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Buprenorphine hydrochloride

Drug ingredient

CAS 53152-21-9

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

Molecular structure of 53152-21-9
1 HCl
US productionNot reported
Import value, 2024$103M
Top sourceAustralia 31%

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 293911 · basket

These shares come from HS customs code 293911, which covers 13 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries
AU 31%AustraliaGB 27%United KingdomCZ 19%Czech RepublicDE 14%GermanyES 5%Spain
53 FDA-registered drug labelers
A-S Medication Solutions
Accord Healthcare, Inc
Actavis Pharma, Inc.
Advagen Pharma Ltd
Alvogen Inc.
American Health Packaging
Amneal Pharmaceuticals LLC
Arevipharma GmbH
Asclemed USA, Inc.
Aveva Drug Delivery Systems Inc.
AvPAK
BioDelivery Sciences International Inc
Bryant Ranch Prepack
Camber Pharmaceuticals, Inc.
Cambrex Charles City, Inc
Chattem Chemicals, Inc.
Chr. Olesen Synthesis A/S
Clinical Solutions Wholesale, LLC
Direct_Rx
Dr.Reddys Laboratories Inc
Hikma Pharmaceuticals USA Inc.
Hospira, Inc.
INDIVIOR INC.
Indivior UK Limited
INGENUS PHARMACEUTICALS, LLC
Janssen Pharmaceutica NV
Janssen Pharmaceutical Sciences Unlimited Company
LETCO MEDICAL, LLC
Macfarlan Smith Limited
Major Pharmaceuticals
Medisca Inc.
Mylan Pharmaceuticals Inc.
Noramco Coventry LLC
Noramco, LLC
Orexo US, Inc.
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Par Health USA, LLC
Pharma Source Direct, Inc.
Professional Compounding Centers of America
Redpharm Drug
REMEDYREPACK INC.
Rhodes Pharmaceuticals L.P.
Siegfried AG
Siegfried PharmaChemikalien Minden Gmbh
Siegfried USA, LLC
Somerset Therapeutics, LLC
SpecGx LLC
SUN PHARMACEUTICAL INDUSTRIES, INC.
TAPI Czech Industries s.r.o.
Teva Czech Industries s.r.o
Unichem Laboratories Limited, India
Unit Dose Solutions, Inc.
Veranova, L.P.

Why It Matters

Sectors
Health
Downstream Uses

Appears in 12 drug and cosmetic product listings (FDA).

  • •Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
  • •Buprenorphine and Naloxone
  • •buprenorphine hydrochloride
  • •Buprenorphine and Naloxone Sublingual Film
  • •Buprenorphine
  • •Buprenorphine HCl and Naloxone HCl
  • •Buprenorphine HCl
  • •Zubsolv
Show all 12
  • •Suboxone
  • •Buprenorphine Sublingual
  • •Belbuca
  • •Buprenorphine Sublingual C-III
FDA Shortage Status
No FDA shortage records

Chemical Identity

CAS53152-21-9
PubChem CID3033050
DTXSIDDTXSID2048905
FormulaC29H42ClNO4
Mol. Weight504.1 g/mol
SMILESCC(C)(C)C(C)(C1CC23CCC1(C4C25CCN(C3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)O.Cl

Data Sources

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Brief citations

Buprenorphine hydrochloride (CAS 53152-21-9) https://chemicalindependence.com/chemical/53152-21-9/ PubChem: 3033050. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/3033050 FDA National Drug Code directory: CAS 53152-21-9. 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 293911 for CAS 53152-21-9. Reporting year: 2024. https://usatrade.census.gov/