nitisinone

Drug ingredient

CAS 104206-65-7

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

US productionNot reported

Import value, 2024$175M

Top sourceIndia 48%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 291479 · basket

These shares come from HS customs code 291479, which covers 95 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries

Country of origin for US imports, from Census customs data (2024).

IN 48%IndiaCN 20%ChinaMX 19%MexicoDE 10%GermanyFI 2%Finland

Ukraine
Japan
Australia
Netherlands
South Korea
Canada
Switzerland
Russia
Poland
Italy
United Kingdom
Spain
Taiwan
Grenada

14 FDA-registered drug labelers

Amino Chemicals Ltd

Analog Pharma

Anthem Biosciences Limited

Bachem AG

Bryant Ranch Prepack

Cohance Lifesciences Limited

Cycle Pharmaceuticals Ltd.

Endo USA, Inc.

Eton Pharmaceuticals, Inc.

NURAY CHEMICALS PRIVATE LIMITED

PENN PHARMACEUTICAL SERVICES LTD

SCL Lifesciences Limited

Sionc Pharmaceutical Private Limited

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Why It Matters

Sectors

Health

Downstream Uses

Appears in 4 drug and cosmetic product listings (FDA).

•Nitisinone
•Nityr
•Orfadin
•Harliku

FDA Shortage Status

Whether any manufacturer currently reports this drug as in shortage on the FDA Drug Shortages database. "Active Shortage" means at least one presentation has status "current."

No FDA shortage records

Chemical Identity

CAS104206-65-7

PubChem CID115355

DTXSIDDTXSID9042673

FormulaC14H10F3NO5

Mol. Weight329.23 g/mol

SMILESC1CC(=O)C(C(=O)C1)C(=O)C2=C(C=C(C=C2)C(F)(F)F)[N+](=O)[O-]

Data Sources

PubChem · compound 115355Retrieved 2026-04-07
FDA National Drug Code directoryRetrieved 2026-04-25
FDA National Drug Code directoryRetrieved 2026-04-07
US Census international tradeReporting year: 2024 · Retrieved 2026-10-04

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Brief citations

nitisinone (CAS 104206-65-7) https://chemicalindependence.com/chemical/104206-65-7/ PubChem: 115355. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/115355 FDA National Drug Code directory: CAS 104206-65-7. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA National Drug Code directory: bulk match. Retrieved 2026-04-07. https://open.fda.gov/data/ndc/ US Census international trade: HS 291479 for CAS 104206-65-7. Reporting year: 2024. https://usatrade.census.gov/