Bulk Pharmaceutical API Sources for ULTRAM ER

Bulk Pharmaceutical API Sources for ULTRAM ER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		UC456_SIGMA
Sigma-Aldrich		42965_SIGMA
Hangzhou APIChem Technology		AC-796
AKos Consulting & Solutions		AKOS015907739
Mcule		MCULE-3504250719

Bulk Active Pharmaceutical Ingredient (API) Sources for ULTRAM ER (Tramadol Extended-Release)

Last updated: July 28, 2025

Introduction

ULTRAM ER (tramadol extended-release) is a prescription analgesic used to manage moderate to severe chronic pain. Its efficacy relies on a complex formulation of tramadol hydrochloride, a synthetic opioid agonist affecting central nervous system pathways, combined with extended-release technology to provide sustained analgesia. Ensuring a reliable, quality supply of the active pharmaceutical ingredient (API)—tramadol hydrochloride—is critical for manufacturers and stakeholders in the pharmaceutical supply chain. This report offers an in-depth overview of the primary global sources of tramadol APIs suitable for ULTRAM ER production, analyzing supply chain dynamics, quality standards, and regulatory landscapes.

Overview of Tramadol Hydrochloride API Market

The global tramadol hydrochloride API market is characterized by a limited number of high-quality producers, primarily located in Asia, Europe, and North America. The API must meet stringent Good Manufacturing Practice (GMP) standards, equivalent to those required for finished pharmaceutical products (FPP). Dominant suppliers supply APIs to both generic manufacturers and branded drug producers, with some focusing exclusively on niche markets.

Key factors influencing API sourcing include:

• Regulatory compliance (FDA, EMA, PMDA)
• Cost competitiveness
• Production capacity
• Quality control systems and certifications
• Lead times and supply reliability

The following sections highlight key players and sourcing options for tramadol hydrochloride API.

Major API Suppliers for Tramadol Hydrochloride

1. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Kangle Pharmaceutical is a prominent Chinese manufacturer specializing in opioids and derivatives, including tramadol hydrochloride. The company operates under strict GMP standards, with certifications aligned with US FDA and EU regulations, allowing its APIs for export to Western markets.

Capabilities:

• Production capacity exceeding several tons monthly, making it suitable for large-scale ULTRAM ER manufacturing.
• Emphasis on quality assurance, with extensive analytical and stability testing.
• Strong export footprint, including North America, Europe, and Asia.

Regulatory Status: API produced by Zhejiang Kangle often carries CE and FDA certificates, facilitating international approval processes.

2. Jiangsu Nhwa Pharmaceutical Co., Ltd. (China)

Overview: Jiangsu Nhwa is a leading Chinese API producer with diversified portfolio including opioids. It is GMP-certified and has received regulatory approvals for export to the US and Europe.

Capabilities:

• High-quality tramadol hydrochloride API compliant with international standards.
• Proven track record of large batch production.
• Robust R&D infrastructure supporting continuous process improvements.

Regulatory Status: Certified by Chinese authorities with audit-ready documentation for global markets.

3. Sun Pharmaceutical Industries Ltd. (India)

Overview: Sun Pharma is among the top Indian pharmaceutical companies globally, with significant API manufacturing capabilities. Its tramadol hydrochloride API facilities adhere to WHO-GMP, US FDA, and EU standards.

Capabilities:

• Extensive API manufacturing infrastructure.
• Certified for global supply, including US, EU, and ROW (rest of world) markets.
• Focus on cost-effective production while maintaining quality.

Regulatory Status: Approved by multiple international agencies, supporting ULTRAM ER OEM production.

4. Micro Labs Ltd. (India)

Overview: Micro Labs has a strong presence in the generic API space, including tramadol hydrochloride, with facilities compliant with global standards.

Capabilities:

• Reliable supply chain with consistent quality.
• Focus on compliance and rigorous quality assurance.
• Competitive pricing advantageous for large-volume procurement.

Regulatory Status: Certified by global regulators; production batches are compliant with ISO, WHO-GMP, and other standards.

