Suppliers and packagers for sutab

sutab

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135	NDA	Braintree Laboratories, Inc.	52268-201-01	2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC	2020-11-10

Suppliers for the Pharmaceutical Drug: Sutab

Last updated: July 27, 2025

Introduction

Sutab, a prescription-only medication designed primarily for bowel preparation prior to colonoscopy, has garnered significant attention within the gastroenterology domain. Its active ingredients are sodium sulfate, magnesium sulfate, potassium chloride, and sodium chloride, which together facilitate effective bowel cleansing. As the demand for Sutab increases, understanding the supply chain and key suppliers involved in its manufacture becomes essential for healthcare providers, investors, and regulatory bodies. This report analyzes the current landscape of Sutab suppliers, emphasizing manufacturing components, raw material sourcing, distribution channels, and strategic partnerships.

Overview of Sutab Manufacturing and Distribution

Sutab is a pharmaceutical product manufactured by innovative pharmaceutical companies specializing in gastrointestinal therapies. Its formulation is composed of complex salts that require high precision in manufacturing. The supply chain includes raw material procurement, formulation, quality testing, packaging, and distribution. The drug’s manufacturing involves multiple stages with rigorous compliance to Good Manufacturing Practices (GMP) governed by FDA regulations.

Key stakeholders include contract manufacturing organizations (CMOs), raw material suppliers, and distribution networks. Given Sutab’s specific formulation, sourcing high-quality, pharmaceutical-grade chemicals is critical to ensuring efficacy, safety, and regulatory compliance.

Primary Raw Material Suppliers

Critical to Sutab’s effectiveness are its active pharmaceutical ingredients (APIs) — primarily sodium sulfate, magnesium sulfate, potassium chloride, and sodium chloride. These salts must meet stringent quality standards, typically supplied by global chemical suppliers.

1. Sodium Sulfate: One of the main components, utilized as an osmotic laxative. Major suppliers include:

   • FMC Corporation: Offers pharmaceutical-grade sodium sulfate decahydrate, sourced globally with extensive GMP compliance.
   • ProChemicals: Supplies high-purity sodium sulfate, with a focus on pharmaceutical applications.

2. Magnesium Sulfate: Known as Epsom salt, used in medical formulations for its osmotic laxative properties. Key suppliers are:

   • Merck KGaA: A global leader in pharmaceutical ingredients, providing pharmaceutical-grade magnesium sulfate.
   • Thermo Fisher Scientific: Supplies high-purity magnesium sulfate for medical use.

3. Potassium Chloride: An essential electrolyte salt used in Sutab formulations.

   • Sigma-Aldrich (part of MilliporeSigma): Offers pharmaceutical-grade potassium chloride conforming to USP standards.
   • VWR International: Supplies high-quality potassium chloride suitable for injectable and oral applications.

4. Sodium Chloride: A standard pharmaceutical excipient.

   • Fresenius Kabi: Provides pharmaceutical-grade sodium chloride solutions and powders.
   • Cayman Chemical: Supplies sodium chloride for research and pharmaceutical use.

Manufacturing Partners and Contract Manufacturers

While the original formulations of Sutab are developed internally or by the originating pharmaceutical firm, many companies outsource manufacturing to CMOs in regions with established pharmaceutical manufacturing infrastructure, such as Europe, North America, and Asia.

• Alvogen: A notable contract manufacturer involved in gastrointestinal products, with GMP-certified facilities.
• Catalent Inc.: Offers formulation development, manufacturing, and packaging services; known for producing oral dosage forms.
• Recipharm: Provides integrated manufacturing services capable of producing complex salts and liquid formulations.

Partnership with such CMOs ensures manufacturing scalability, compliance with regulations, and quality assurance.

Distribution and Supply Chain Dynamics

Sutab’s distribution is managed through a network of pharmacies, hospitals, and specialty clinics. Key distribution channels include:

• Wholesale Distributors: McKesson, Cardinal Health, and AmerisourceBergen, which stock and distribute Sutab to healthcare providers.
• Direct Contracts with Healthcare Providers: Some manufacturers establish direct agreements with hospitals to streamline supply.
• Regional Distributors: Especially important in international markets where local regulations influence supply logistics.

