Bulk Pharmaceutical API Sources for oliceridine

Bulk Pharmaceutical API Sources for oliceridine

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-16655
AbaChemScene		CS-3571
AbovChem LLC		HY-16655
ChemShuttle		157213

Bulk Active Pharmaceutical Ingredient (API) Sources for: Oliceridine

Last updated: August 2, 2025

Introduction

Oliceridine (commercially known as TRV130) is a novel opioid analgesic developed by Trevena Inc., designed to provide potent pain relief with a reduced risk of typical opioid side effects such as respiratory depression, nausea, and constipation. As a G protein-biased μ-opioid receptor agonist, oliceridine offers a promising advancement over traditional opioids, prompting a keen interest among pharmaceutical manufacturers, compounding pharmacies, and raw material suppliers. The pharmaceutical industry's procurement of high-quality bulk APIs for oliceridine is a critical factor influencing the drug's market availability, cost, and regulatory approval.

This article provides a comprehensive overview of the current sources of bulk API for oliceridine, emphasizing manufacturing capabilities, supply chain considerations, regulatory status, and key suppliers. Understanding these elements is essential for stakeholders aiming to ensure a reliable supply chain for this innovative analgesic.

Regulatory Landscape and Market Demand

Oliceridine received FDA approval in August 2020 for managing acute pain in adult patients requiring opioid analgesics [1]. Its approval spurred increased demand for high-purity API sources capable of meeting stringent pharmacopoeial standards. As the demand rises, the importance of identifying reliable API suppliers has intensified, with a focus on those adhering to Good Manufacturing Practice (GMP) standards and possessing extensive quality certifications.

Manufacturing Considerations for Oliceridine API

Given oliceridine's complex synthetic pathway, bulk API production necessitates sophisticated chemical synthesis routes involving key intermediates, rigorous purification procedures, and strict validation processes. The API manufacturing involves multi-step organic synthesis, typically conducted in facilities with advanced pharmaceutical plant certifications.

Manufacturers must also ensure that their facilities align with regulatory requirements, including certifications from agencies such as the FDA, EMA, or PMDA, depending on the target market. Scale-up capabilities, consistent batch-to-batch quality, and adherence to environmental and safety standards significantly influence the choice of API suppliers.

Key Sources of Oliceridine API

1. Contract Manufacturing Organizations (CMOs)

Several CMOs specialize in the synthesis of complex APIs, including oliceridine. These organizations often serve as primary API suppliers, offering scalable production capacities aligned with pharmaceutical companies’ needs.

• Lonza
  A leading CMO with extensive experience in custom synthesis and large-scale production of complex APIs, Lonza has capabilities compatible with oliceridine synthesis pathways. Their facilities adhere to GMP standards, ensuring high-quality API supply [2].

• Thermo Fisher Scientific (Patheon)
  Known for comprehensive API manufacturing services, Patheon offers process development, scale-up, and GMP production for specialty APIs. Their infrastructure supports complex synthetic routes akin to those needed for oliceridine [3].

2. CRO and API Manufacturers Specializing in Opioids

Certain manufacturers with expertise in opioid APIs also produce intermediates or final APIs suitable for oliceridine.

• Granules India Ltd.
  An Indian API manufacturer with a portfolio spanning opioids and analgesics, Granules India has demonstrated capacity for large-scale synthesis with GMP compliance, making them a potential source for oliceridine intermediates or APIs [4].

• Hetero Labs Limited
  Hetero has experience in producing various APIs, including opioid derivatives, and maintains WHO-GMP accreditation, positioning it as a prospective source for oliceridine API [5].

3. Specialty Chemical Suppliers and Raw Material Providers

While specific sources for oliceridine API are often proprietary, raw material and chemical intermediates used in synthesis are supplied by numerous specialty chemical vendors globally.

• FAG Chemicals
  Provides advanced intermediates and reagents crucial in complex API synthesis. Their role in supporting process development under GMP conditions can be vital for custom API production, including oliceridine [6].

• Alfa Aesar (Thermo Fisher Scientific subsidiary)
  Supplies high-purity chemicals and intermediates common in opioid API synthesis, possibly supporting custom routes for oliceridine manufacturing [7].

4. Emerging Markets and Local API Producers

Growing pharmaceutical markets in India, China, and Southeast Asia are cultivating local API manufacturing capacities, including opioids and analgesics, under increasing regulatory oversight.

