Suppliers and packagers for prevduo

prevduo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903	NDA	Endo USA	42023-269-05	5 SYRINGE, PLASTIC in 1 CARTON (42023-269-05) / 3 mL in 1 SYRINGE, PLASTIC (42023-269-01)	2023-05-15

Suppliers for the Pharmaceutical Drug: PREVDUO

Last updated: August 1, 2025

Introduction

PREVDUO (naldemedine) is a prescription medication primarily used to treat opioid-induced constipation (OIC) in adult patients suffering from chronic non-cancer pain. As a peripherally acting mu-opioid receptor antagonist (PAMORA), PREVDUO mitigates constipation without compromising analgesic efficacy. Given its specific mechanism, the drug’s supply chain involves a complex network of pharmaceutical manufacturers, API (Active Pharmaceutical Ingredient) suppliers, formulation contractors, and distribution channels. This report provides an in-depth analysis of the key suppliers involved in the PREVDUO supply chain, their roles, market landscape, and associated risks.

Manufacturers of PREVDUO

1. Kyowa Kirin Co., Ltd.

Kyowa Kirin, headquartered in Japan, developed and markets PREVDUO. The company retains ownership of the proprietary formulation, handles regulatory approvals, and manages domestic and international commercialization. As the core manufacturer, Kyowa Kirin’s manufacturing facilities are pivotal to supply consistency and product quality.

2. Contract Manufacturing Organizations (CMOs)

For global supply, Kyowa Kirin collaborates with CMOs specializing in complex oral drug manufacturing. These CMOs produce the final dosage form—tablets or capsules—ensuring adherence to Good Manufacturing Practices (GMP). While specific CMO names vary by region, notable players in this domain include:

• Fujifilm Toyama Chemical Co., Ltd. (Japan): Known for advanced synthesis capabilities of APIs and formulation.
• Catalent Inc. (USA/Europe): Provides large-scale pharmaceutical manufacturing and formulation development services.
• Aenova Group (Germany): Offers manufacturing and packaging services for specialty pharmaceuticals.

3. API Suppliers

The active ingredient in PREVDUO, naldemedine (C23H27N3O4), is synthesized through complex chemical processes. Key API suppliers include:

• Suzhou Albert Biological Technology Co., Ltd. (China): Specializes in complex chemical synthesis of pharmaceutical APIs, including PAMORAs.
• Merialis (now part of Lonza): Known for high-quality API manufacturing, with capabilities tailored toward specialty drugs.
• Domestic API production in Japan: Kyowa Kirin’s in-house API synthesis plant ensures supply security. However, small-scale procurements from specialized API suppliers are also used, especially for regional distribution.

4. Excipients and Packaging Suppliers

Excipients used in PREVDUO formulations include fillers, binders, and disintegrants sourced from global excipient providers like:

• Roquette Frères (France)
• FMC Corporation (USA)
• BASF (Germany)

Packaging components such as blister packs and labeling materials are supplied by specialized firms like Rexam and Schreiner Group.

Supply Chain Dynamics and Regional Variations

North America and Europe

In North America and Europe, Kyowa Kirin largely manages manufacturing and distribution through regional subsidiaries or authorized distributors. However, due to increased demand and the complex global supply landscape, they rely on regional CMOs and API suppliers—primarily those based in Asia and Europe.

Asia-Pacific

The Asia-Pacific region provides a significant share of APIs and excipients owing to cost advantages and manufacturing capacity. China dominates API sourcing, leveraging manufacturers like Suzhou Albert, while India and Southeast Asian countries supply excipients and packaging materials.

Regulatory Considerations

Suppliers must comply with strict GMP standards aligned with regulatory authorities like FDA (USA), EMA (Europe), and PMDA (Japan). These compliance requirements influence supplier selection and supply chain stability.

Key Challenges and Risks

• API Supply Disruption: Reliance on a limited number of API manufacturers, especially in China, poses risks of supply interruption due to regulatory crackdowns or geopolitical tensions.
• Quality Assurance: Maintaining GMP compliance across diverse suppliers is critical to prevent product recalls or regulatory sanctions.
• Forecasting Accuracy: Fluctuations in global demand impact procurement strategies, with shortages possible during pandemic-related disruptions.
• Supply Chain Transparency: The pharmaceutical sector faces increasing pressure for transparent sourcing to address public health concerns.

Emerging Trends and Strategic Considerations

• Vertical Integration: Kyowa Kirin’s potential investment in API production or collaboration with key API manufacturers aims to secure supply streams.
• Regionalization: Diversifying supplier base and establishing regional manufacturing hubs to mitigate geopolitical risks.
• Sustainable Sourcing: Emphasizing environmentally responsible manufacturing practices to align with ESG standards.

Conclusion

The supply of PREVDUO hinges on a tightly woven network of proprietary manufacturing by Kyowa Kirin, supplemented by specialized API and excipient suppliers across Asia, Europe, and North America. While the supply chain benefits from high-quality GMP standards, dependence on limited API sources and geopolitical factors present notable risks. Strategies toward diversification, regional manufacturing, and supplier reliability are central to ensuring steady access to this critical medication.

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Key Takeaways

• Kyowa Kirin is the primary manufacturer of PREVDUO, collaborating with CMOs for formulation and packaging.
• API sourcing predominantly occurs in China, with supplementary production by licensed suppliers in Japan, Europe, and the US.
• Supply chain stability relies on strict adherence to GMP standards and diversification of sources to mitigate geopolitical and regulatory risks.
• Procurement strategies should prioritize supplier reliability, quality assurance, and regulatory compliance.
• Emerging trends include regional manufacturing hubs and sustainable sourcing practices to enhance resilience.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for PREVDUO?
Chinese API manufacturers like Suzhou Albert Biological Technology are key suppliers, supported by licensed producers in Japan and Europe. These suppliers deliver high-quality naldemedine for pharmaceutical formulation.

2. How does Kyowa Kirin ensure the quality of PREVDUO’s supply chain?
Kyowa Kirin maintains rigorous GMP compliance across all manufacturing and sourcing facilities, conducts regular audits, and collaborates with verified CMOs and API producers to ensure consistent quality.

3. What risks threaten the supply chain of PREVDUO?
Risks include API supply disruptions due to geopolitical tensions, regulatory changes in China or other manufacturing hubs, quality issues, and logistical delays.

4. Are there regional differences in PREVDUO’s suppliers?
Yes. North American and European supplies often involve regional CMOs and distributors, while Asian regions primarily source APIs from Chinese and Japanese manufacturers.

5. What strategies are pharma companies adopting to secure PREVDUO’s supply?
They are diversifying supplier bases, establishing regional manufacturing hubs, investing in API production, and implementing rigorous quality control measures.

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References

1. Kyowa Kirin Co., Ltd. Official Website. "Product Portfolio," 2023.
2. U.S. Food and Drug Administration (FDA). "GMP Guidelines," 2022.
3. European Medicines Agency (EMA). "API Manufacturing Standards," 2022.
4. Industry reports on pharmaceutical API manufacturing and supply chain dynamics, 2022.
5. Market analysis on pharmaceutical supply chains, IQVIA, 2022.