Supply chain resilience hinges on diversified sourcing, geopolitical stability, and contingency planning. During periods of high demand, such as the COVID-19 pandemic, supply bottlenecks for raw chemicals or manufacturing capacity constraints can impact availability.

Regulatory and Certification Standards

Suppliers and manufacturers must conform to strict regulatory standards:

• FDA Compliance: For US markets, APIs and finished products require FDA approval.
• EMA and MHRA: European and UK regulatory bodies mandate compliance for imports.
• GMP Certification: Ensures production quality and consistency.

Suppliers often seek certifications from organizations such as NSF International or ISO to validate quality systems.

Strategic Considerations for Stakeholders

• Supply Chain Security: Diversifying suppliers for critical raw materials mitigates risks of shortages.
• Quality Assurance: Partnering with reputable vendors maintaining high GMP standards is non-negotiable.
• Geographical Risks: Political instability, trade restrictions, and natural disasters can disrupt supply chains; hence, regional sourcing is advantageous.
• Cost Factors: Fluctuations in chemical prices impact overall manufacturing costs and, consequently, pricing strategies.

Emerging Trends and Future Outlook

The pharmaceutical industry is increasingly emphasizing sustainable sourcing, traceability, and advanced formulation techniques. For Sutab, this may translate into:

• Enhanced collaboration with suppliers for supply chain transparency.
• Adoption of more efficient manufacturing technologies to reduce waste and costs.
• Expansion into emerging markets, requiring new regional suppliers and logistics partners.

Furthermore, the ongoing development of biosimilar and generic formulations could influence supplier dynamics and competition within this space.

Key Takeaways

• Critical Raw Material Suppliers: Leading global chemical companies such as FMC Corporation and Merck KGaA supply high-quality salts essential for Sutab's formulation.
• Manufacturing Partnerships: Contract manufacturing organizations with GMP compliance play a pivotal role in scaling production and maintaining quality standards.
• Distribution Networks: A robust network of distributors, including major wholesalers and regional providers, ensures widespread access to Sutab.
• Regulatory Compliance: Suppliers and manufacturers must adhere to strict regulatory standards to maintain product safety and market access.
• Supply Chain Resilience: Diversification and regional sourcing are vital strategies to mitigate risks associated with raw material shortages and geopolitical disruptions.

FAQs

1. Who are the primary raw material suppliers for Sutab?
   Major suppliers include FMC Corporation (sodium sulfate), Merck KGaA (magnesium sulfate), Sigma-Aldrich (potassium chloride), and Fresenius Kabi (sodium chloride).

2. Are there any regional suppliers involved in Sutab’s manufacturing?
   While most critical raw materials are sourced globally, regional suppliers in North America and Europe are often used to meet demand and comply with regional regulations.

3. What role do contract manufacturing organizations play in Sutab’s production?
   CMOs handle formulation, scaling, and packaging, ensuring compliance with GMP standards to maintain product quality and facilitate widespread distribution.

4. How do supply chain disruptions affect Sutab availability?
   Disruptions in raw material supply or manufacturing capacity constraints can lead to shortages, impacting patient access and clinical scheduling.

5. What regulatory standards must Sutab’s suppliers comply with?
   Suppliers and manufacturers must adhere to FDA, EMA, and GMP standards to ensure safety, efficacy, and quality of the medication across markets.

References

[1] U.S. Food and Drug Administration (FDA). "Manufacturing and Quality Control Guidance."
[2] Merck KGaA. "Pharmaceutical Ingredients Portfolio."
[3] Sigma-Aldrich. "High Purity Potassium Chloride."
[4] FMC Corporation. "Chemical Solutions for Pharmaceuticals."
[5] Recipharm. "Contract Manufacturing Services."