5. Hubei Y står Pharmaceutical Co., Ltd. (China)

Overview: This Chinese company has gained recognition for opioid APIs, including tramadol hydrochloride, with a focus on research-driven manufacturing.

Capabilities:

• Modern manufacturing facilities.
• High purity APIs with minimal impurities.
• Capacity suitable for large bulk orders.

Regulatory Status: Certified to meet international quality standards, facilitating export to regulated markets.

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Supply Chain Considerations and Quality Standards

The reliability of API supply for ULTRAM ER hinges on adherence to global regulatory standards and consistent quality. Suppliers must comply with:

• US FDA Current Good Manufacturing Practices (cGMP): Essential for APIs supplied to US markets.
• European Medicines Agency (EMA) standards: Necessary for European Union compliance.
• WHO-GMP Certification: Offers a baseline for quality in developing markets.
• Certificates of Analysis (CoA): Validation of purity, potency, and impurity profiles.

Risk mitigation strategies include multi-sourcing, detailed due diligence, and ongoing supplier qualification programs.

Regulatory Landscape

Regulatory acceptance is pivotal for API producers intending to supply ULTRAM ER formulations globally. Suppliers must demonstrate:

• Robust quality control systems.
• Stability and consistency in production.
• Compliance with environmental and safety standards.
• Proper documentation for batch traceability.

In recent years, regulatory agencies have heightened scrutiny on opioids, further emphasizing the importance of certified and compliant API sources.

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Emerging Trends and Future Outlook

The API sourcing landscape is evolving with increased emphasis on:

• Global Quality Standards: Suppliers investing heavily in upgrading facilities to meet stricter international regulations.
• Sustainable Production: Incorporation of environmentally sustainable practices.
• Supply Chain Resilience: Diversification of sources to mitigate geopolitical risks and pandemic-related disruptions.
• Biotechnological Advances: Exploration of biosynthetic pathways for opioid APIs, potentially reducing dependency on traditional chemical synthesis.

The growing demand for ULTRAM ER, driven by an aging population and chronic pain management needs, will likely sustain or increase API procurement volumes, prompting continued expansions of capacity among key suppliers.

Key Takeaways

• China and India remain dominant API sources for tramadol hydrochloride, with multiple GMP-certified manufacturers capable of supplying ULTRAM ER-grade APIs.
• Regulatory compliance and quality assurance are critical, with suppliers adhering to cGMP, WHO-GMP, and other stringent standards.
• Diversifying API suppliers and establishing strong qualification protocols will mitigate supply chain risks.
• Emerging sustainable and biotechnological production methods may reshape the API sourcing landscape in the coming decade.

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FAQs

1. What are the primary regions supplying tramadol hydrochloride API for ULTRAM ER?
The primary suppliers are based in China and India, with some European and North American producers maintaining niche capacities and high-quality standards.

2. How important is GMP certification for API suppliers of ULTRAM ER?
GMP certification ensures that APIs meet safety, quality, and efficacy standards required by regulatory agencies, making it essential for suppliers aiming to export to regulated markets.

3. Can API quality directly influence ULTRAM ER efficacy and safety?
Yes. High-quality APIs with minimal impurities and consistent potency are crucial for the safety, efficacy, and regulatory approval of ULTRAM ER formulations.

4. Are there concerns regarding geopolitical factors affecting API supply chains?
Yes. Trade tensions, export restrictions, and pandemic disruptions can impact supply continuity. Diversification and qualification of multiple suppliers mitigate such risks.

5. What future developments might influence API sourcing for tramadol hydrochloride?
Advances in biosynthesis, stricter regulatory standards, and sustainability initiatives will shape future sourcing strategies, potentially expanding options or driving innovation in manufacturing.

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References

[1] MarketWatch. "Global Tramadol Hydrochloride API Market Analysis." 2022.
[2] European Medicines Agency. "Guidelines on Good Manufacturing Practice." 2021.
[3] US Food and Drug Administration. "FDA Expectations for Active Pharmaceutical Ingredient Quality." 2022.
[4] IQVIA. "API Manufacturing Capacity and Market Dynamics." 2023.
[5] World Health Organization. "WHO Certification for Good Manufacturing Practices." 2021.