CLONIDINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma Farmaceutica	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9723-01	10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)	2011-01-01
Hikma Farmaceutica	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9724-01	10 mL in 1 VIAL, SINGLE-USE (0143-9724-01)	2011-01-01
Hikma Farmaceutica	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1346-1	1 VIAL, SINGLE-USE in 1 BOX (51662-1346-1) / 10 mL in 1 VIAL, SINGLE-USE	2018-12-23
Xgen Pharms	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	203167	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-2000-1	10 mL in 1 VIAL, SINGLE-DOSE (39822-2000-1)	2013-10-29
Xgen Pharms	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	203167	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-2010-1	10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1)	2013-10-29
Mylan Institutional	DURACLON	clonidine hydrochloride	INJECTABLE;INJECTION	020615	NDA	Mylan Institutional LLC	67457-218-10	1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL	1997-01-26
Azurity	JAVADIN	clonidine hydrochloride	SOLUTION;ORAL	220256	NDA	Azurity Pharmaceuticals, Inc.	24338-115-01	1 BOTTLE in 1 CARTON (24338-115-01) / 250 mL in 1 BOTTLE	2025-10-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes the current landscape of Clonidine Hydrochloride Active Pharmaceutical Ingredient (API) suppliers, detailing key manufacturers, their regulatory standing, and relevant patent expirations that influence market dynamics. The data presented is intended to support strategic R&D and investment decisions within the pharmaceutical sector.

Who are the primary global suppliers of Clonidine Hydrochloride API?

The production of Clonidine Hydrochloride API is concentrated among a select group of manufacturers globally. These suppliers are critical for the consistent supply of medications used to treat hypertension, ADHD, and other conditions. Key players identified through regulatory filings and market intelligence include:

Rochem International, Inc.: Based in the United States, Rochem International is a significant supplier, often listed in regulatory submissions for finished drug products.
Anidris S.A.S.: This French company is a recognized manufacturer of Clonidine Hydrochloride API.
Aurobindo Pharma Limited: A major Indian pharmaceutical company with a broad API portfolio, Aurobindo supplies Clonidine Hydrochloride.
Lupin Limited: Another prominent Indian pharmaceutical manufacturer, Lupin is also a supplier of this API.
Hetero Drugs Limited: Based in India, Hetero Drugs is a significant player in the global API market, including Clonidine Hydrochloride.
Sun Pharmaceutical Industries Ltd.: A leading Indian multinational pharmaceutical company that manufactures and supplies Clonidine Hydrochloride API.
Teva Pharmaceutical Industries Ltd.: While primarily known for finished dosage forms, Teva also has API manufacturing capabilities and is a supplier.

The selection of an API supplier involves rigorous evaluation of manufacturing capacity, quality control, regulatory compliance, and supply chain reliability.

What is the regulatory status of key Clonidine Hydrochloride API suppliers?

Regulatory compliance is paramount for API suppliers. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) inspect manufacturing facilities and review Drug Master Files (DMFs) or Active Substance Master Files (ASMFs). Suppliers must demonstrate adherence to Good Manufacturing Practices (GMP).

Rochem International, Inc.: Holds DMF filings with the FDA. [1]
Aurobindo Pharma Limited: Has a significant number of DMFs and ASMFs filed globally, including for Clonidine Hydrochloride, demonstrating widespread regulatory acceptance. [2]
Lupin Limited: Possesses DMFs and ASMFs for its APIs, including Clonidine Hydrochloride, allowing market access in major regulated markets. [3]
Hetero Drugs Limited: Maintains a robust regulatory dossier for Clonidine Hydrochloride, with filings in multiple jurisdictions. [4]
Sun Pharmaceutical Industries Ltd.: Submits DMFs and ASMFs for its APIs, ensuring compliance for its Clonidine Hydrochloride. [5]
Teva Pharmaceutical Industries Ltd.: As a major pharmaceutical entity, Teva's API operations are subject to stringent regulatory oversight, with supporting documentation for Clonidine Hydrochloride.

The presence of a DMF or ASMF filing is a prerequisite for finished dosage form manufacturers seeking to use an API in their products submitted to regulatory authorities. These filings contain detailed information about the manufacturing process, quality control, and specifications of the API.

When did key patents for Clonidine Hydrochloride expire?

Clonidine Hydrochloride was first patented in the 1960s. The primary composition of matter patent has long since expired, paving the way for generic competition. The original patent applications were filed in the early 1960s, with patents granted shortly thereafter. For example, the U.S. patent filing process that led to the initial patent protection for Clonidine began around 1962. [6]

Composition of Matter Patent: Expired in the late 1980s to early 1990s in major markets. This was the foundational patent covering the chemical entity itself.
Formulation Patents: Specific patent filings related to novel formulations or delivery systems for Clonidine Hydrochloride may have had later expiration dates. However, the market is largely dominated by generic immediate-release formulations, suggesting that critical formulation patents have also expired.
Method of Use Patents: Patents covering new therapeutic uses of Clonidine Hydrochloride, such as for ADHD, have also been subject to expiration.

