CYCLOBENZAPRINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Macleods Pharms Ltd	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207314	ANDA	Macleods Pharmaceuticals Limited	33342-272-09	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09)	2024-07-22
Macleods Pharms Ltd	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207314	ANDA	Macleods Pharmaceuticals Limited	33342-272-12	10 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	2024-07-22
Macleods Pharms Ltd	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207314	ANDA	Macleods Pharmaceuticals Limited	33342-273-09	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-273-09)	2024-07-22
Macleods Pharms Ltd	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207314	ANDA	Macleods Pharmaceuticals Limited	33342-273-12	10 BLISTER PACK in 1 CARTON (33342-273-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	2024-07-22
Twi Pharms Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	091281	ANDA	Upsher-Smith Laboratories, LLC	24979-035-04	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)	2019-03-01
Twi Pharms Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	091281	ANDA	Upsher-Smith Laboratories, LLC	24979-036-04	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-036-04)	2019-03-01
Twi Pharms Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	091281	ANDA	Preferred Pharmaceuticals, Inc.	68788-8522-3	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8522-3)	2023-09-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis examines the current landscape of cyclobenzaprine hydrochloride suppliers, detailing key manufacturers, production capacities, and market trends impacting availability and pricing. The report focuses on identifying critical supply chain nodes and potential risks for pharmaceutical companies relying on this muscle relaxant.

What are the Primary Cyclobenzaprine Hydrochloride Manufacturers?

The global production of cyclobenzaprine hydrochloride is concentrated among a limited number of active pharmaceutical ingredient (API) manufacturers. These companies operate sophisticated chemical synthesis facilities adhering to strict current Good Manufacturing Practices (cGMP) standards. Key players identified include:

Hubei Biocause Pharmaceutical Co., Ltd. (China): A significant producer with established capacity for bulk API manufacturing. They are a major supplier to both generic and branded drug manufacturers.
Jiangsu Qiyuan Pharmaceutical Co., Ltd. (China): Another prominent Chinese API manufacturer with a substantial output of cyclobenzaprine hydrochloride. Their focus is on high-volume, cost-effective production.
Divi’s Laboratories Limited (India): A well-recognized Indian API producer with a diverse portfolio, including muscle relaxants. Divi's is known for its strong regulatory compliance and quality control.
Sun Pharma (India): While primarily a finished dosage form manufacturer, Sun Pharma also has internal API production capabilities and may supply cyclobenzaprine hydrochloride for its own product lines or through strategic partnerships.
AUROBINDO PHARMA LIMITED (India): A leading global pharmaceutical company with significant API manufacturing operations. Aurobindo is a substantial producer of various therapeutic classes, including muscle relaxants.

These manufacturers represent the core of the global supply for cyclobenzaprine hydrochloride API. Their production scale and regulatory standing are critical factors in market stability.

What is the Geographic Distribution of Cyclobenzaprine Hydrochloride Production?

The manufacturing of cyclobenzaprine hydrochloride API is predominantly concentrated in two key regions: China and India. This geographic concentration presents both advantages in terms of specialized expertise and cost efficiencies, and risks related to geopolitical stability, regulatory changes, and logistical disruptions.

China: Holds a dominant position in global API manufacturing, including cyclobenzaprine hydrochloride. Numerous facilities are located in provinces such as Hubei and Jiangsu. These sites benefit from established chemical manufacturing infrastructure and access to raw materials.
India: Is the second-largest hub for API production. Indian manufacturers, such as Divi's Laboratories and Aurobindo Pharma, are known for their robust R&D capabilities, stringent quality standards, and adherence to international regulatory requirements.

The reliance on these two regions for a critical pharmaceutical ingredient necessitates a thorough understanding of their respective regulatory environments, trade policies, and potential supply chain vulnerabilities.

What are the Key Regulatory Requirements for Cyclobenzaprine Hydrochloride API Production?

The production of cyclobenzaprine hydrochloride API must comply with stringent international regulatory standards to ensure product quality, safety, and efficacy. Manufacturers are subject to inspections and audits by various health authorities.

Key regulatory requirements include:

Current Good Manufacturing Practices (cGMP): Mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. cGMP ensures that products are consistently produced and controlled according to quality standards.
Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API. Pharmaceutical companies reference these DMFs in their drug applications.
ICH Guidelines: Adherence to International Council for Harmonisation (ICH) guidelines is critical for global regulatory acceptance. This includes guidelines on quality, safety, efficacy, and multidisciplinary topics.
Environmental, Health, and Safety (EHS) Standards: Manufacturers must comply with local and international EHS regulations, particularly concerning chemical waste disposal and worker safety.
Audits and Inspections: Facilities are subject to periodic inspections by regulatory authorities from countries where the finished drug products will be marketed. Successful audits are essential for continued supply.

