Nitisinone
Overview
Nitisinone is an inhibitor of the enzyme 4-Hydroxyphenylpyruvate dioxygenase used in the treatment of hereditary tyrosinemia type 1 (HT-1), a genetic disorder that can cause liver and kidney damage. It prevents the accumulation of toxic byproducts of tyrosine metabolism by blocking its catabolic pathway.
API suppliers (5)
Suppliers of Nitisinone evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 4 of 5 suppliers.
3 of 5 hold a GMP certificate on record in the EU or UK registers
- NOVITIUM PHARMA LLCUnited States1 active DMF
- Scl Lifesciences LimitedIndia1 active DMF GMP on record
- DIPHARMA SASwitzerland1 active DMF GMP on record
- BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
- Zydus Lifesciences LimitedIndia GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (20 approved US products), the latest listed US patent on Nitisinone expires 5 Jan 2035 and exclusivity 10 Jun 2032. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
Do you supply Nitisinone? Get in front of buyers actively sourcing it.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.