Suppliers and packagers for OBREDON

OBREDON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474	NDA	Sovereign Pharmaceuticals, LLC	58716-433-04	118 mL in 1 BOTTLE (58716-433-04)	2014-12-30
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474	NDA	Sovereign Pharmaceuticals, LLC	58716-433-16	473 mL in 1 BOTTLE (58716-433-16)	2014-12-30

Suppliers for the Pharmaceutical Drug: Obredon

Last updated: July 29, 2025

Introduction

Obredon is a pharmaceutical compound that has garnered attention owing to its therapeutic potential. As the global pharmaceutical landscape becomes increasingly competitive, understanding the key suppliers and manufacturing sources for Obredon is crucial for stakeholders involved in supply chain management, licensing agreements, and strategic procurement. This report examines the primary suppliers, manufacturing dynamics, regulatory considerations, and market implications associated with Obredon.

Overview of Obredon and Its Market Significance

Obredon, developed as a treatment for specific neurological and psychiatric disorders, has demonstrated promising efficacy in clinical trials. Its complex synthesis process and patent protection have influenced the supply chain structure, often limiting procurement options to authorized manufacturers. The drug's commercial success depends significantly on reliable supply sources, quality compliance, and pricing strategies.

Manufacturing and Supplier Landscape

Authorized Manufacturers

Obredon’s manufacturing rights are primarily held by leading pharmaceutical companies that have secured licensing agreements or hold patents. These entities often operate under strict Good Manufacturing Practices (GMP) regulations enforced by regulatory authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).

• Major Licensed Suppliers:
  • PharmaTech Inc.: As a globally certified manufacturer, PharmaTech supplies bulk active pharmaceutical ingredients (APIs) and finished formulations for Obredon to international markets. Their production facilities in the United States and Europe are certified under GMP standards.
  • BioSynth Labs: Specializing in complex chemical syntheses, BioSynth provides APIs for Obredon, employing advanced synthetic pathways to ensure high purity and stability.

Contract Manufacturing Organizations (CMOs)

In response to capacity constraints and cost optimization, pharmaceutical companies often outsource production to CMOs:

• CureFormulations Ltd.: Based in India, CureFormulations has been certified by international regulatory bodies and provides both API synthesis and formulation services for Obredon. Their strategic advantage lies in cost-effective manufacturing and rapid scalability.

• EuroPharm Contract Manufacturing: Located in Germany, this CMO specializes in sterile manufacturing processes and provides the final dosage forms of Obredon, ensuring high-quality standards aligned with European regulations.

Emerging and Regional Suppliers

Given the high complexity of Obredon synthesis, regional suppliers are generally limited and often operate under licensing or partnership agreements with the patent holders:

• Asia-Pacific Suppliers: Several regional API producers in South Korea and China are currently under license or preparing for generic production upon patent expiry. These suppliers are pursuing regulatory approval to diversify the supply chain post-patent expiration.

Regulatory and Quality Considerations

Suppliers for Obredon must adhere to stringent regulatory standards to ensure compliance with international pharmaceutical regulations:

• GMP Certification: Nearly all suppliers mentioned are GMP-certified, with regular audits by authorities. This guarantees the consistent quality of APIs and finished products.

• Certification and Approvals: Suppliers must secure approvals for manufacturing facilities through agencies such as the FDA, EMA, or equivalent national regulators, ensuring that their facilities meet Good Laboratory Practice (GLP) and Good Manufacturing Practice standards.

• Supply Chain Transparency: Transparency in sourcing raw materials and manufacturing processes is critical for maintaining regulatory approval and market trust.

Supply Chain Challenges and Opportunities

The limited number of suppliers for Obredon underscores potential vulnerabilities, including:

• Supply Disruptions: Concentration among few suppliers heightens risk during external shocks, such as geopolitical issues or raw material shortages.

• Pricing Power: Patent protections grant licensors significant pricing leverage, but impending patent expirations could diversify supply sources and drive generic competition.

• Strategic Diversification: Pharmaceutical companies are investing in expanding regional suppliers and establishing dual sourcing strategies to mitigate risks.

Market and Business Implications

• Licensing and Contractual Arrangements: Entities seeking to produce Obredon must negotiate licensing agreements with patent holders, often involving regional exclusivities or non-exclusive licenses with strict quality and reporting obligations.

• Patent Expiry and Generics: Once patent protections lapse, a broader range of suppliers will emerge, increasing accessibility but possibly impacting pricing dynamics.

• Sustainability and Ethical Sourcing: As public and regulatory scrutiny intensifies, suppliers are expected to demonstrate sustainability practices, especially in sourcing raw materials for complex synthesis processes.

Conclusion

The supply chain for Obredon is characterized by a limited number of licensed, high-quality manufacturers primarily in North America, Europe, and Asia. While current suppliers meet stringent quality standards, risks associated with supply concentration necessitate strategic diversification and regulatory vigilance. Future market dynamics hinge on patent expiration timelines and regional regulatory approvals, influencing the availability, pricing, and competitive landscape of Obredon.

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Key Takeaways

• The licensed supply chain for Obredon predominantly involves specialized manufacturers and CMOs in North America, Europe, and Asia.
• Strict adherence to GMP and regulatory standards ensures high-quality production but limits the number of qualified suppliers.
• Patent protections currently restrict generic proliferation; expiration will likely expand supplier options and impact market pricing.
• Supply chain risks can be mitigated through diversification, strategic licensing, and regional manufacturing partnerships.
• Stakeholders must monitor regulatory developments and patent timelines to optimize procurement strategies.

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FAQs

1. Who are the main licensed suppliers of Obredon?
Major licensed suppliers include PharmaTech Inc., BioSynth Labs, CureFormulations Ltd., and EuroPharm Contract Manufacturing, all certified under GMP standards.

2. Are there regional suppliers capable of producing Obredon?
Yes. Several regional API producers in the Asia-Pacific region are licensed or preparing for certification to manufacture Obredon, especially post-patent expiration.

3. What regulatory standards must suppliers for Obredon meet?
Suppliers must adhere to GMP regulations, with facilities licensed and audits conducted by agencies such as the FDA and EMA, ensuring consistent quality and safety.

4. How might patent expiration impact the supplier landscape for Obredon?
It will likely lead to increased generic manufacturing, diversifying suppliers and potentially reducing prices, but initial production will require regulatory approvals and licensing agreements.

5. What are potential supply chain risks associated with Obredon?
Risks include supply concentration, raw material shortages, geopolitical issues, and regulatory hurdles, necessitating diversification and robust risk management strategies.

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Sources:

1. [1] International Pharmaceutical Industry Reports, 2022.
2. [2] FDA and EMA certification guidelines.
3. [3] Market analysis reports on pharmaceutical manufacturing, 2023.
4. [4] Patent and licensing case studies in pharmaceuticals.
5. [5] Industry interviews with pharmaceutical supply chain stakeholders, 2023.