TRIENTINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	SYPRINE	trientine hydrochloride	CAPSULE;ORAL	019194	NDA	Bausch Health US LLC	0187-2120-10	1 BOTTLE in 1 CARTON (0187-2120-10) / 100 CAPSULE in 1 BOTTLE	1985-11-08
Dr Reddys	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211076	ANDA	Dr.Reddys Laboratories Inc	43598-459-01	100 CAPSULE in 1 BOTTLE (43598-459-01)	2019-07-03
Hetero Labs Ltd Iii	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	216356	ANDA	Camber Pharmaceuticals, Inc.	31722-683-01	1 BOTTLE in 1 CARTON (31722-683-01) / 100 CAPSULE in 1 BOTTLE	2022-06-23
Msn	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211134	ANDA	Novadoz Pharmaceuticals LLC	72205-008-91	1 BOTTLE in 1 CARTON (72205-008-91) / 100 CAPSULE in 1 BOTTLE	2019-05-22
Navinta Llc	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211251	ANDA	Navinta LLC	68475-200-01	1 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLE	2020-12-05
Ph Health	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	210096	ANDA	Endo USA, Inc.	49884-060-01	100 CAPSULE in 1 BOTTLE (49884-060-01)	2019-09-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis outlines the current supplier landscape for Trientine Hydrochloride, a critical chelating agent used in treating Wilson's disease. The report identifies key manufacturers, their production capacities, regulatory approvals, and market presence.

Who are the primary manufacturers of Trientine Hydrochloride?

The global supply of Trientine Hydrochloride is concentrated among a limited number of manufacturers. These companies possess the specialized chemistry and regulatory compliance necessary for pharmaceutical-grade production.

Sigma-Aldrich (Merck KGaA): A well-established chemical supplier offering Trientine Hydrochloride in various grades. Its parent company, Merck KGaA, has extensive global operations and a robust supply chain.
Bachem AG: A Swiss company specializing in peptide and oligonucleotide synthesis, Bachem also manufactures complex organic molecules, including Trientine Hydrochloride.
Teva Pharmaceutical Industries Ltd.: A major generic pharmaceutical manufacturer, Teva produces Trientine Hydrochloride as an active pharmaceutical ingredient (API) for its own formulations and potentially for sale to other drug makers.
Sun Pharmaceutical Industries Ltd. : Another significant global pharmaceutical company with API manufacturing capabilities, Sun Pharma is a potential supplier of Trientine Hydrochloride.
Local and Regional Manufacturers: Beyond the major global players, smaller, region-specific API manufacturers may also produce Trientine Hydrochloride, often catering to local markets or specific contract manufacturing needs.

What is the current global production capacity for Trientine Hydrochloride?

Specific, up-to-date production capacity figures for Trientine Hydrochloride are proprietary and not publicly disclosed by most manufacturers. However, market intelligence suggests that current global capacity is sufficient to meet existing demand, with potential for expansion if market needs increase. The complexity of its synthesis and the stringent quality control required limit the number of large-scale producers. The primary drivers for capacity are established demand from Wilson's disease treatment and potential niche applications.

Table 1: Estimated Global Production Capacity Landscape (Qualitative)

Manufacturer Category	Estimated Capacity Contribution	Notes
Major Global API Manufacturers	High	Companies with large-scale, multi-product API facilities, often with US FDA and EMA approvals.
Specialized Chemical Suppliers	Moderate	Companies focusing on niche or complex organic synthesis, may have dedicated or flexible production lines.
Regional Pharmaceutical Players	Low to Moderate	Primarily serve domestic markets, capacity may be scaled for local demand and regulatory environments.

Which regulatory bodies oversee Trientine Hydrochloride production and supply?

Trientne Hydrochloride intended for pharmaceutical use must comply with the regulations of the markets in which it is sold. Key regulatory bodies include:

U.S. Food and Drug Administration (FDA): Approves APIs for use in drugs marketed in the United States. Manufacturers must adhere to Current Good Manufacturing Practices (cGMP).
European Medicines Agency (EMA): Oversees drug approvals and API standards in the European Union. Compliance with EU GMP is mandatory.
Pharmaceuticals and Medical Devices Agency (PMDA) of Japan: Regulates pharmaceutical products and APIs in Japan.
Other National Regulatory Authorities: Countries like Canada, Australia, and numerous others have their own specific agencies and requirements for API sourcing and quality.

What are the key quality and purity standards for pharmaceutical-grade Trientine Hydrochloride?

Pharmaceutical-grade Trientine Hydrochloride must meet rigorous specifications to ensure patient safety and efficacy.

Purity: Typically required to be at least 98.0% or higher, as determined by methods such as High-Performance Liquid Chromatography (HPLC).
Impurities: Strict limits are placed on specified impurities, including related substances, residual solvents, and heavy metals. The European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) set monographs detailing these requirements.
Assay: The active content of Trientine Hydrochloride must fall within a defined range, often 98.0% to 102.0% of the labeled amount.
Identification: Specific tests, such as infrared spectroscopy (IR) and chemical tests, are used to confirm the identity of the compound.
Water Content: Limits are set for the maximum allowable water content, typically determined by Karl Fischer titration.
Heavy Metals: The absence or presence below specified limits of heavy metals is critical.

What is the typical lead time for sourcing Trientine Hydrochloride from manufacturers?

Lead times for Trientine Hydrochloride can vary significantly based on the manufacturer, order volume, and current inventory levels.

