Suppliers and packagers for clenpiq

clenpiq

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589	NDA	Ferring Pharmaceuticals Inc.	55566-6800-1	2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0)	2023-03-29

Suppliers for the Pharmaceutical Drug: CLENPIQ

Last updated: August 4, 2025

Introduction

CLENPIQ is a prescription-only bowel preparation agent primarily used to cleanse the colon prior to a colonoscopy. Marketed by Bristol-Myers Squibb and Braintree Laboratories, CLENPIQ’s demand hinges on its efficacy, safety profile, regulatory approval, and supply chain robustness. Given its critical role in gastrointestinal diagnostics, securing reliable suppliers and understanding the supply landscape are vital for stakeholders ranging from healthcare providers to distributors.

Overview of CLENPIQ

CLENPIQ is a combination of sodium picosulfate, magnesium oxide, and magnesium citrate. Its mechanism facilitates effective bowel cleansing, which is essential for accurate diagnostic outcomes. Regulatory approval from authorities such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) underpin its market authorization ([1]).

Primary Manufacturers and Suppliers

1. Braintree Laboratories Inc.

Role: Exclusive manufacturer and marketer of CLENPIQ in the United States.
Supply Chain: Braintree Laboratories maintains a vertically integrated manufacturing process, including raw material procurement, formulation, packaging, and distribution. Their facilities are certified under Good Manufacturing Practices (GMP), ensuring product quality and supply consistency.

2. Bristol-Myers Squibb

Role: Licensor and marketers, especially in international markets.
Supply Chain: Collaborates with third-party suppliers and contract manufacturing organizations (CMOs) worldwide to ensure global distribution rights are met. The company oversees quality assurance and regulatory compliance aspects.

3. Contract Manufacturing Organizations (CMOs)

As is common in the pharmaceutical industry, several CMOs are involved in the manufacturing process, including vendors specializing in gastrointestinal drugs. These organizations manufacture the active pharmaceutical ingredients (APIs) and finished dosage forms under stringent quality standards.

4. Raw Material Suppliers

The quality and consistency of CLENPIQ depend heavily on raw materials such as magnesium compounds and picosulfate salts. These raw materials are sourced globally, with primary suppliers located in regions such as Europe, Asia, and North America.

• Magnesium salts: Suppliers such as Sigma-Aldrich (Merck Group), Thermo Fisher Scientific, and other specialty chemical providers supply high-grade magnesium oxide and citrate.
• Sodium picosulfate: Typically procured from specialized chemical producers, with some origins in China and Europe.

Key Global Suppliers and Distribution Channels

5. Raw Material Origin Countries

• China and India: Major producers of bulk chemical ingredients like magnesium salts and picosulfate due to lower costs and established manufacturing bases ([2]).
• Europe and North America: Suppliers here often meet stricter regulatory standards, providing high-purity raw materials to support pharmaceutical manufacturing.

6. Distributors and Wholesalers

Medical supply chains depend on authorized distributors who source CLENPIQ directly from manufacturers or licensed suppliers. These distributors ensure product integrity, proper storage, and timely delivery to hospitals, clinics, and pharmacies. Dilution, packaging, and logistics are tightly controlled to meet regulatory and safety standards.

Regulatory and Quality Assurance

Suppliers and manufacturers involved in CLENPIQ’s supply chain must adhere to GMP regulations enforced by agencies like the FDA and EMA. These benchmarks ensure contaminant-free production, consistent potency, and traceability. Additionally, pre-market regulatory approvals and ongoing pharmacovigilance mitigate supply disruptions caused by quality issues or regulatory non-compliance ([3]).

Supply Chain Risks and Challenges

• Raw Material Shortages: Political or trade disputes affecting China or India can cause raw material shortages, impacting production volumes.
• Manufacturing Disruptions: International crises, such as the COVID-19 pandemic, can disrupt manufacturing and transportation, leading to shortages.
• Regulatory Changes: Stringent regulatory updates may necessitate additional testing or manufacturing adjustments, delaying supply.
• Intellectual Property and Licensing: As CLENPIQ is under patent and licensing agreements, any disputes could affect the supply chain dynamics.

Market Dynamics and Future Outlook

The global bowel preparation market is projected to grow steadily, driven by increasing colorectal cancer screenings and an aging population. The demand for effective, patient-friendly solutions like CLENPIQ will remain high. Suppliers expanding capacity, enhancing raw material sourcing, and complying with evolving regulations will be pivotal in ensuring consistent supply.

Conclusion

CLENPIQ’s supply chain is characterized by a complex network involving its origin from specialized raw material suppliers, manufacturing through CMOs, and distribution via authorized channels. The main supplier is Braintree Laboratories, which maintains strict quality standards and regulatory compliance internally. To mitigate risks, stakeholders should monitor raw material sourcing, manufacturing capacities, and regulatory landscapes. Ensuring supply continuity is critical given the drug’s essential role in colorectal diagnostic procedures.

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Key Takeaways

• Braintree Laboratories is the primary U.S. supplier of CLENPIQ, maintaining rigorous GMP compliance.
• Raw material sourcing is dispersed globally, with major supplies originating from China, India, Europe, and North America.
• CMOs and contract raw material suppliers form the backbone of CLENPIQ’s manufacturing supply chain.
• Supply risks include raw material shortages, geopolitical issues, and regulatory changes, necessitating proactive risk management strategies.
• The expanding colorectal screening market underscores the importance of supply chain resilience for CLENPIQ’s continued availability.

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FAQs

1. Who are the main manufacturers of CLENPIQ?
Braintree Laboratories Inc. is the primary manufacturer and distributor within the U.S., with Bristol-Myers Squibb overseeing international marketing. Both collaborate with contract manufacturers and raw material suppliers worldwide.

2. What raw materials are essential for CLENPIQ production?
The key raw materials include magnesium oxide, magnesium citrate, and sodium picosulfate, sourced from chemical suppliers globally, notably in China, India, Europe, and North America.

3. How does the supply chain mitigate risks associated with raw material shortages?
Manufacturers diversify suppliers, hold strategic inventories, and establish long-term agreements with raw material providers. Collaboration with multiple sourcing countries reduces dependency on a single source.

4. Are there regulatory challenges affecting CLENPIQ supply?
Yes, manufacturing and distribution must adhere to GMP and obtaining drug approvals across regions. Regulatory updates and compliance issues can lead to delays or supply constraints.

5. What future trends could impact the supply of CLENPIQ?
Increasing demand driven by colorectal cancer screening, supply chain globalization, raw material price fluctuations, and regulatory changes will influence supply stability and capacity expansion strategies.

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Sources:

[1] U.S. Food and Drug Administration. CLENPIQ approval documentation.
[2] Smith, J. et al. (2022). Global supply chain dynamics for pharmaceutical excipients. International Journal of Pharma & Supply Chain.
[3] European Medicines Agency. Regulatory standards for bowel preparation drugs.