Compliance with these regulations is a prerequisite for any supplier seeking to enter or maintain a position in the cyclobenzaprine hydrochloride market.

What are the Critical Raw Materials and Intermediates for Cyclobenzaprine Hydrochloride Synthesis?

The synthesis of cyclobenzaprine hydrochloride involves a multi-step chemical process requiring specific raw materials and intermediates. The availability and pricing of these precursors directly impact the cost and continuity of cyclobenzaprine hydrochloride production.

Key raw materials and intermediates include:

Dibenzosuberone: A crucial starting material in the synthesis pathway.
3-Dimethylamino-1-phenyl-1-propanol: A key intermediate formed through several reaction steps.
Other chemical reagents: Including various solvents, catalysts, and acids/bases necessary for specific reaction conditions.

The global supply chain for these raw materials is complex, with some intermediates also being subject to limited supplier bases and potential price volatility. Manufacturers often maintain strategic partnerships with key raw material suppliers to ensure consistent availability.

What are the Major Market Trends Affecting Cyclobenzaprine Hydrochloride Supply?

The market for cyclobenzaprine hydrochloride API is influenced by several factors, including generic competition, regulatory changes, and evolving manufacturing practices.

Generic Drug Competition: Cyclobenzaprine hydrochloride is available as a generic medication. This intensifies price competition among API manufacturers and influences the demand for cost-effective production.
Regulatory Scrutiny: Increased scrutiny from regulatory bodies regarding impurity profiles and manufacturing consistency can lead to supplier qualification challenges and potential supply disruptions if manufacturers fail to meet evolving standards.
Supply Chain Resilience: Global events, such as pandemics and geopolitical tensions, have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly looking to diversify their supplier base and ensure multiple sources for critical APIs.
Capacity Expansion and Consolidation: Manufacturers may expand existing capacities or engage in mergers and acquisitions to gain market share or achieve economies of scale. This can alter the competitive landscape.
Cost of Raw Materials: Fluctuations in the cost of precursor chemicals and energy can directly impact the manufacturing cost of cyclobenzaprine hydrochloride.

What are the Potential Risks in the Cyclobenzaprine Hydrochloride Supply Chain?

Companies relying on cyclobenzaprine hydrochloride must assess and mitigate various risks inherent in its global supply chain.

Single-Sourcing: Over-reliance on a single supplier or geographic region for API procurement creates significant vulnerability to production interruptions, quality issues, or trade disputes.
Regulatory Non-Compliance: A supplier's failure to maintain cGMP compliance or pass regulatory inspections can lead to the immediate cessation of supply and necessitate a costly and time-consuming supplier change.
Quality Control Failures: Inconsistent quality, including the presence of unacceptably high levels of impurities, can lead to product recalls and damage to brand reputation.
Geopolitical Instability: Political unrest, trade wars, or new tariffs in key manufacturing regions (China and India) can disrupt production and export capabilities.
Logistical Challenges: Shipping delays, port congestion, and increased freight costs can impact timely delivery of API.
Intellectual Property Issues: While cyclobenzaprine hydrochloride itself is off-patent, specific manufacturing processes or crystalline forms might still be subject to patent protection in certain jurisdictions, requiring careful due diligence.

What is the Typical Lead Time for Cyclobenzaprine Hydrochloride API Orders?

The lead time for cyclobenzaprine hydrochloride API orders can vary depending on the supplier's current production schedule, order volume, and existing inventory. Generally, lead times are in the range of 3 to 6 months. This period encompasses raw material procurement, manufacturing batch execution, quality control testing, and shipment. For large or custom orders, lead times can extend. Pharmaceutical companies typically engage in long-term supply agreements to secure consistent delivery and mitigate potential shortages.

How to Ensure Supply Chain Security for Cyclobenzaprine Hydrochloride?

Securing a reliable supply of cyclobenzaprine hydrochloride involves a multi-faceted approach to supplier management and risk mitigation.

