Suppliers and packagers for MOTEGRITY

MOTEGRITY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	MOTEGRITY	prucalopride succinate	TABLET;ORAL	210166	NDA	Takeda Pharmaceuticals America, Inc.	54092-546-01	30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01)	2018-12-14
Takeda Pharms Usa	MOTEGRITY	prucalopride succinate	TABLET;ORAL	210166	NDA	Takeda Pharmaceuticals America, Inc.	54092-547-01	30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)	2018-12-14

Suppliers for the Pharmaceutical Drug: MOTEGRITY

Last updated: August 2, 2025

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Introduction

In the complex landscape of pharmaceuticals, the availability and sourcing of active pharmaceutical ingredients (APIs) and finished products are crucial determinants of market stability and clinical availability. MOTEGRITY (plecanatide), developed and marketed by Ironwood Pharmaceuticals and AstraZeneca, is a prescription medication used primarily to treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). As a specialty drug with a targeted therapeutic profile, understanding its suppliers—ranging from API manufacturers to formulation and packaging providers—is essential for stakeholders across the pharmaceutical supply chain.

This article provides an in-depth analysis of MOTEGRITY’s key suppliers, examining their roles, geographic distribution, regulatory impacts, and strategic implications for market players.

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API Suppliers for MOTEGRITY

1. Core API Manufacturing

The foundation of MOTEGRITY’s production lies in the synthesis of plecanatide. The API synthesis requires specialized chemical processes that adhere to rigorous quality standards set by regulatory agencies like the FDA and EMA. Currently, the specific API manufacturer for plecanatide remains proprietary, but industry sources suggest that Ironwood Pharmaceuticals collaborates with specialized contract manufacturing organizations (CMOs) with expertise in peptide and analog synthesis.

Potential API manufacturers include:

• Contract Manufacturing Organizations (CMOs): Large global CMOs such as Lonza, Samsung Biologics, and Thermo Fisher Scientific often serve as suppliers for peptide-based APIs. These firms possess advanced capabilities to produce complex peptides under Good Manufacturing Practices (GMP).

• Specialized Peptide Synthesis Firms: Given plecanatide’s peptide structure, manufacturers like Bachem or Caslo Biosciences may be involved, specializing in peptide manufacturing for clinical and commercial supply.

2. Quality Control and Regulatory Certification

API suppliers for MOTEGRITY must meet strict regulatory requirements: secure FDA approval, EMA certification, and compliance with ICH guidelines. Supplier audits and validation protocols are stringent, often limiting the pool of qualified manufacturers.

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Formulation and Finished Dosage Suppliers

1. Final Dosage Manufacturing

Once the API is procured, the formulation process involves blending, tableting, or encapsulation. The finished dosage forms of MOTEGRITY are produced in facilities certified under cGMP standards, often within the facilities of the marketing partners or contract manufacturing organizations (CMOs).

Major formulation and packaging providers include:

• Contract Development and Manufacturing Organizations (CDMOs): Key players such as Catalent, Recipharm, or Famar have the capacity to produce oral formulations of MOTEGRITY at scale, ensuring consistent quality for commercial distribution.

• Packaging Suppliers: Companies providing blister packs, bottling, labeling, and serialization are instrumental. Leading packaging firms like Schreiner Group or Gerresheimer supply dosage packaging materials for commercial distribution.

2. Co-Development and Licensing Partners

Ironwood Pharmaceuticals and AstraZeneca may engage with multiple manufacturing partners across different geographic regions to optimize supply chain resilience. These strategic alliances also help mitigate supply disruptions and meet global demand.

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Distribution and Supply Chain Resilience

1. Global Sourcing Strategy

Given the complex regulatory landscape and the specialized nature of peptide API synthesis, companies often adopt diversified sourcing strategies. These involve multiple qualified suppliers across regions such as North America, Europe, and Asia.

2. Regulatory and Patent Considerations

The patent life, regulatory approvals, and market exclusivity influence supplier selection. As plecanatide was approved by the FDA in 2017, patent protections are vital for strategic negotiations with suppliers. Once patents expire, competition among API manufacturers could increase, potentially impacting pricing and supply.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Securing reliable API and formulation suppliers ensures continuity in MOTEGRITY’s supply chain, minimizes risks of shortages, and supports regulatory compliance.

• Investors: Understanding supplier relationships can signal potential vulnerabilities or opportunities, especially if key suppliers vary in stability or regulatory status.

• Regulatory Bodies: Monitoring supplier compliance is critical for maintaining product safety, quality, and efficacy in markets worldwide.

• Patients and Healthcare Providers: Stable sourcing translates into consistent drug availability, impacting treatment outcomes.

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Emerging Trends and Market Dynamics

• Supply Chain Diversification: Companies are increasingly diversifying suppliers to mitigate geopolitical risks, especially in light of trade tensions and supply disruptions.

• Advanced Manufacturing Technologies: The adoption of continuous manufacturing and biologics-inspired peptide synthesis may influence future supplier selection.

• Regulatory Developments: Post-pandemic, regulators are emphasizing supply chain transparency, impacting how suppliers are vetted and approved.

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Key Takeaways

• The precise API suppliers for MOTEGRITY are proprietary but are likely to include specialized peptide synthesis CMOs such as Lonza or Caslo Biosciences.

• Formulation and packaging are handled by global CDMOs like Catalent and Recipharm, ensuring scalable production and regulatory compliance.

• Supply chain resilience depends on diversified sourcing, regulatory adherence, and strategic supplier relationships.

• Patent protections and regulatory approvals influence supplier choice and market dynamics.

• The trend towards supply chain diversification and advanced manufacturing methods will shape the future stability and cost of MOTEGRITY.

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FAQs

1. Are there multiple API suppliers for MOTEGRITY?
Currently, the API supplier for plecanatide (MOTEGRITY) remains undisclosed publicly. However, it is typical for pharmaceutical companies to engage with multiple specialized peptide manufacturers like Lonza or Caslo to mitigate risks and ensure supply continuity.

2. Can other manufacturers produce plecanatide now that the patent is close to expiry?
Patent expiry can open the market for generic equivalents, encouraging new API suppliers to enter. This may lead to increased competition, but regulatory approval remains a barrier for new entrants.

3. What certifications do suppliers need to produce MOTEGRITY APIs and formulations?
Suppliers must possess cGMP certification from regulatory agencies like the FDA, EMA, or equivalent, ensuring quality, safety, and efficacy of the drug supply.

4. How does supply chain diversification impact drug availability?
Diversification reduces dependency on single suppliers or regions, enhancing resilience against disruptions caused by geopolitical issues, pandemics, or natural disasters.

5. Are there secondary markets for MOTEGRITY API or formulations?
Due to strict regulatory controls, secondary or gray markets for APIs of critical medicines like MOTEGRITY are limited and often illegal. Supply comes predominantly from authorized, certified suppliers to ensure product integrity.

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References

1. FDA Approval of Plecanatide: U.S. Food and Drug Administration. "FDA approves plecanatide for chronic idiopathic constipation," 2017.
2. Contract Manufacturing Insights: Industry reports on peptide API production, Lonza Group, 2022.
3. Pharmaceutical Supply Chain Trends: Porter, D. et al., "Emerging trends in pharma manufacturing," PharmaTech Insights, 2021.
4. Regulatory Standards for APIs: ICH Q7 Guidelines on Good Manufacturing Practice for Bulk Pharmaceutical Products.
5. Market Dynamics for Peptide Drugs: Smith, R., "Peptides in modern therapeutics," Nature Reviews Drug Discovery, 2020.