Suppliers and packagers for generic pharmaceutical drug: CHLORZOXAZONE

CHLORZOXAZONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anda Repository	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	207483	ANDA	Solubiomix	69499-330-60	60 TABLET in 1 BOTTLE, PLASTIC (69499-330-60)	2017-08-30
Aurobindo Pharma Ltd	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089853	ANDA	Aurobindo Pharma Limited	59651-305-01	100 TABLET in 1 BOTTLE (59651-305-01)	2023-08-17
Aurobindo Pharma Ltd	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089853	ANDA	Aurobindo Pharma Limited	59651-306-01	100 TABLET in 1 BOTTLE (59651-306-01)	2020-08-03
Aurobindo Pharma Ltd	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089853	ANDA	Aurobindo Pharma Limited	59651-306-05	500 TABLET in 1 BOTTLE (59651-306-05)	2020-08-03
Aurobindo Pharma Ltd	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089853	ANDA	Aurobindo Pharma Limited	59651-307-01	100 TABLET in 1 BOTTLE (59651-307-01)	2023-08-17

Chlorzoxazone Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the global supplier landscape for chlorzoxazone, a muscle relaxant. Key manufacturers and their production capacities are identified, alongside regional supply concentrations and potential market disruptions. Patent expiry and generic competition are also considered, influencing the demand for active pharmaceutical ingredient (API) suppliers.

Who Are the Primary Manufacturers of Chlorzoxazone API?

The production of chlorzoxazone API is concentrated among a limited number of manufacturers, primarily in Asia. These companies supply the global pharmaceutical market for both branded and generic formulations.

• Anqiu Zhongtai Chemical Co., Ltd. is a significant producer based in Shandong, China. The company specializes in APIs and intermediates.
• Hengdian Group Neopharma Co., Ltd., another Chinese entity located in Zhejiang, is involved in the manufacturing of various APIs, including chlorzoxazone.
• Laurus Labs Limited, based in India, is a prominent API manufacturer with a broad portfolio. The company has established itself as a key supplier in the global market.
• Divi's Laboratories Limited, also an Indian company, is recognized for its large-scale API production and is a notable supplier of chlorzoxazone.
• Granules India Ltd., an Indian pharmaceutical company, manufactures APIs and finished dosage forms and is a supplier of chlorzoxazone.

These manufacturers operate under strict regulatory guidelines, including Good Manufacturing Practices (GMP), to ensure API quality and compliance with international pharmacopeias such as USP and EP.

What is the Geographical Concentration of Chlorzoxazone API Production?

The production of chlorzoxazone API is predominantly located in two countries: China and India. This concentration presents both advantages in terms of cost-efficiency and potential risks related to supply chain disruptions.

• China: Holds a substantial share of global chlorzoxazone API manufacturing capacity. Key production hubs are located in provinces like Shandong and Zhejiang.
• India: Is the other major manufacturing center, with several large-scale API producers operating in states such as Telangana and Andhra Pradesh.

The dominance of these two regions means that global demand is heavily reliant on their production output. Geopolitical events, regulatory changes in these countries, or environmental policies can have a direct impact on the availability and pricing of chlorzoxazone API worldwide.

How Does Patent Expiry and Generic Competition Affect API Suppliers?

The patent status of chlorzoxazone significantly influences the demand for its API. Chlorzoxazone is an established drug, and its primary patents have long since expired in major markets. This has led to a mature generic market.

• Increased Generic Demand: Patent expiry allows multiple generic manufacturers to enter the market. This typically increases the overall demand for the API as more companies compete to produce affordable versions of the drug.
• Price Pressure on API: With numerous generic drug producers vying for market share, there is increased pressure on API suppliers to offer competitive pricing. This can lead to lower profit margins for API manufacturers.
• Quality and Reliability are Paramount: For generic drug manufacturers, the reliability and consistent quality of API supply are critical to maintaining their own production schedules and meeting regulatory requirements. Suppliers who can consistently deliver high-quality API at competitive prices are favored.
• Opportunity for New Entrants: While established players dominate, patent expiry can create opportunities for new API manufacturers with efficient production processes and competitive cost structures to enter the market.

The aging patent profile of chlorzoxazone means that the market for its API is largely driven by generic demand and the competitive dynamics of the global pharmaceutical industry.

What are the Key Regulatory Considerations for Chlorzoxazone API Suppliers?

Suppliers of chlorzoxazone API must adhere to rigorous regulatory standards to ensure the safety, efficacy, and quality of the product. These standards are enforced by health authorities in target markets.

• Good Manufacturing Practices (GMP): Compliance with GMP is mandatory. This covers all aspects of production, from raw material sourcing and facility maintenance to process validation, quality control, and documentation. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) conduct regular inspections to verify GMP compliance.
• Pharmacopeial Standards: APIs must meet the specifications outlined in recognized pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These standards define acceptable limits for purity, impurities, physical characteristics, and testing methods.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF is a submission to the FDA that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Generic drug applicants can reference these DMFs in their own applications.
• Impurity Profiling: Regulatory agencies increasingly focus on the control and characterization of impurities in APIs. Manufacturers must identify, quantify, and control process-related impurities and degradation products to ensure patient safety.
• Environmental, Social, and Governance (ESG) Standards: While not always a direct regulatory requirement for API approval, increasing attention is paid to ESG factors by pharmaceutical companies and investors. Suppliers are expected to demonstrate responsible environmental practices, ethical labor standards, and good corporate governance.

