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Tibolone

Drug ingredient

CAS 5630-53-5

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

Molecular structure of 5630-53-5
US productionNot reported
Import value, 2024$76M
Top sourceSpain 35%

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 293723 · basket

These shares come from HS customs code 293723, which covers 29 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries
ES 35%SpainNL 19%NetherlandsCN 18%ChinaIT 16%ItalyHU 4%Hungary
4 FDA-registered drug labelers
Hubei Gedian Humanwell Pharmaceutical Co.,Ltd.
Industriale Chimica s.r.l.
NEWCHEM SPA
SHAKTI LIFESCIENCE PRIVATE LIMITED

Why It Matters

Sectors
Health
Downstream UsesNot recorded
FDA Shortage Status
No FDA shortage records

Chemical Identity

CAS5630-53-5
PubChem CID444008
DTXSIDDTXSID5023667
FormulaC21H28O2
Mol. Weight312.4 g/mol
SMILESCC1CC2=C(CCC(=O)C2)C3C1C4CCC(C4(CC3)C)(C#C)O

Data Sources

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Brief citations

Tibolone (CAS 5630-53-5) https://chemicalindependence.com/chemical/5630-53-5/ PubChem: 444008. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/444008 FDA National Drug Code directory: CAS 5630-53-5. 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 293723 for CAS 5630-53-5. Reporting year: 2024. https://usatrade.census.gov/