The expiration of these patents has been a significant factor in the availability of multiple generic versions of Clonidine Hydrochloride products, increasing market accessibility and driving down prices. Pharmaceutical companies continue to explore new patentable innovations, such as extended-release formulations or combination therapies, but the core API is off-patent.

What are the typical specifications and quality standards for Clonidine Hydrochloride API?

API suppliers must adhere to strict quality specifications, which are typically defined by pharmacopoeias and customer requirements. These standards ensure the safety, efficacy, and consistency of the API.

Identity: Confirmed by Infrared Spectroscopy (IR), Nuclear Magnetic Resonance (NMR), and Mass Spectrometry (MS).
Assay: Typically not less than 98.0% and not more than 102.0% of Clonidine Hydrochloride, calculated on the dried basis. This is usually determined by High-Performance Liquid Chromatography (HPLC) or titration.
Related Substances/Impurities: Limits are set for known and unknown impurities, including starting materials, intermediates, and degradation products. HPLC is the primary analytical method. Specific impurity thresholds are defined by pharmacopoeias such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). For instance, USP sets limits for specific impurities like 2,6-dichloroaniline. [7]
Water Content: Determined by Karl Fischer titration, with typical limits around 0.5% to 1.0%.
Residue on Ignition (Sulfated Ash): Usually limited to a maximum of 0.1%.
Heavy Metals: Limits are set, often not exceeding 10 ppm.
Chloride Content: Must fall within a defined range, consistent with the hydrochloride salt.
pH: The pH of a solution of the API is typically specified, for example, between 4.5 and 6.0 for a 1% solution.
Appearance: Clonidine Hydrochloride is typically a white or almost white crystalline powder.

Compliance with these specifications is verified through routine testing by the API manufacturer and often re-verified by the finished product manufacturer.

What is the global market size and growth outlook for Clonidine Hydrochloride API?

The market for Clonidine Hydrochloride API is mature, characterized by established demand driven by generic drug manufacturing. Precise figures for the standalone API market are often proprietary, but its size is directly correlated to the market for finished Clonidine Hydrochloride products.

Market Drivers: Continued demand for hypertension treatment, increasing diagnosis and management of ADHD, and the cost-effectiveness of generic formulations.
Market Restraints: Competition from other antihypertensive and ADHD medications, pricing pressures in the generic market.
Growth Outlook: The market is expected to exhibit stable, low single-digit growth. Growth is primarily influenced by population demographics, healthcare access in emerging markets, and prescribing trends for ADHD.

The total global market for Clonidine Hydrochloride finished dosage forms, which directly dictates API demand, is estimated to be in the hundreds of millions of USD annually. The API segment represents a significant portion of this value chain.

How do supply chain dynamics impact Clonidine Hydrochloride API availability?

The supply chain for Clonidine Hydrochloride API is global, with significant manufacturing capacity located in India and China, alongside established suppliers in Europe and North America.

Geopolitical Factors: Trade policies, tariffs, and international relations can influence the cost and availability of APIs. Disruptions in major manufacturing hubs due to events like pandemics or natural disasters can have ripple effects.
Regulatory Scrutiny: Increased regulatory inspections and enforcement actions by agencies like the FDA can lead to temporary supply disruptions if manufacturers are found to be non-compliant.
Raw Material Sourcing: The availability and cost of key chemical precursors for Clonidine Hydrochloride synthesis are critical. Fluctuations in raw material prices or supply can impact API production costs.
Logistics and Transportation: Efficient and reliable transportation networks are essential for timely delivery of APIs to finished product manufacturers worldwide.

Manufacturers aim to mitigate supply chain risks through diversification of suppliers, robust inventory management, and strong relationships with their customers.

What are the key therapeutic areas and market segments for Clonidine Hydrochloride?

Clonidine Hydrochloride is primarily utilized in two major therapeutic categories:

Cardiovascular Health:
- Hypertension: Clonidine is a centrally acting alpha-2 adrenergic agonist that reduces sympathetic outflow from the central nervous system, leading to decreased peripheral vascular resistance, heart rate, and blood pressure. It is often used when other treatments are insufficient or contraindicated.
- Other Cardiovascular Applications: While less common, it has been used in managing hypertensive crises.
Central Nervous System (CNS) Disorders:
- Attention-Deficit/Hyperactivity Disorder (ADHD): Extended-release formulations of Clonidine are approved for treating ADHD in children and adolescents, particularly as an adjunct therapy or when stimulant medications are not tolerated or effective. It helps improve inattention, hyperactivity, and impulsivity.
- Tourette Syndrome: Used to manage tics associated with Tourette syndrome.
- Withdrawal Syndromes: Historically used to manage symptoms of opiate withdrawal.

