Last updated: April 23, 2026
Who Supplies PSEUDOEPHEDRINE HYDROCHLORIDE for Pharmaceutical Use?
Pseudoephedrine hydrochloride (CAS 145-13-1) is supplied by a mix of large global chemical manufacturers and specialty API intermediates providers. The supplier landscape is constrained by regulatory controls on pseudoephedrine (notably restrictions on diversion risk), so sourcing is typically routed through companies that can support controlled-substance compliance, licensing, and end-use documentation.
Who are the major manufacturers and distributors of pseudoephedrine hydrochloride?
Below are established supplier organizations that market or distribute pseudoephedrine hydrochloride as an ingredient or API material for pharmaceutical and chemical use, including typical roles as manufacturer, exporter, or distributor.
| Supplier |
Common role in market |
What they typically supply |
Region/coverage |
| Hefei TNJ Chemical Industry Co., Ltd. |
Manufacturer / supplier |
Pseudoephedrine hydrochloride (CAS 145-13-1) |
China (global sales) |
| TCI Chemicals (Tokyo Chemical Industry) |
Supplier/distributor |
Pseudoephedrine hydrochloride for research and manufacturing channels |
Japan with global distribution |
| Santa Cruz Biotechnology |
Distributor |
Pseudoephedrine hydrochloride (catalog sales) |
U.S.-based global shipping |
| Cayman Chemical |
Distributor |
Pseudoephedrine hydrochloride for research use |
U.S.-based |
| Merck KGaA (Sigma-Aldrich brand) |
Distributor |
Pseudoephedrine hydrochloride (catalog sales) |
Global distribution footprint |
| Mitsubishi Chemical Group / affiliates (industry channel suppliers) |
Supplier channel |
Specialty chemical supply including controlled precursors depending on compliance |
Japan/Asia channel presence |
| BASF supply partners (API/chemical intermediates channels) |
Supplier channel |
Intermediates and regulated chemical supply through compliance programs |
EU/Global channel presence |
| VWR / Fisher Scientific / Thermo channel suppliers |
Distributor |
Catalog distribution of pseudoephedrine hydrochloride where permitted |
Global |
Control note: Pseudoephedrine hydrochloride sits in a heavily monitored supply chain because it can be used in illicit drug manufacture. In many jurisdictions, suppliers must implement customer qualification, transaction monitoring, and documentation to remain compliant with precursor regulations.
What compliance constraints shape supplier eligibility?
Pseudoephedrine is regulated as a “controlled precursor” across multiple jurisdictions. Sourcing often requires:
- Customer identity and end-use declarations (wholesale distribution and manufacturing use).
- Licensing or registration for storage, handling, and distribution where required.
- Transaction and recordkeeping under precursor control laws and regulations.
- Supplier due diligence to mitigate diversion risk.
Regulatory frameworks referenced below:
- United States: Pseudoephedrine and related salts are regulated under the U.S. Chemical Diversion and Trafficking Act and associated implementing rules; reporting, recordkeeping, and registration requirements can apply to handlers and exporters/importers. [1]
- European Union: Pseudoephedrine is treated as a regulated drug precursor under EU rules that control trade, possession, and distribution via licensing and reporting. [2]
- International: Pseudoephedrine is listed in UN drug precursor control frameworks that bind signatory states to control and monitoring. [3]
How to screen pseudoephedrine hydrochloride suppliers for pharma-grade readiness
For pharmaceutical R&D or commercial API sourcing, supplier vetting should prioritize technical and regulatory readiness:
| Screening dimension |
Target evidence to require |
| Quality system |
GMP capability or established quality management; ability to provide CoA and traceability packages |
| Specification transparency |
Defined API specifications (assay, impurities, residual solvents) and analytical methods |
| Documentation package |
Certificate of Analysis (CoA), Specification sheet, and regulatory documents tied to precursor handling |
| Manufacturing consistency |
Batch-to-batch consistency data; defined production routes |
| Controlled-substance/pre-precursor compliance |
Proof of ability to operate under precursor regulations for your jurisdiction |
| Supply chain stability |
Lead time, capacity commitments, and tier-1 supply continuity |
Common product variants and what suppliers typically offer
Suppliers generally align pseudoephedrine hydrochloride availability across these formats:
- API-grade pseudoephedrine hydrochloride (pharmaceutical ingredient channel)
- Research-grade pseudoephedrine hydrochloride (catalog channel)
- Bulk packaging for manufacturing or formulation work, where permitted
Supplier portfolios may split these categories by channel. Catalog distributors often sell for research use under their own compliance constraints, while API manufacturers support pharmaceutical documentation requirements and manufacturing controls.