• Shandong Xinhua Pharmaceutical (China)
  With an expanding portfolio of opioid APIs, Xinhua may develop capabilities for oliceridine synthesis, contingent on regulatory approvals and process licensing [8].

• Sun Pharmaceutical Industries Ltd.
  As India’s largest pharmaceutical company, Sun has a broad API manufacturing base, with potential for expansion into novel opioid APIs like oliceridine given sufficient R&D investment [9].

Supply Chain and Quality Assurance

The critical success factor for sourcing oliceridine API lies in maintaining a reliable, compliant supply chain. This involves selecting suppliers with proven GMP adherence, comprehensive quality control protocols, and transparent documentation.

• Quality Certifications: ISO certifications, FDA and EMA approvals, and adherence to pharmacopoeial standards (USP, EP, BP) increase supplier credibility.
• Stability and Documentation: Batch stability data, purity profiles, and detailed Certificates of Analysis (CoA) are mandatory for regulatory submissions.
• Supply Security: Strategic partnerships with multiple suppliers mitigate risks associated with geopolitical issues, manufacturing disruptions, or capacity constraints.

Regulatory and Patent Considerations

Although oliceridine received patent protection until 2034 in certain jurisdictions, patent expiration or licensing agreements can influence API sourcing decisions. Suppliers often hold their own patent rights or licenses that impact the availability and cost of APIs. Ensuring alignment with patent laws and securing necessary licensing is vital for legal and compliance considerations.

Conclusion

The sourcing landscape for bulk oliceridine API reflects a combination of established global CMOs, specialized opioid API manufacturers, and emerging regional producers. Quality, regulatory compliance, manufacturing capacity, and supply security are decisive factors influencing supplier selection.

Ongoing innovation and expansion in capacity from reputed pharma-grade API producers are expected to meet the rising demand for oliceridine, especially given its clinical potential and regulatory endorsement. Strategic partnerships and rigorous supplier qualification procedures are imperative for pharmaceutical companies aiming for a reliable supply chain to support the commercial success of oliceridine.

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Key Takeaways

• High-quality GMP-certified suppliers like Lonza and Thermo Fisher Scientific are primary candidates for bulk oliceridine API.
• Regional manufacturers, especially in India and China, are expanding capabilities, potentially lowering costs and increasing supply diversification.
• Supplier due diligence—including regulatory compliance, quality systems, and capacity—is critical to prevent supply disruptions.
• Patent and licensing considerations may influence sourcing options and costs.
• Emerging APIs and intermediates suppliers can support process development, but validation and regulatory approval are essential before commercialization.

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FAQs

1. Who are the leading global suppliers of oliceridine API?
Top recognized suppliers include Lonza and Thermo Fisher Scientific (Patheon), which possess advanced GMP manufacturing capabilities for complex APIs like oliceridine [2][3].

2. What factors should be considered when selecting an API supplier for oliceridine?
Key factors include GMP compliance, manufacturing capacity, quality control standards, regulatory approvals, supply chain stability, and licensing agreements [2][3].

3. Are there regional suppliers capable of producing oliceridine API at lower costs?
Yes, emerging markets such as India and China have OEMs with growing capabilities; however, rigorous quality and regulatory validation are essential before commercial use [4][5][8].

4. How does patent protection impact API sourcing for oliceridine?
Patent rights influence licensing and exclusive manufacturing rights, affecting API availability and cost. Suppliers must operate within legal patent frameworks unless patents expire or are licensed [10].

5. What future trends might influence oliceridine API sourcing?
Increased consolidation among API manufacturers, technological advancements in synthesis, and regulatory enhancements will shape sourcing strategies, emphasizing quality, scalability, and supply security [1].

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References

[1] U.S. Food and Drug Administration. (2020). FDA approves Trevena’s Oliceridine for severe acute pain.
[2] Lonza Group. (2023). API manufacturing capabilities.
[3] Thermo Fisher Scientific. (2023). API services and custom synthesis.
[4] Granules India Ltd. Annual Report. (2022).
[5] Hetero Labs Limited. Company profile. (2023).
[6] FAG Chemicals. Product overview. (2023).
[7] Alfa Aesar. Chemical intermediates catalog. (2023).
[8] Shandong Xinhua Pharmaceutical. Corporate profile. (2022).
[9] Sun Pharmaceutical Industries Ltd. Annual report. (2022).
[10] PatentScope. (2023). Patent status of oliceridine.