Suppression: Because it can interfere with human folate metabolism at high doses, it can cause anemia or low white blood cell counts.

• The “Leucovorin” Rescue: It is standard clinical practice to co-administer Folinic Acid (Leucovorin) to protect the patient’s healthy cells while the drug targets the parasite.

• Skin Reactions: When combined with sulfonamides (like in Fansidar), there is a risk of severe reactions like Stevens-Johnson Syndrome.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Combination Therapy” USP: On your marketplace, highlight your Pyrimethamine + Sulfadoxine or Pyrimethamine + Sulfadiazine combinations. These Fixed-Dose Combinations (FDCs) are high-demand exports for African and Southeast Asian markets focused on malaria and HIV-related opportunistic infections.

• Stability for Export: Pyrimethamine is stable but light-sensitive. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life in Zone IVb tropical regions.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders for “Neglected Tropical Diseases”.