Practical supplier strategy by use case
| Use case |
Typical supplier path |
Rationale |
| Early R&D (milligram to gram scale) |
Catalog distributors and specialty chemical suppliers |
Faster procurement and less paperwork volume where permitted |
| Process development and method work |
Intermediate manufacturers and API-channel suppliers |
Need for batch traceability and impurity profiling |
| Commercial API procurement |
GMP API manufacturers with precursor compliance capability |
Requires full compliance and consistent supply |
Key regulatory checkpoints suppliers must clear
Pseudoephedrine procurement is not limited to product purity. The operational constraint is the controlled precursor status:
- Registration/licensing for import/export and handling depending on jurisdiction and role in supply chain. [1,2]
- Recordkeeping and reporting for covered transactions. [1,2]
- International controls through UN precursor frameworks that drive national implementation. [3]
Supplier list: high-probability sources by commercial channel
Because pseudoephedrine hydrochloride supply is compliance-gated and can vary by country and time, the most reliable approach is to shortlist suppliers that consistently market the chemical and publish distribution footprints. The following are prominent, widely visible sources of pseudoephedrine hydrochloride in standard chemical catalogs and/or industrial supply channels:
- TCI Chemicals (global chemical distributor) [4]
- Santa Cruz Biotechnology (U.S. distributor) [5]
- Cayman Chemical (U.S. distributor) [6]
- Sigma-Aldrich / Merck KGaA (global catalog distributor) [7]
- Hefei TNJ Chemical Industry Co., Ltd. (bulk chemical supplier) [8]
For commercial pharma supply, these catalog sources may not be sufficient alone. The supplier that can deliver GMP-grade material with full precursor compliance documentation is the differentiator, and firms typically route through API distributors or direct GMP manufacturers once qualification begins.
Key Takeaways
- Pseudoephedrine hydrochloride (CAS 145-13-1) is widely marketed by chemical catalog and industrial chemical suppliers, but actual eligibility for pharma supply is gated by precursor-control compliance.
- Supplier qualification for pharma use centers on GMP readiness, full documentation (CoA/specs), and controlled-precursor operational compliance.
- In the supplier market, TCI, Sigma-Aldrich, Santa Cruz, Cayman, and TNJ Chemical are prominent visible sources; commercial readiness depends on whether they can provide pharma-grade and compliance-complete material for your jurisdiction and intended use.
- Under U.S., EU, and UN precursor control regimes, suppliers must implement registration/licensing, reporting, and recordkeeping for covered handling and trade. [1-3]
FAQs
1) What is pseudoephedrine hydrochloride’s CAS number?
CAS is 145-13-1. [4]
2) Are pseudoephedrine hydrochloride suppliers regulated differently from standard commodity chemicals?
Yes. Pseudoephedrine is controlled as a drug precursor, so supplier eligibility depends on compliance obligations such as licensing, reporting, and recordkeeping. [1-3]
3) Can catalog distributors supply pharma-grade pseudoephedrine hydrochloride?
Some catalog distributors can supply material, but pharma qualification generally requires GMP-grade documentation and precursor compliance aligned to the buyer’s jurisdiction and use.
4) Why does pseudoephedrine sourcing often require end-use documentation?
Because precursor regulations aim to reduce diversion risk, suppliers must verify lawful end use and maintain compliance records. [1-3]
5) What screening criteria best predict reliable supply for commercial API use?
Prioritize GMP capability, batch traceability, analytical transparency (impurities), and documented precursor compliance operations.
References
[1] U.S. Drug Enforcement Administration (DEA). (n.d.). Chemical Diversion and Trafficking Act (CDTA) and precursor chemical regulatory framework. https://www.deadiversion.usdoj.gov/
[2] European Commission. (n.d.). EU rules on drug precursors (licensing, reporting, and control measures). https://eur-lex.europa.eu/
[3] United Nations Office on Drugs and Crime (UNODC). (n.d.). International drug control conventions and schedules for drug precursors. https://www.unodc.org/
[4] TCI Chemicals. (n.d.). Pseudoephedrine hydrochloride (CAS 145-13-1). https://www.tcichemicals.com/
[5] Santa Cruz Biotechnology. (n.d.). Pseudoephedrine hydrochloride product page. https://www.scbt.com/
[6] Cayman Chemical. (n.d.). Pseudoephedrine hydrochloride product page. https://www.caymanchem.com/
[7] Merck KGaA (Sigma-Aldrich). (n.d.). Pseudoephedrine hydrochloride product listing. https://www.sigmaaldrich.com/
[8] Hefei TNJ Chemical Industry Co., Ltd. (n.d.). Pseudoephedrine hydrochloride (CAS 145-13-1). https://www.tnjchem.com/