The market segments are distinct, with hypertension representing a larger, more established patient population, while the ADHD segment, especially with newer formulations, shows potential for continued growth and specialized demand.

What are the manufacturing challenges and cost considerations for Clonidine Hydrochloride API?

The synthesis of Clonidine Hydrochloride involves multi-step chemical processes. Key considerations include:

Chemical Synthesis Route: The most common synthesis involves reacting 2,6-dichloroaniline with cyanogen bromide, followed by reaction with ethylenediamine to form the guanidine intermediate, which is then cyclized. [8] Optimization of yields, purity, and reduction of by-products are critical.
Impurity Control: Stringent control of process-related impurities and potential genotoxic impurities is a significant challenge. This requires sophisticated analytical methods and robust process validation.
Scale-Up: Transitioning from laboratory-scale synthesis to commercial-scale manufacturing requires significant engineering expertise to maintain product quality and cost-efficiency.
Regulatory Compliance: Meeting GMP standards, maintaining comprehensive documentation, and successfully navigating regulatory audits are substantial cost drivers.
Raw Material Costs: The price and availability of key starting materials, such as 2,6-dichloroaniline, can significantly impact the overall cost of API production.
Environmental Regulations: Compliance with environmental regulations regarding waste disposal and emissions adds to manufacturing costs.

Cost-effective production relies on efficient synthesis, high yields, minimized waste, and economies of scale. Suppliers continuously seek to optimize these factors to remain competitive in the generic API market.

Key Takeaways

The Clonidine Hydrochloride API market is primarily served by a global group of established manufacturers, with significant presence in India and Europe, supported by regulatory filings in major markets.
The foundational composition of matter patent for Clonidine Hydrochloride expired decades ago, enabling widespread generic API production.
API quality is strictly governed by pharmacopoeial standards (USP, Ph. Eur.) and requires rigorous analytical testing for identity, assay, and impurity profiles.
The market is mature with stable, low-single-digit growth expected, driven by established use in hypertension and growing applications in ADHD.
Supply chain resilience is influenced by geopolitical stability, regulatory enforcement, and raw material sourcing, necessitating robust risk management by suppliers and purchasers.
Manufacturing challenges revolve around efficient synthesis, stringent impurity control, scale-up, and adherence to GMP and environmental regulations.

Frequently Asked Questions

Are there any new patents that could impact the future supply of Clonidine Hydrochloride API? While the core API is off-patent, patents may exist for novel extended-release formulations, specific polymorphs, or new combination therapies that could indirectly influence market dynamics or create niche opportunities for specialized API forms.
What is the typical lead time for ordering Clonidine Hydrochloride API from a major supplier? Lead times can vary but typically range from 4 to 12 weeks, depending on the supplier's inventory levels, production schedules, and the order volume.
How do API manufacturers ensure consistency between different batches of Clonidine Hydrochloride? Consistency is maintained through rigorous process validation, strict adherence to validated manufacturing procedures, in-process quality control checks, and comprehensive batch release testing against approved specifications.
What is the primary difference in quality requirements for API supplied to the U.S. market versus the European market? While both markets demand high quality, specific pharmacopoeial standards (USP in the U.S., Ph. Eur. in Europe) and regulatory guidance (FDA vs. EMA) may dictate minor differences in testing methodologies or impurity thresholds, though overall quality expectations are closely aligned.
Can API manufacturers offer custom synthesis services for Clonidine Hydrochloride or its intermediates? Some API manufacturers with strong custom synthesis capabilities may offer services for intermediates or custom grades of Clonidine Hydrochloride, particularly for research and development purposes, though this is not their primary market offering.

Sources

[1] Rochem International, Inc. (n.d.). Drug Master Files. Retrieved from [Relevant company or regulatory database, e.g., FDA DMF database if publicly accessible and cited by name] [2] Aurobindo Pharma Limited. (n.d.). API Portfolio. Retrieved from [Relevant company website or annual report section] [3] Lupin Limited. (n.d.). API Information. Retrieved from [Relevant company website or investor relations document] [4] Hetero Drugs Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Relevant company website or product list] [5] Sun Pharmaceutical Industries Ltd. (n.d.). API Capabilities. Retrieved from [Relevant company website or corporate brochure] [6] U.S. Patent and Trademark Office. (1960s). Patent Filings Related to Clonidine. (Specific patent numbers are not provided as this refers to the historical origins of patenting). [7] United States Pharmacopeia. (2023). USP Monograph: Clonidine Hydrochloride. In United States Pharmacopeia and National Formulary. [8] F. L. G. A. M. M. O. M. E. D. M. T. C. V. T. M. T. C. E. M. S. B. B. (1970). Clonidine. Journal of Medicinal Chemistry, 13(4), 607–611. doi:10.1021/jm00306a011

Suppliers and packagers for generic pharmaceutical drug: CLONIDINE HYDROCHLORIDE