TIZANIDINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	213223	ANDA	Alembic Pharmaceuticals Limited	46708-491-08	80 BLISTER PACK in 1 CARTON (46708-491-08) / 8 CAPSULE in 1 BLISTER PACK	2020-01-15
Alembic	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	213223	ANDA	Alembic Pharmaceuticals Limited	46708-491-30	30 CAPSULE in 1 BOTTLE (46708-491-30)	2020-01-15
Alembic	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	213223	ANDA	Alembic Pharmaceuticals Limited	46708-491-41	150 CAPSULE in 1 BOTTLE (46708-491-41)	2020-01-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Tizanidine hydrochloride is a centrally acting alpha-2 adrenergic agonist used predominantly as a muscle relaxant for conditions such as multiple sclerosis, spinal cord injury, and other muscle spasticity disorders. Its efficacy in reducing muscle tone and spasticity has led to broad utilization across global markets. Consequently, an extensive supply chain network sustains its manufacturing, distribution, and commercialization.

This article provides an in-depth analysis of the primary suppliers involved in the production of tizanidine hydrochloride, encompassing active pharmaceutical ingredient (API) manufacturers, excipient suppliers, and Finished Dosage Form (FDF) producers. Insight into key players, geographic distribution, and supply chain dynamics equips pharmaceutical stakeholders to make informed decisions regarding sourcing, risk management, and regulatory compliance.

Global API Manufacturers of Tizanidine Hydrochloride

1. Major Active Pharmaceutical Ingredient Producers

The API manufacturing landscape for tizanidine hydrochloride features both branded and generic producers, predominantly situated in Asia, Europe, and North America. Their scale, regulatory standards, and technological capabilities influence supply stability and cost-effectiveness.

a. Chinese Manufacturers

China remains a dominant force in API production, driven by cost advantages and large-scale manufacturing infrastructure. Several Chinese API producers supply tizanidine hydrochloride to global markets, often through contract manufacturers or direct exports:

Hefei Zhongxin Pharmaceutical Co., Ltd.
Specializes in synthesis of central nervous system (CNS) APIs, including tizanidine hydrochloride. Their manufacturing processes comply with GMP standards, targeting both domestic and international clients.
Qingdao BGI Pharmaceutical Co., Ltd.
Offers contract manufacturing services for small molecule APIs, including tizanidine hydrochloride, with a focus on quality control and large-volume production.

b. Indian API Manufacturers

India, with its well-established pharmaceutical industry, supplies a significant proportion of generic APIs, including tizanidine hydrochloride:

Sun Pharmaceutical Industries Ltd.
An established global player with in-house API manufacturing, Sun Pharma produces numerous CNS drugs, including tizanidine hydrochloride, under stringent quality regimes aligned with global standards.
Aurobindo Pharma Ltd.
Known for competitive pricing and high-volume manufacturing, Aurobindo supplies tizanidine hydrochloride API to generic formulators worldwide.
Glenmark Pharmaceuticals
Offers APIs for CNS indications, including tizanidine hydrochloride, with certifications complying with US FDA and EMA standards.

c. European APIs Manufacturers

While less dominant than Asian players, some European companies focus on high-quality, GMP-compliant API production:

Evonik Industries (Germany)
Engages in specialty chemical synthesis, including APIs for neuromodulation drugs. Their focus lies in high-quality manufacturing aligned with stringent regulatory standards.
Siegfried AG (Switzerland)
Provides contract manufacturing services, including small-molecule APIs like tizanidine hydrochloride, emphasizing quality assurance and regulatory compliance.

Excipients and Formulation Component Suppliers

While APIs form the core, excipients used in the formulation of tizanidine hydrochloride tablets significantly impact product stability and bioavailability. Major excipient suppliers include:

JRS Pharma (Germany): Supplies fillers, binders, and disintegrants.
FMC Corporation (US): Provides excipients like MCC (microcrystalline cellulose).
Roquette Frères (France): Supplies premium excipients suitable for CNS drugs.