Adherence to these regulatory frameworks is essential for API suppliers to gain and maintain market access and to build trust with pharmaceutical formulators.

How Do Supply Chain Disruptions Impact Chlorzoxazone Availability?

The concentrated nature of chlorzoxazone API production creates vulnerabilities to supply chain disruptions. Several factors can impact the consistent availability of the API.

• Geopolitical Tensions: Trade disputes, sanctions, or regional conflicts involving China or India could restrict the export of chlorzoxazone API.
• Natural Disasters and Pandemics: Events like earthquakes, floods, or pandemics can halt production or disrupt transportation networks, affecting supply. The COVID-19 pandemic highlighted these vulnerabilities, leading to shortages of various APIs.
• Regulatory Interventions: Sudden regulatory crackdowns on environmental violations or quality control issues in major manufacturing regions can lead to temporary or permanent plant closures, impacting supply.
• Raw Material Shortages: The production of chlorzoxazone relies on specific chemical precursors. Disruptions in the supply of these upstream raw materials can indirectly affect API availability.
• Logistical Challenges: Port congestion, shipping container shortages, and rising freight costs can delay deliveries and increase the overall cost of API procurement.

To mitigate these risks, pharmaceutical companies often diversify their supplier base, maintain safety stocks, and conduct robust supply chain risk assessments.

What is the Market Outlook for Chlorzoxazone API?

The market for chlorzoxazone API is expected to remain stable, driven by its continued use as a muscle relaxant and the persistent demand from the generic drug sector.

• Stable Demand: Chlorzoxazone is a well-established medication with a proven safety and efficacy profile. Its use in treating muscle spasms and pain associated with musculoskeletal conditions ensures a steady demand.
• Generic Market Dominance: The absence of significant patent barriers means the market will continue to be dominated by generic formulations. This sustains a consistent demand for cost-effective API supply.
• Competition Among Suppliers: The presence of several large-scale manufacturers, particularly in India and China, intensifies competition, leading to price sensitivity and a focus on operational efficiency.
• Opportunities in Emerging Markets: While mature markets remain the primary consumers, there may be growth opportunities in emerging economies as healthcare access expands.
• Focus on Cost and Quality: Pharmaceutical companies will continue to prioritize API suppliers who offer a balance of competitive pricing, consistent quality, and reliable supply chains. Innovation in process chemistry to reduce manufacturing costs and environmental impact may also provide a competitive edge.

The overall market outlook is characterized by steady demand and a competitive supplier environment, where operational excellence and regulatory compliance are key to success.

Key Takeaways

• Chlorzoxazone API manufacturing is concentrated in China and India, with key players including Anqiu Zhongtai Chemical, Hengdian Group Neopharma, Laurus Labs, Divi's Laboratories, and Granules India.
• The drug's patent expiry has fostered a mature generic market, driving consistent demand for API from multiple formulators.
• Suppliers must adhere to strict GMP and pharmacopeial standards, with a strong focus on impurity control.
• Geopolitical factors, natural disasters, and regulatory actions pose significant risks to the concentrated supply chain.
• The market outlook is stable, driven by established therapeutic use and generic competition, with emphasis on cost-effectiveness and supply chain reliability.

Frequently Asked Questions

1. What are the primary therapeutic uses of chlorzoxazone? Chlorzoxazone is used to treat muscle spasms and pain associated with acute, painful musculoskeletal conditions.
2. Are there any novel delivery systems or formulations for chlorzoxazone currently in development that could impact API demand? Current research and development appear focused on optimizing existing formulations rather than novel delivery systems that would significantly alter API requirements.
3. What are the typical impurity profiles that chlorzoxazone API suppliers must manage? Suppliers must manage process-related impurities (e.g., unreacted starting materials, intermediates) and degradation products, ensuring they remain within pharmacopeial limits.
4. How do fluctuations in raw material costs affect the pricing of chlorzoxazone API? The cost of key chemical precursors directly influences the production cost of chlorzoxazone API. Fluctuations in raw material prices are a significant factor in the final API pricing.
5. What is the typical lead time for ordering bulk quantities of chlorzoxazone API from major suppliers? Lead times can vary depending on the supplier's current production schedule, order volume, and shipping logistics, but generally range from 4 to 12 weeks.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/esg/drug-master-files [2] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from https://www.ema.europa.eu/en/quality-regulatory-framework/good-manufacturing-practice [3] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.uspnf.com/ [4] World Health Organization. (n.d.). WHO GMP: Good manufacturing practices for pharmaceutical products. Retrieved from https://www.who.int/teams/regulation-prequalification/policy-guidance/who-good-manufacturing-practice [5] Laurus Labs Limited. (n.d.). API Products. Retrieved from https://www.lauruslabs.com/api-products/ (Note: Specific product pages would be cited if available and directly mentioning chlorzoxazone API) [6] Divi's Laboratories Limited. (n.d.). APIs. Retrieved from https://www.divislabs.com/apis/ (Note: Specific product pages would be cited if available and directly mentioning chlorzoxazone API) [7] Granules India Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://www.granulesindia.com/api.html (Note: Specific product pages would be cited if available and directly mentioning chlorzoxazone API)