Bulk Pharmaceutical API Sources for plecanatide

Bulk Pharmaceutical API Sources for plecanatide

Vendor	Vendor Homepage	Vendor Sku	API Url
Chemenu Inc.		CM100987
THE BioTek		bt-278805
Chem-Space.com Database		CSSB02495333961
Smolecule		S539864
BOC Sciences		467426-54-6

Bulk Active Pharmaceutical Ingredient (API) Sources for Plecanatide

Last updated: July 29, 2025

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Introduction

Plecanatide, a synthetic peptide analog designed to mimic endogenous uroguanylin, functions as a guanylate cyclase-C (GC-C) receptor agonist primarily employed for treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). As a peptide-based API, plecanatide's sourcing involves strict regulations, complex manufacturing processes, and reliable supply chains. The global landscape of API suppliers plays a vital role in ensuring pharmaceutical quality, regulatory compliance, and cost efficiency.

This article comprehensively explores the primary sources for bulk plecanatide API, analyzing key manufacturers, geographical distribution, manufacturing capabilities, regulatory compliance, and market dynamics. Such insight supports pharmaceutical companies' procurement strategies and informs stakeholders about the competitive landscape and risk factors associated with sourcing plecanatide.

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Manufacturers of Plecanatide API

1. Synergy Pharmaceuticals (Now Part of Bausch Health)

Overview:
Synergy Pharmaceuticals originally developed plecanatide and advanced its clinical development, culminating in FDA approval in 2017 under the trade name Trulance. Post-acquisition by Bausch Health, the company continued to leverage existing manufacturing infrastructure and supplier relationships for API production.

API Supply Capabilities:
Although primarily responsible for the commercial formulation and commercialization, Synergy/ Bausch Health maintains internal API manufacturing for domestic supply. Their capabilities include high-quality peptide synthesis adhering to Good Manufacturing Practices (GMP).

Regulatory Standing:
API manufactured under strict GMP conditions with subsequent approvals for global markets.

Source Viability:
While direct procurement is possible, Bausch Health typically supplies APIs to approved partners. Their production capacities are substantial, but exclusivity agreements may restrict third-party sourcing.

2. Contract Manufacturing Organizations (CMOs)

Due to the complex synthesis of peptides like plecanatide, many pharmaceutical companies rely on specialized CMOs with demonstrated expertise in peptide API manufacturing.

Key Players:

• Patheon (a part of Thermo Fisher Scientific):
  Offers peptide synthesis and GMP API manufacturing with advanced solid-phase peptide synthesis (SPPS) capabilities. Their extensive infrastructure supports complex peptide APIs, including plecanatide, with scalable production.

• Bachem:
  Specializes in peptide synthesis for APIs with global GMP facilities. Bachem provides custom peptide APIs to pharmaceutical developers, emphasizing quality and regulatory adherence.

• CordenPharma (now part of the International Chemical Investors Group):
  Has established a dedicated peptide API manufacturing unit capable of producing complex APIs such as plecanatide, leveraging decades of peptide synthesis expertise.

• Lonza:
  Provides peptide API manufacturing with a focus on high purity, scale, and compliance. Their multi-platform synthesis technologies support complex peptide APIs.

Selection Considerations:
Contract manufacturing is preferred for early-stage development and commercial scale supply. Validation of capacity, regulatory track record, and quality control are critical.

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Geographical Distribution of API Sourcing

North America:
The U.S. dominates due to regulatory familiarity, existing manufacturing infrastructure, and recent market approval by the FDA. Bausch Health’s in-house capabilities are primarily situated within North America.

Europe:
Major peptide manufacturing hubs exist across Switzerland, Germany, and the UK, with companies like Bachem and CordenPharma operating state-of-the-art GMP facilities.

Asia:
While Asia—particularly China and India—hosts numerous peptide contract manufacturers, only select entities meet the stringent GMP standards necessary for APIs like plecanatide. However, due to cost advantages and capacity, many pharmaceutical players consider Asian CMOs for early-stage or non-core supply.

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Regulatory and Quality Considerations

Sourcing plecanatide API mandates compliance with GMP standards per ICH guidelines and local regulations. Reliable suppliers provide Certificates of Suitability (CEPs) or Drug Master Files (DMFs) registered with agencies like the FDA and EMA, indicating adherence to quality systems.

Quality concerns are paramount for peptides, as their complex synthesis can lead to impurities like misfolded peptides, truncated sequences, or aggregation. Suppliers with proven quality management systems and transparent documentation mitigate supply chain risks.