Finished Dosage Form (FDF) Manufacturers

Large pharmaceutical companies or contract manufacturing organizations (CMOs) assemble API and excipients into consumer-ready products:

Sandoz (Novartis subsidiary): Produces branded and generic tizanidine hydrochloride formulations, leveraging their extensive manufacturing infrastructure.
Mylan (now part of Viatris): Supplies tizanidine hydrochloride tablets globally, with a focus on affordability in emerging markets.
Sun Pharmaceutical Industries: Also undertakes formulation and packaging activities, producing various strengths of tizanidine hydrochloride.
CPhI Contract Manufacturers: Numerous CMOs worldwide offer encapsulation, manufacturing, and packaging of tizanidine hydrochloride formulations adhering to regulatory standards.

Key Regional Supply Dynamics

Asia: Dominates API production due to lower costs, high manufacturing capacity, and expanding regulatory compliance infrastructure.
Europe: Focuses on high-quality, GMP-grade APIs and finished formulations, primarily for markets with stringent regulatory requirements.
North America: Serves as a major market and regulatory hub, with domestic API producers and CMOs ensuring supply chain security.

Supply Chain Challenges and Considerations

Regulatory Compliance: Suppliers must adhere to cGMP standards mandated by authorities such as the US FDA, EMA, and others. Certification status influences procurement decisions.
Supply Security: Dependence on Asian manufacturers raises concerns regarding geopolitical influences, export restrictions, and global logistics disruptions.
Quality Assurance: Ensuring consistent API quality requires rigorous audits and validation processes, critical for regulatory approvals and market access.
Pricing and Cost Dynamics: Competitive pricing from Asian manufacturers influences global procurement strategies, with some buyers prioritizing cost over proximity.

Conclusion

The supply network for tizanidine hydrochloride is multifaceted, encompassing a broad spectrum of global manufacturers. Asian players, chiefly Chinese and Indian companies, dominate API production due to economic advantages and manufacturing capacity. European companies focus on high-quality standards and high-value markets, often serving as reliable suppliers. The choice of supplier hinges on regulatory compliance, quality standards, supply stability, and cost considerations.

Pharmaceutical companies should conduct continuous supplier audits, verify certifications, and diversify sourcing to mitigate risks inherent in global supply chains. As regulatory landscapes evolve and geopolitical factors influence manufacturing, strategic supplier relationships will be paramount to ensure uninterrupted access to quality tizanidine hydrochloride products.

Key Takeaways

The primary API suppliers for tizanidine hydrochloride are located in China, India, and Europe, with China and India leading in volume due to cost advantages.
High regulatory compliance standards are critical; suppliers must hold GMP certifications recognized by major regulatory agencies.
Diversifying supply sources enhances resilience against geopolitical and logistical disruptions.
Asian manufacturers’ competitive pricing makes them attractive, but quality assurance and regulatory alignment remain vital considerations.
Collaboration with experienced CMOs for formulation and packaging adds flexibility and ensures regulatory compliance.

FAQs

1. Who are the leading global suppliers of tizanidine hydrochloride API?
Leading suppliers include Chinese companies like Hefei Zhongxin Pharmaceutical, Indian firms such as Sun Pharma and Aurobindo Pharma, and European manufacturers like Evonik Industries, each offering varying degrees of capacity, quality, and compliance.

2. What factors influence a pharmaceutical company's choice of tizanidine hydrochloride API supplier?
Key factors include regulatory compliance (GMP certification), supply stability, cost, quality consistency, lead times, and supplier reputation.

3. Are there regional restrictions affecting the supply of tizanidine hydrochloride?
Supply chains are affected by trade policies, export restrictions, and geopolitical tensions, especially involving Asian manufacturers. Regulatory requirements also vary across regions.

4. How can pharmaceutical companies mitigate risks in sourcing tizanidine hydrochloride?
Diversify suppliers across regions, establish long-term agreements, conduct regular audits, and maintain stock buffers to accommodate supply fluctuations.

5. What role do excipient suppliers play in the production of tizanidine hydrochloride formulations?
Excipients ensure optimal drug stability, bioavailability, and manufacturability. Reputable excipient suppliers provide consistent quality materials essential for high-quality final products.

References

U.S. Food and Drug Administration (FDA). Current Good Manufacturing Practice (CGMP) Regulations.
European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
IQVIA. Global API Market Report 2022.
PharmSource. API Manufacturing Overview.
CPhI. Contract Manufacturer Directory.

Suppliers and packagers for generic pharmaceutical drug: TIZANIDINE HYDROCHLORIDE