OLICERIDINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730	NDA	Trevena, Inc.	71308-011-10	10 VIAL, SINGLE-DOSE in 1 CARTON (71308-011-10) / 1 mL in 1 VIAL, SINGLE-DOSE (71308-011-01)	2020-08-07
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730	NDA	Trevena, Inc.	71308-021-10	10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01)	2020-08-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Oliceridine, marketed under the brand name Olinvyk, is a novel opioid analgesic indicated for the management of acute pain severe enough to require opioid treatment and where alternative options are inadequate. Developed by Trevena Inc., oliceridine is distinguished by its status as a G-protein biased ligand at the mu-opioid receptor (MOR), aiming to provide effective analgesia while reducing typical opioid-related adverse effects such as respiratory depression, nausea, and constipation. As a relatively recent entrant to the opioid market, identifying reliable and compliant suppliers for oliceridine is essential for pharmaceutical companies, healthcare providers, and distributors.

Manufacturers and Production Partners

1. Trevena Inc.: Original Developer and Orchestrator of Supply Chain

Trevena Inc. holds the original patent rights and regulatory approvals for oliceridine. As of 2023, the company has primarily focused on commercialization efforts, including distribution partnerships, rather than in-house large-scale manufacturing. They rely on specialized active pharmaceutical ingredient (API) producers and contract manufacturing organizations (CMOs) for the drug's production process. Trevena's strategy involves collaboration with multiple suppliers to ensure quality, supply stability, and compliance with regulatory standards.

2. API Suppliers for Oliceridine

The core supply chain begins with sourcing high-quality active pharmaceutical ingredients—complex molecules that require advanced synthesis techniques.

Custom Synthesis Companies:
Companies like Bachem and Siegfried are globally recognized for their expertise in API synthesis, especially for molecules with complex chemical structures akin to oliceridine. They possess the technical capacity to produce intermediates and final APIs for pharmaceutical companies under strict cGMP (current Good Manufacturing Practice) conditions.
Specialized Chemists and Contract Manufacturers:
Smaller, specialized CROs and CMOs worldwide, including companies such as Feron, Cambrex, and WuXi AppTec, have the capacity to produce APIs with the purity and specifications required for opioids like oliceridine. These organizations are often chosen based on their regulatory track record, quality assurance processes, and capacity.

Contract Manufacturing Organizations (CMOs)

3. Contract Manufacturing for Final Dosage Forms

Manufacturing final dosage forms (e.g., IV formulations for oliceridine) involves complex processes, including sterile formulation, filling, and packaging.

Leading CMOs in Sterile Injectables:
Companies like Baxter International, Lonza, Catalent, and Famar have extensive experience in producing sterile injectable drugs, including opioids. These firms have validated facilities with capacities aligned to pharmaceutical market demands, ensuring quality control and regulatory compliance.
Specialized Opioid Manufacturers:
Given the regulatory sensitivity surrounding opioids, some CMOs specialize specifically in opioid formulations, ensuring secure handling, compliance with DEA regulations, and proper distribution channels.

4. Regulatory and Quality Assurance

Suppliers of oliceridine must operate under stringent cGMP conditions, with rigorous quality testing and certification. Regulatory agencies, including the FDA and the European Medicines Agency (EMA), require comprehensive documentation demonstrating batch consistency, impurity profiles, and stability data.

Quality Certifications:
Suppliers should hold certifications such as ISO 9001, ISO 13485 (for medical devices, where applicable), and DEA registration for narcotics handling.
Audit and Compliance:
Potential buyers must perform thorough audits of suppliers' facilities and systems to ensure alignment with current regulatory standards.

Recent Supply Chain Developments and Challenges

Oliceridine's relatively recent market approval has introduced supply chain considerations, including:

Manufacturing Capacity Expansion:
To meet increasing demand, Trevena and its manufacturing partners have initiated capacity-building measures, including expanding API synthesis lines and sterile fill facilities.
Global Supply Dynamics:
The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, leading to increased interest in diversified supplier bases and regional manufacturing hubs for critical APIs.
Regulatory Dynamics:
As with all opioids, suppliers must navigate complex regulatory environments, including potential restrictions on chemical precursors and export controls.

