plecanatide: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003-01	1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE	2017-02-21
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003-03	1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE	2017-02-21
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003-07	1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE	2017-02-21
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745	NDA	Salix Pharmaceuticals Inc.	65649-003-30	30 TABLET in 1 BOTTLE (65649-003-30)	2017-02-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Plecanatide is an oral peptide drug developed to treat gastrointestinal disorders, primarily chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Marketed under the brand name Trulance by Synergy Pharmaceuticals (later acquired by Bausch Health), plecanatide mimics the endogenous guanylate cyclase-C (GC-C) agonist, enhancing intestinal fluid secretion and motility. As a relatively specialized pharmaceutical, supply chain dynamics play a critical role in ensuring drug availability and affordability. This analysis explores the key suppliers involved in plecanatide's manufacturing, focusing on active pharmaceutical ingredient (API) production, contract manufacturing organizations (CMOs), and raw material sources.

Manufacturing and Supply Chain Overview of Plecanatide

Plecanatide is a synthetic peptide composed of 14 amino acids, structurally similar to uroguanylin, a natural ligand activating GC-C receptors in the intestinal epithelium. Its manufacturing involves complex peptide synthesis processes, high-purity API production, and rigorous quality control protocols.

The supply chain of plecanatide encompasses several tiers:

Raw Material Providers: Suppliers of amino acids and specialized chemical intermediates.
API Manufacturers: Facilities capable of peptide synthesis at commercial scale.
Formulation and Packaging: CMOs responsible for turning API into finished dosage forms.
Distribution Partners: Logistics providers ensuring global access.

While specific supplier details are often proprietary, public patents, regulatory filings, and industry reports shed light on the key players involved in each stage.

Active Pharmaceutical Ingredient (API) Suppliers for Plecanatide

Peptide Synthesis and API Manufacturing

Due to plecanatide’s peptide nature, its API synthesis involves solid-phase peptide synthesis (SPPS), a process demanding specialized technology and strict quality standards. The key API manufacturers are typically:

Contract Development and Manufacturing Organizations (CDMOs):
These entities often produce peptide APIs under confidentiality agreements owing to proprietary processes. Notably, several leading CDMOs in the peptide synthesis space have capabilities aligned with plecanatide's production requirements.
Industrial Peptide Producers:
Few global players specialize solely in peptide manufacturing due to complexity and cost. The primary companies in this arena include:
- Bachem: A Swiss biotech firm known for custom peptide synthesis and APIs. Bachem supplies peptides to various pharmaceutical companies and has advanced GMP manufacturing facilities.
- Cytogam (Cytovance Biologics): A U.S.-based CDMO providing synthetic peptides, including for gastrointestinal therapeutics, with GMP-certified manufacturing.
- Sino Biopharmaceutical: A Chinese biotech specializing in peptide synthesis, catering to domestic and international markets, potentially including plecanatide APIs.
- Boehringer Ingelheim: An established pharma producer with peptide APIs, though specific involvement in plecanatide production has not been publicly confirmed.

It’s important to note that Synergy Pharmaceuticals (now part of Bausch Health) initially developed plecanatide with its own R&D facilities, but later relied on outsourced manufacturing for commercialization.

Potential Raw Material Suppliers

The raw materials for plecanatide synthesis include high-purity amino acids. Major global suppliers of pharmaceutical-grade amino acids include:

Ajinomoto Co.: A leading producer of amino acids with a broad portfolio suitable for peptide synthesis.
Evonik Industries: Supplies specialized amino acids and chemical intermediates used in peptide manufacturing.
Merck KGaA: Offers a variety of amino acids to peptide producers.
Cambridge Isotope Laboratories: Provides isotopically labeled amino acids, sometimes used in trace studies but relevant for API development.

The complexity of sourcing high-quality amino acids directly impacts the stability and efficacy of collected APIs.