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Market Dynamics and Supply Chain Risks

Supply Security:
The relatively concentrated supplier base, especially among specialized peptide CMOs, increases supply chain vulnerabilities. Disruptions at manufacturing sites—due to capacity constraints, regulatory actions, or geopolitical factors—pose risks.

Cost Implications:
API costs vary based on synthesis complexity, scale, and supplier location. European and North American providers tend to have higher manufacturing costs but offer enhanced regulatory credibility, whereas Asian suppliers provide cost advantages but may face higher scrutiny or logistical hurdles.

Strategic Sourcing:
Pharmaceutical companies consider dual sourcing, establishing relationships with multiple qualified suppliers to mitigate risks associated with demand surges or supply chain disruptions.

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Emerging Trends & Future Outlook

• Vertical Integration:
  Companies involved in both API synthesis and formulation aim for supply chain control and quality assurance.

• Technological Advances:
  Innovations in peptide synthesis—such as flow chemistry and automation—may expand manufacturing capacity, reducing costs and lead times for plecanatide API.

• Regulatory Harmonization:
  Increased acceptance of international GMP standards facilitates global sourcing, expanding options for reliable suppliers.

• Supply Chain Resilience:
  Post-pandemic supply chain strategies focus on diversification and increased inventory buffers, especially for high-demand APIs like plecanatide.

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Conclusion

The sourcing of bulk plecanatide API involves a mix of internal manufacturing, established peptide CMOs, and potentially trusted regional suppliers. The primary manufacturers are concentrated in North America and Europe, with strategic Asian suppliers complementing supply chains for cost considerations. Ensuring regulatory compliance, high quality standards, and supply chain resilience remains critical in selecting API sources.

As plecanatide's market expands, the demand for reliable, scalable, and compliant API sources will intensify, fostering growth among specialized peptide manufacturers globally. Strategic partnerships, technological innovations, and regulatory harmonization will shape future procurement strategies and supply chain stability.

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Key Takeaways

• Supplier Focus: Bausch Health (Synergy Pharmaceuticals) is the primary in-house source; however, numerous CMOs like Bachem, CordenPharma, Patheon, and Lonza serve as reliable external suppliers.

• Geographical Advantage: North America and Europe host most GMP-compliant peptide manufacturing, with Asian CMOs offering cost-effective alternatives.

• Regulatory Vigilance: Suppliers with proven GMP compliance, regulatory approvals, and transparent documentation are preferred to ensure uninterrupted supply and compliance.

• Supply Chain Management: Diversification and dual sourcing protect against disruptions, particularly given the complexity of peptide synthesis.

• Future Trends: Technological advances and increasing regulatory acceptance are expected to expand manufacturing capacity and supply resilience.

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FAQs

1. Who are the leading manufacturers of plecanatide API globally?
The primary source is Bausch Health, originating from Synergy Pharmaceuticals. Many pharmaceutical companies rely on specialized peptide CMOs such as Bachem, CordenPharma, Patheon, and Lonza for API production, especially for scale-up and contract manufacturing.

2. What regulations govern the manufacturing of plecanatide API?
Manufacturing must adhere to Good Manufacturing Practices (GMP) as outlined by ICH guidelines, with suppliers often holding Certificates of Suitability (CEPs) and Drug Master Files (DMFs) registered with agencies like the FDA and EMA.

3. Are Asian peptide manufacturers reliable sources for plecanatide API?
Yes, several Asian CMOs with GMP certification have the capability to manufacture complex peptide APIs. However, due diligence regarding regulatory compliance, quality standards, and capacity is essential.

4. What are the key risks associated with sourcing plecanatide API?
Risks include supply disruptions due to capacity constraints, geopolitical factors, regulatory non-compliance, and quality deviations. Strategic dual sourcing and rigorous qualification processes mitigate these risks.

5. How might technological progress impact plecanatide API sourcing?
Advances such as automated peptide synthesis and continuous flow chemistry could enhance manufacturing efficiency, reduce costs, and broaden supplier options, improving supply security in the future.

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References

1. U.S. Food and Drug Administration. (2017). FDA approves first drug for irritable bowel syndrome with constipation in pediatric patients. Link
2. Bachem. (2023). Peptide API manufacturing services. Website
3. CordenPharma. (2022). Peptide manufacturing capabilities. Website
4. Patheon (Thermo Fisher Scientific). (2023). Peptide synthesis and API production. Website
5. Lonza. (2023). Peptide API manufacturing. Website
6. International Conference on Harmonisation (ICH). (2019). Principles and guidelines for GMP manufacturing.

Note: This synthesis reflects industry trends and available data as of 2023; ongoing developments may influence the specific landscape of API sourcing for plecanatide.