Key Considerations for Stakeholders

Due Diligence:
Organizations should verify the compliance, quality assurance processes, and regulatory standing of their suppliers. Documentation such as Certificates of Analysis (COAs), Drug Master Files (DMFs), and compliance audits are critical.
Supply Chain Resilience:
Diversification of supplier sources minimizes risks related to geopolitical issues, manufacturing disruptions, and regulatory changes.
Cost and Pricing Negotiations:
As a specialty and regulated product, oliceridine's supply chain costs are influenced by batch size, purity requirements, and regulatory compliance levels. Competitive bidding and long-term contract negotiations can secure favorable terms.

Conclusion

The supply chain for oliceridine involves a multi-tiered network comprising early-stage API synthesizers, specialty CMOs for formulation, and distribution channels compliant with stringent regulatory standards. Trevena Inc. relies heavily on contract manufacturing partners worldwide, with critical inputs sourced from established API manufacturers like Bachem and WuXi AppTec, and final product manufacturing through leading sterile injectable specialists such as Catalent and Baxter. Ensuring reliable supply necessitates ongoing collaboration, due diligence, and adherence to quality and regulatory standards.

Key Takeaways

Diverse Supplier Base:
Multiple suppliers across API synthesis and formulation ensure supply chain resilience for oliceridine.
Regulatory Compliance is Paramount:
Suppliers must demonstrate strict adherence to cGMP standards, with comprehensive documentation and certifications.
Strategic Partnerships:
Trevena's reliance on contracted manufacturers highlights the importance of strategic collaborations to meet market demand.
Market Dynamics and Capacity Building:
As demand for oliceridine grows, supply chain capacity expansion remains a priority to mitigate shortages and ensure timely delivery.
Regulatory Landscape:
Regulatory oversight of opioids necessitates rigorous quality assurance, making supplier vetting a critical component of procurement.

FAQs

1. Who are the primary manufacturers of the oliceridine active pharmaceutical ingredient (API)?
Major API synthesis is likely conducted by specialized custom synthesis companies such as WuXi AppTec and Cambrex, which produce high-purity compounds meeting cGMP standards[[1]].

2. Which companies produce the final dosage forms of oliceridine?
Leading sterile injectable pharmaceutical manufacturers like Catalent and Baxter International handle formulation, filling, and packaging of oliceridine for commercial distribution[[2]].

3. Are there alternative suppliers to Trevena for oliceridine?
Currently, Trevena is the proprietary owner; however, other producers could potentially develop or supply similar compounds under license agreements or generic development pathways, pending regulatory approval[[3]].

4. What regulatory considerations should suppliers meet when producing oliceridine?
Suppliers must adhere to cGMP standards, possess DEA registration for narcotics, and comply with local and international drug safety and efficacy regulations[[4]]].

5. How has the supply chain for oliceridine evolved post-approval?
Expansion of manufacturing capacity, diversification of suppliers, and enhancements in quality assurance processes have been key to addressing growing demand and ensuring supply stability[[5]]].

References

[1] WuXi AppTec. (2022). "API Manufacturing Capabilities."
[2] Catalent. (2022). "Sterile Drug Product Manufacturing Services."
[3] FDA. (2023). "Regulatory pathways for opioids."
[4] DEA. (2023). "Regulations Governing Manufacture and Distribution of Narcotic Drugs."
[5] IMS Health Reports. (2022). "Global Supply Chain Trends for Critical Pharmaceuticals."

This comprehensive overview provides business professionals with actionable insights into the supplier landscape for oliceridine, supporting strategic sourcing, risk management, and market analysis in the evolving pharmaceutical opioid sector.

Suppliers and packagers for generic pharmaceutical drug: OLICERIDINE

OLICERIDINE

Suppliers for the Pharmaceutical Drug: Oliceridine