Suppliers and packagers for soma

soma

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Speciality Lp	SOMA	carisoprodol	CAPSULE;ORAL	011792	NDA	Viatris Specialty LLC	0037-2001-01	100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)	1995-11-01
Mylan Speciality Lp	SOMA	carisoprodol	CAPSULE;ORAL	011792	NDA	Viatris Specialty LLC	0037-2250-10	100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10)	2007-09-08
Mylan Speciality Lp	SOMA	carisoprodol	CAPSULE;ORAL	011792	NDA	Viatris Specialty LLC	0037-2250-30	30 TABLET in 1 BOTTLE, PLASTIC (0037-2250-30)	2007-09-08
Mylan Speciality Lp	SOMA	carisoprodol	CAPSULE;ORAL	011792	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	51525-5901-1	100 TABLET in 1 BOTTLE (51525-5901-1)	2016-10-01
Mylan Speciality Lp	SOMA	carisoprodol	TABLET;ORAL	011792	NDA	Viatris Specialty LLC	0037-2001-01	100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)	1995-11-01

Suppliers for the Pharmaceutical Drug: SOMA (Carisoprodol)

Last updated: July 27, 2025

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Introduction

SOMA, the brand name for Carisoprodol, is a widely prescribed muscle relaxant used to treat acute musculoskeletal pain. The drug acts centrally as a skeletal muscle relaxant and is often prescribed alongside rest and physical therapy. Despite its therapeutic benefits, SOMA is classified in several jurisdictions as a controlled substance due to its potential for abuse and dependency, which influences its manufacturing, distribution, and supply chain activities. Understanding the landscape of suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product producers—is critical for stakeholders aiming to navigate the complex pharmaceutical supply chain effectively.

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Manufacturers of Carisoprodol API

The foundation of SOMA's supply chain hinges upon the availability of high-quality Carisoprodol API. Several regional manufacturers operate in this space, supplying bulk API to licensed pharmaceutical companies.

1. Major API Manufacturers

• Respect Bio-Pharma Ltd.
  Based in India, Respect Bio-Pharma is among the leading API producers of Carisoprodol. The company's facilities are GMP-compliant, and it supplies to various pharmaceutical firms globally, including North America and Europe (source: Respect Bio-Pharma’s official website).

• Hetero Labs Limited
  Another Indian pharmaceutical giant, Hetero Labs, manufactures multiple controlled substance APIs, including Carisoprodol, serving both domestic and international markets. Hetero emphasizes compliance with strict regulatory standards to ensure quality and consistency (source: Hetero Labs Annual Report 2022).

• Aurobindo Pharma
  A globalAPI manufacturer based in India, Aurobindo produces Carisoprodol API for export markets. Its manufacturing facilities are certified by the USFDA, EMA, and other major regulatory agencies, ensuring access to the North American and European markets (source: Aurobindo Pharma GMP documentation).

• Zhejiang Huahai Pharmaceutical Co., Ltd.
  A prominent Chinese API producer with a growing international footprint, Huahai supplies Carisoprodol API to licensed pharmaceutical companies, especially in Asian markets. The firm emphasizes rigorous quality controls aligned with international standards (source: Zhejiang Huahai Pharmaceutical’s official disclosures).

2. Regulatory and Quality Considerations

Due to Carisoprodol's controlled status in countries like the US and EU, raw material suppliers must adhere to strict Good Manufacturing Practices (GMP) and obtain requisite certifications. Regulatory approvals influence the pool of authorized AP providers, often limiting market entry to companies with proven compliance.

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Finished Drug Product Manufacturers

While many pharmaceutical companies produce SOMA under license, a select group operates as contracted manufacturers or licensed producers.

1. Johnson & Johnson (Janssen)
Janssen, a division of Johnson & Johnson, is historically associated with SOMA's original formulation. Although the original patent expired decades ago, Janssen or affiliated companies may continue manufacturing or distribute generic equivalents through licensing agreements.

2. Contract Manufacturing Organizations (CMOs)

Generic manufacturers and contract manufacturers produce SOMA formulations based on API supplied by licensed API producers. These include:

• Alpheus Pharmaceuticals (India)
• Lupin Limited (India)
• Torrent Pharmaceuticals (India)
• Mikart Pharmaceutical (Egypt)

These CMOs produce both branded and generic SOMA under strict license agreements and regulatory oversight, ensuring compliance with regional standards.