Manufacturing Partnerships and Contract Manufacturing Organizations

Synergy Pharmaceuticals’ strategic shift towards outsourcing components of plecanatide’s production underscores reliance on CDMOs. The following are notable organizations in this process:

Bachem: Acts as a primary peptide API supplier, leveraging its extensive GMP manufacturing capabilities to produce plecanatide at commercial scale.
Recipharm: A European CDMO with peptide synthesis expertise, potentially involved in fabrication or formulation stages.
Cobion (formerly Codexis): Focuses on enzyme development and peptide synthesis, though specific involvement with plecanatide remains unconfirmed.

Regulatory and Supply Chain Challenges

The manufacturing of peptides like plecanatide faces notable challenges:

Complexity of Peptide Synthesis: Peptides are sensitive to degradation and require stringent manufacturing controls, limiting supplier options.
Supply Chain Risks: Raw material shortages, contamination risks, and geopolitical factors can disrupt supply lines.
Patent and Confidentiality Barriers: Proprietary synthesis processes restrict full visibility into supplier networks.
Quality Control and Validation: Ensuring GMP compliance across international suppliers adds to logistical and regulatory complexity.

Emerging Trends and Future Outlook

In response to demand surges and supply chain resilience needs:

Diversification of Suppliers: Pharmaceutical companies seek multiple API sources to mitigate risks.
Development of Synthetic Alternatives: Advances in peptide synthesis technology may broaden the supplier base.
Regional Manufacturing Expansion: Asian firms, especially Chinese and Indian CDMOs, are investing heavily in peptide production capacities, potentially expanding plecanatide’s supplier network.
Vertical Integration: Larger pharmaceutical firms may consider bringing API manufacturing in-house to control supply and quality.

Conclusion

The supply chain for plecanatide hinges on specialized peptide synthesis capabilities, predominantly handled by a handful of experienced CDMOs like Bachem and Cytovance. Raw material suppliers such as Ajinomoto and Evonik provide essential amino acids critical for API synthesis. The strategic reliance on these suppliers necessitates diligent risk management to ensure consistent supply, regulatory compliance, and cost control. As the market for GI therapeutics expands, the evolution of peptide manufacturing partnerships will be pivotal in maintaining supply stability for plecanatide.

Key Takeaways

Plecanatide’s API is produced via complex peptide synthesis, predominantly by specialized CDMOs like Bachem and Cytovance.
Raw material providers such as Ajinomoto and Evonik are critical in supplying high-quality amino acids necessary for API manufacturing.
Supply chain resilience depends on diversification, technological advancements, and regional manufacturing growth.
Proprietary manufacturing processes and confidentiality limit transparency into exact suppliers, necessitating industry intelligence.
Strategic partnerships and technological innovation are vital for ensuring reliable plecanatide supply in a competitive GI therapeutics market.

FAQs

1. Who are the primary suppliers of plecanatide’s active pharmaceutical ingredient (API)?
While specific companies' involvement remains proprietary, leading peptide API manufacturers like Bachem and Cytovance are known to produce such complex peptides, likely including plecanatide.

2. What raw materials are used in plecanatide synthesis, and who supplies them?
High-purity amino acids, predominantly supplied by companies like Ajinomoto and Evonik, form the core raw materials for plecanatide’s peptide synthesis.

3. How does supply chain complexity affect plecanatide availability?
The complexity of peptide synthesis and GMP compliance requirements introduces potential risks, including delays, shortages, or increased costs, especially if key suppliers face disruptions.

4. Are there regional differences in plecanatide suppliers?
Asian firms are expanding capabilities in peptide manufacturing, which may diversify and regionalize supply options compared to traditional Western suppliers.

5. What trends are shaping the future of plecanatide’s supply chain?
Technological advances, supplier diversification, regional manufacturing expansion, and vertical integration are pivotal trends aimed at enhancing supply chain robustness.

Sources

[1] Bachem – Corporate Website
[2] Cytovance Biologics – Capabilities Overview
[3] Ajinomoto Co. – Product Portfolio and Capabilities
[4] Evonik Industries – Amino Acid Supply
[5] Synergy Pharmaceuticals / Bausch Health Regulatory Filings

Suppliers and packagers for generic pharmaceutical drug: plecanatide

plecanatide

Suppliers for the Pharmaceutical Drug: Plecanatide