Standard Orders: For established customers with regular orders, lead times can range from 4 to 8 weeks.
New or Large Orders: Larger, non-routine orders, or those from new suppliers, may require 8 to 16 weeks or longer, accounting for production scheduling and potential batch manufacturing.
Emergency Needs: Expedited orders are possible but often incur significant premium costs and depend entirely on the manufacturer's immediate production availability.

What factors influence the pricing of Trientine Hydrochloride?

The price of Trientine Hydrochloride is influenced by several factors:

Raw Material Costs: The cost and availability of precursor chemicals are primary drivers.
Manufacturing Complexity: The multi-step synthesis process requires specialized equipment and expertise, contributing to cost.
Regulatory Compliance: Adherence to cGMP standards, including extensive testing and documentation, adds to production expenses.
Order Volume: Larger order quantities typically result in lower per-unit pricing due to economies of scale.
Purity and Grade: Higher purity grades and those meeting specific pharmacopoeial standards command premium pricing.
Supplier Location and Logistics: Geographic location, shipping costs, and import/export duties can impact the final price.

How does the patent landscape affect the availability of Trientine Hydrochloride?

The original patents covering the synthesis and use of Trientine Hydrochloride have long expired. This has facilitated the entry of generic manufacturers and API suppliers. The lack of active, composition-of-matter patents for Trientine Hydrochloride itself means that market access for API producers is primarily governed by their ability to meet regulatory requirements and quality standards for generic drug manufacturing. Any new patents would likely pertain to novel formulations, specific delivery methods, or new therapeutic indications, rather than the molecule itself.

What are the primary applications of Trientine Hydrochloride?

The principal therapeutic use of Trientine Hydrochloride is as a chelating agent for the treatment of Wilson's disease. This is a rare genetic disorder that causes copper to accumulate in the body, leading to severe liver and neurological damage. Trientine binds to excess copper in the body, forming a stable complex that is then excreted, thereby reducing copper levels.

What are the supply chain risks associated with Trientine Hydrochloride?

Potential supply chain risks for Trientine Hydrochloride include:

Limited Supplier Base: A small number of manufacturers can lead to supply vulnerability if one or more cease production or experience disruptions.
Regulatory Changes: Evolving cGMP requirements or new pharmacopoeial standards can necessitate costly process adjustments for manufacturers.
Geopolitical Instability: Disruptions in regions where key raw materials are sourced or where manufacturing facilities are located can impact supply.
Raw Material Shortages: Dependence on specific precursor chemicals means that shortages of these materials can halt Trientine Hydrochloride production.
Quality Control Failures: A single batch failure requiring recall or re-processing can create significant supply gaps.

Key Takeaways

The global supply of pharmaceutical-grade Trientine Hydrochloride is maintained by a concentrated group of established API manufacturers and chemical suppliers. Production capacity is assessed as adequate for current demand, driven primarily by its use in Wilson's disease treatment. Key regulatory bodies, including the FDA and EMA, enforce stringent cGMP and pharmacopoeial standards, which significantly influence manufacturing processes and costs. The absence of active composition-of-matter patents allows for generic competition, with market entry contingent on meeting quality and regulatory hurdles. Potential supply chain risks stem from the limited number of producers, regulatory shifts, and raw material availability.

Frequently Asked Questions

Are there any active patents on Trientine Hydrochloride itself that could restrict its production? No, the primary patents for Trientine Hydrochloride, covering its composition and basic synthesis, have expired. Current patent activity would likely focus on novel formulations or specific therapeutic uses.
Can I source Trientine Hydrochloride for research purposes from chemical suppliers not holding pharmaceutical GMP certifications? While research-grade Trientine Hydrochloride may be available from non-GMP suppliers, it is unsuitable for human use. Pharmaceutical applications require API manufactured under strict cGMP conditions with full regulatory compliance.
What are the implications of a single Trientine Hydrochloride manufacturer experiencing production issues? Given the limited supplier base, a significant disruption at a major manufacturer could lead to temporary shortages, longer lead times, and increased pricing due to elevated demand on remaining suppliers.
How frequently are pharmacopoeial monographs for Trientine Hydrochloride updated? Pharmacopoeial monographs are typically reviewed and updated periodically, often on an annual or biennial basis, by organizations like the USP and Ph. Eur. to reflect current scientific understanding and analytical capabilities.
What is the shelf life of Trientine Hydrochloride API? The shelf life of Trientine Hydrochloride API is determined by the manufacturer based on stability studies conducted under specified storage conditions. It typically ranges from 2 to 5 years, with specific expiry dates indicated on the product packaging.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry on Drug Master Files. [2] European Medicines Agency. (n.d.). Active substances. [3] United States Pharmacopeial Convention. (n.d.). Pharmacopeial Forum. [4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). EDQM Home. [5] Bachem. (n.d.). Product Portfolio. Retrieved from https://bachem.com/ [6] Sigma-Aldrich. (n.d.). Trientine Hydrochloride Product Information. Retrieved from https://www.sigmaaldrich.com/ [7] Teva Pharmaceutical Industries Ltd. (n.d.). API Products. Retrieved from https://www.tevapharm.com/ [8] Sun Pharmaceutical Industries Ltd. (n.d.). API Business. Retrieved from https://www.sunpharma.com/

Suppliers and packagers for generic pharmaceutical drug: TRIENTINE HYDROCHLORIDE