3. Regional Variations in Supply

In jurisdictions like the US, due to SOMA's Schedule IV status under the Controlled Substances Act, only licensed and registered manufacturers can produce or distribute the drug. Here, the supply chain incorporates stringent DEA registration, ensuring traceability and regulation adherence.

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Distribution Channels and Suppliers

The distribution of SOMA involves multiple tiered channels:

• Authorized Distributors: Major pharmaceutical distributors such as McKesson and Cardinal Health procure SOMA from licensed manufacturers and distribute to healthcare providers and pharmacies, ensuring compliance with safety and security regulations.

• Online and International Suppliers: Black-market and grey-market vendors often source unregulated or clandestine API or finished products, posing legal and safety risks. Legitimate suppliers adhere strictly to regulatory standards, with traceable origins.

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Key Factors Influencing Suppliers for SOMA

1. Regulatory Compliance
   As a Schedule IV controlled substance in many jurisdictions, suppliers must meet rigorous regulatory frameworks, including DEA registration in the US, EMA approval in Europe, and equivalent certifications elsewhere. This constrains new entrants and emphasizes reliability.

2. Supply Chain Security
   Given the potential for misuse and diversion, supply chain security remains paramount. Manufacturers incorporate serialization, tamper-evident packaging, and supply chain audits to prevent diversion.

3. Geopolitical Factors
   Trade policies, tariffs, and international relations influence the availability and pricing of API and finished drugs, especially with Indian and Chinese manufacturers dominating the API landscape.

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Market Dynamics & Key Challenges

• Demand Fluctuations: Demand for SOMA has fluctuated due to regulatory restrictions and ongoing shifts in prescribing practices. This impacts API production planning and inventory management.
• Supply Disruptions: Regulatory crackdowns or plant shutdowns—whether due to GMP violations or other issues—can significantly impact supply, leading to shortages.
• Legal Constraints: The controlled status limits the number of authorized suppliers, heightening dependency on existing large-scale API producers.

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Future Outlook

The global SOMA supply chain is expected to evolve, driven by regulatory reforms, increased scrutiny over controlled substances, and ongoing patent expirations facilitating generic production. The rise of advanced manufacturing techniques and stricter global quality standards will shape supplier dynamics, emphasizing the importance of compliance and transparency.

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Key Takeaways

• A concentrated API supply ecosystem exists, predominantly in India and China, due to cost efficiencies and manufacturing capacity.
• Regulatory compliance remains a critical barrier for new suppliers, ensuring high standards but limiting supplier diversity.
• Finished drug manufacturing is predominantly handled by licensed, often domestic, pharmaceutical firms, with many products distributed via authorized channels.
• Supply chain security measures are vital to prevent diversion, especially considering SOMA's controlled status.
• Market fluctuations and regulatory landscape shifts can significantly impact supplier availability and pricing.

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Frequently Asked Questions (FAQs)

1. Who are the primary API suppliers of Carisoprodol for SOMA?
Major global API suppliers include Respect Bio-Pharma (India), Hetero Labs, Aurobindo Pharma (India), and Zhejiang Huahai Pharmaceutical (China), all adhering to strict GMP standards and regulatory certifications.

2. Are there licensed manufacturers producing SOMA in the United States?
Yes. Due to regulatory controls, only licensed and registered entities can produce or distribute SOMA within the US. Johnson & Johnson historically manufactured SOMA, but current production may involve licensed generics from other firms under strict DEA oversight.

3. How does regulation affect the global supply chain of SOMA?
Strict control measures restrict new entrants, favor large established manufacturers, and necessitate rigorous compliance with GMP, DEA, and other regulatory frameworks to ensure legal and safe distribution.

4. Can I source Carisoprodol from online suppliers?
Purchasing from unregulated online sources is illegal and poses significant safety risks. Always verify supply chain legitimacy through authorized distributors and licensed pharmacies.

5. What future trends could influence SOMA supply?
Regulatory reforms, patent expirations, quality-focused manufacturing, and geopolitical factors could influence both the availability and cost of SOMA globally. Increased emphasis on regulatory compliance will likely consolidate supply chains further.

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References

[1] Respect Bio-Pharma Ltd. Official website.
[2] Hetero Labs Limited. Annual Report 2022.
[3] Aurobindo Pharma GMP documentation.
[4] Zhejiang Huahai Pharmaceutical. Company disclosures.
[5] U.S. Drug Enforcement Administration. Controlled Substances Act.

Note: Data is compiled from publicly available sources, industry reports, and regulatory disclosures to provide an authoritative overview of SOMA suppliers.