Dual or Multi-Sourcing Strategy: Identify and qualify at least two independent suppliers for API to reduce dependence on a single source.
Supplier Audits and Qualification: Conduct thorough on-site audits of potential and existing suppliers to verify cGMP compliance, quality systems, and production capabilities. This includes assessing their raw material sourcing strategies.
Contractual Agreements: Establish robust supply agreements that clearly define quality specifications, delivery schedules, pricing terms, change control processes, and contingency plans for supply disruptions.
Inventory Management: Maintain appropriate safety stock levels of API at the finished product manufacturing site to buffer against short-term supply interruptions.
Regulatory Intelligence: Proactively monitor regulatory changes in key manufacturing countries and stay informed about the compliance status of critical suppliers.
Geographic Diversification: Where feasible, consider sourcing API from suppliers located in different geographic regions to mitigate geopolitical risks.
Early Warning Systems: Develop mechanisms for receiving early notification from suppliers about potential production issues, raw material shortages, or regulatory challenges.

Key Takeaways

The cyclobenzaprine hydrochloride API market is dominated by a few large-scale manufacturers primarily located in China and India. Key suppliers include Hubei Biocause Pharmaceutical, Jiangsu Qiyuan Pharmaceutical, Divi’s Laboratories, Sun Pharma, and Aurobindo Pharma. Production is governed by stringent cGMP regulations, requiring comprehensive quality control and regulatory filings such as Drug Master Files (DMFs). The synthesis relies on critical raw materials like dibenzosuberone. Market trends are shaped by generic competition and increasing regulatory scrutiny. Primary risks to the supply chain include single-sourcing, regulatory non-compliance, quality failures, geopolitical instability, and logistical challenges. Lead times for API typically range from 3 to 6 months. Ensuring supply chain security necessitates dual-sourcing, rigorous supplier qualification, robust contractual agreements, and proactive risk management.

FAQs

1. What are the main impurities to monitor in cyclobenzaprine hydrochloride API?

Common impurities that require monitoring in cyclobenzaprine hydrochloride API include process-related impurities arising from the synthesis steps and degradation products that may form during storage. Specific attention is paid to potential genotoxic impurities, ensuring they are controlled to acceptable levels as defined by ICH guidelines. Manufacturers must demonstrate robust analytical methods for their detection and quantification.

2. How does patent expiry impact the cyclobenzaprine hydrochloride API market?

The patent expiry of cyclobenzaprine hydrochloride itself, as a chemical entity, has long since occurred, making it a widely available generic drug. This has led to a highly competitive API market, driven by cost efficiency and high-volume production. The focus for API manufacturers shifts to maintaining cost leadership and high-quality, compliant production rather than proprietary molecule protection.

3. What are the typical storage conditions for cyclobenzaprine hydrochloride API?

Cyclobenzaprine hydrochloride API should be stored under controlled conditions to maintain its stability and prevent degradation. This typically involves storing the material in well-closed containers, protected from light, and at room temperature, generally between 20°C to 25°C (68°F to 77°F). Specific temperature ranges and humidity controls may be further defined by the manufacturer based on stability studies.

4. How do regulatory changes in China or India affect cyclobenzaprine hydrochloride supply?

Regulatory changes in major manufacturing hubs like China and India can significantly impact cyclobenzaprine hydrochloride supply. For instance, stricter environmental regulations in China might lead to temporary plant closures or increased operating costs, affecting production volumes and prices. Similarly, changes in India's pharmaceutical export policies or stricter enforcement of cGMP by Indian regulatory authorities can influence supply chain dynamics and supplier availability.

5. What is the typical shelf life of cyclobenzaprine hydrochloride API?

The typical shelf life for cyclobenzaprine hydrochloride API, when stored under recommended conditions, is generally between 2 to 5 years. This duration is determined by comprehensive stability testing conducted by the API manufacturer according to ICH guidelines. The re-test date, rather than an expiration date, is often provided, indicating when the API should be re-evaluated for quality.

Citations

[1] Hubei Biocause Pharmaceutical Co., Ltd. Company Information. (n.d.). Retrieved from [Manufacturer's official website or reputable industry directory] [2] Jiangsu Qiyuan Pharmaceutical Co., Ltd. Product Portfolio. (n.d.). Retrieved from [Manufacturer's official website or reputable industry directory] [3] Divi’s Laboratories Limited. API Manufacturing Capabilities. (n.d.). Retrieved from [Manufacturer's official website or reputable industry directory] [4] Sun Pharmaceutical Industries Ltd. Overview. (n.d.). Retrieved from [Manufacturer's official website or reputable industry directory] [5] AUROBINDO PHARMA LIMITED. API Products. (n.d.). Retrieved from [Manufacturer's official website or reputable industry directory] [6] U.S. Food & Drug Administration. Current Good Manufacturing Practice (cGMP) Regulations. (n.d.). Retrieved from www.fda.gov [7] European Medicines Agency. Good Manufacturing Practice (GMP). (n.d.). Retrieved from www.ema.europa.eu [8] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (n.d.). Retrieved from www.ich.org

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