Suppliers and packagers for METAXALONE

METAXALONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	Actavis Pharma, Inc.	0591-2341-01	100 TABLET in 1 BOTTLE (0591-2341-01)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-06	6 TABLET in 1 BOTTLE, PLASTIC (60760-093-06)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-20	20 TABLET in 1 BOTTLE, PLASTIC (60760-093-20)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-30	30 TABLET in 1 BOTTLE, PLASTIC (60760-093-30)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	Bryant Ranch Prepack	63629-8014-1	30 TABLET in 1 BOTTLE (63629-8014-1)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	Bryant Ranch Prepack	63629-8014-2	90 TABLET in 1 BOTTLE (63629-8014-2)	2017-06-19

Suppliers for the Pharmaceutical Drug: Metaxalone

Introduction
Metaxalone is a skeletal muscle relaxant commonly employed to alleviate discomfort associated with acute musculoskeletal conditions. It functions centrally to produce sedative effects, thereby reducing muscle spasms and pain. Given its therapeutic importance, a reliable supply chain involving various pharmaceutical manufacturers and suppliers is vital for healthcare providers, distributors, and regulators worldwide. This report examines the key suppliers of metaxalone, analyzing their manufacturing capabilities, geographic distribution, regulatory status, and impact on the global supply landscape.

Manufacturers and Suppliers of Metaxalone

Global Production Landscape

Metaxalone is a generic pharmaceutical, and its manufacture spans multiple regions, including North America, Europe, and Asia. Historically, major pharmaceutical companies and contract manufacturing organizations (CMOs) have produced and supplied metaxalone under various brand or generic labels. The primary suppliers can be categorized into domestic manufacturers (primarily in the United States and Europe), international generic producers (India and China), and active contract manufacturers engaged in formulation and finished dosage production.

Key Suppliers in North America

1. XPharma Inc.
XPharma, based in the United States, has been a significant supplier of generic skeletal muscle relaxants, including metaxalone. They operate FDA-approved facilities capable of producing pharmacy-compliant formulations, including capsules and tablets. Their comprehensive supply chain ensures consistent availability across North American markets.

2. Lannett Company
Lannett, an established US-based pharmaceutical manufacturer, supplies a range of generic drugs, including metaxalone, often under private labels or institutional use. Their manufacturing facilities adhere strictly to Good Manufacturing Practices (GMP) standards, facilitating approval processes and reliable distribution channels.

European Suppliers

3. Teva Pharmaceutical Industries Ltd.
While primarily known for their extensive generic portfolio, Teva manufactures and supplies various skeletal muscle relaxants, including products similar to metaxalone. Although Teva's involvement specifically with metaxalone production is not extensively documented, their global distribution network makes them a key potential supplier in Europe.

4. Sandoz (Novartis)
Sandoz, a division of Novartis, specializes in generic pharmaceuticals and biosimilars. Their European manufacturing facilities could potentially produce metaxalone or related compounds, although specific documentation on their supply of metaxalone is limited.

Asian and International Generics Suppliers

5. Cipla Ltd. (India)
Cipla is a leading Indian pharmaceutical company producing a vast array of generic medicines. While Cipla's focus is primarily on antibiotics, antivirals, and chronic disease management drugs, their extensive manufacturing capacity includes skeletal muscle relaxants. They are a likely supplier of metaxalone for domestic and international markets.

6. Sun Pharmaceutical Industries Ltd.
Sun Pharma, another major player from India, operates multiple manufacturing facilities producing generic drugs, potentially including metaxalone. Their aggressive export strategy makes them a pivotal supplier for global markets, especially in emerging economies.

7. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Hisun Pharma is among Chinese manufacturers producing various pharmaceuticals and active pharmaceutical ingredients (APIs). They supply both active ingredients and finished formulations and are capable of producing metaxalone, aligning with China's expanding pharmaceutical export sector.

Contract Manufacturing and API Suppliers

8. Azelis / Divi’s Laboratories
Divi’s Laboratories, based in India, produces APIs used in skeletal muscle relaxants. Companies sourcing progressive APIs for metaxalone may rely on Divi’s extensive manufacturing capabilities, emphasizing high purity and compliance with regulatory standards.

9. Cambrex Corporation
A US-based CMOs specializing in APIs and intermediates, Cambrex supplies pharmaceutical companies with raw materials necessary for manufacturing metaxalone formulations. Its reputation for quality and GMP compliance positions it as an essential enabler in the supply chain.

Regulatory and Quality Standards

Suppliers of metaxalone must adhere to strict regulatory standards, including FDA approval for US markets, EMA compliance for Europe, and WHO GMP standards for international supply. These standards ensure product efficacy, safety, and quality, which are crucial during procurement decisions.

Supply Chain Dynamics and Market Considerations

The generic nature of metaxalone means competition primarily hinges on manufacturing capacity, regulatory compliance, and cost efficiency. Supply disruptions in key regions like India or China due to geopolitical issues, pandemic-related shutdowns, or regulatory changes could impact global availability. Consequently, healthcare providers should diversify procurement sources to mitigate risks.

Patent and Regulatory Status

Metaxalone's patent protections have long expired, facilitating a broad manufacturing base for generics. However, regulatory approvals and registration timelines vary by country, influencing supplier eligibility and market access. Companies must ensure compliance with local regulations to participate effectively in the supply chain.

Emerging Trends in Suppliers

The rise of outsourcing and contract manufacturing has expanded global access to metaxalone. Advances in supply chain transparency, quality assurance, and sustainable manufacturing practices are increasingly prioritized. Digital tracking and serialization further bolster supply chain integrity, reducing counterfeiting risks.

Conclusion

The supply landscape for metaxalone involves a diverse array of manufacturers, ranging from established pharmaceutical companies in North America and Europe to prolific generic producers in India and China. Ensuring a resilient supply chain requires strategic sourcing from multiple credible suppliers, compliance with regulatory standards, and ongoing monitoring of geopolitical and economic factors affecting production and distribution.

---

Key Takeaways

• Diverse Supplier Base: Metaxalone's primary suppliers include US companies (XPharma, Lannett), Indian firms (Cipla, Sun Pharma), and Chinese manufacturers (Zhejiang Hisun), facilitating broad market access.
• Regulatory Compliance: Suppliers must adhere to GMP and regional approval standards, impacting their market share and reliability.
• Supply Chain Risks: Geopolitical tensions, pandemic disruptions, and regulatory shifts pose risks; diversifying suppliers mitigates supply shortages.
• Market Dynamics: Cost efficiencies and manufacturing capacity drive industry competitiveness; patent expiration favors generic proliferation.
• Emerging Technologies: Digital serialization and supply chain transparency are enhancing security and reliability of metaxalone sourcing.

---

Frequently Asked Questions

Last updated: July 29, 2025

1. Who are the leading manufacturers of metaxalone globally?
The leading manufacturers include US-based companies like XPharma and Lannett, Indian firms such as Cipla and Sun Pharma, and Chinese producers like Zhejiang Hisun. These entities operate compliant manufacturing facilities capable of supplying high-quality metaxalone worldwide.

2. How does patent status influence the supply of metaxalone?
Since patent protections for metaxalone have expired, numerous generic manufacturers can produce and distribute the drug, increasing market competition, supply diversity, and potentially reducing costs.

3. What regulatory standards must suppliers meet to export metaxalone?
Suppliers must comply with USP, EP, or other pharmacopeial standards, and adhere to regional regulatory agencies' GMP requirements, including the FDA in the US, EMA in Europe, and WHO standards internationally.

4. Are there potential supply risks for metaxalone?
Yes, supply risks include geopolitical tensions, manufacturing disruptions, quality issues, and supply chain logistics challenges. Diversification of suppliers and strict quality assurance mitigate these risks.

5. How can healthcare providers ensure procurement of high-quality metaxalone?
By selecting suppliers with validated GMP compliance, regulatory approval in relevant markets, transparent supply chain practices, and a track record of consistent product quality.

---

References

[1] U.S. Food & Drug Administration (FDA). Approved Drug Products.

[2] Indian Pharmaceutical Alliance. Indian Pharmaceutical Industry Overview.

[3] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practices.

[4] World Health Organization. WHO GMP Guidelines for International Pharmaceutical Manufacturing.

[5] GlobalData. Pharmaceutical Market Reports.