PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novel Labs Inc	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	202217	ANDA	Lupin Pharmaceuticals, Inc.	43386-071-83	1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)	2015-04-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

The pharmaceutical industry relies heavily on a complex supply chain for raw materials essential to drug manufacturing. Components such as PEG-3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl serve as active ingredients or excipients across various medications, notably in laxatives, electrolyte solutions, and adjunct therapies. Ensuring diversified and reliable sourcing of these substances is critical for manufacturing continuity, regulatory compliance, and cost management.

This overview examines the key global suppliers for each compound, factors influencing supplier choices, and market dynamics impacting procurement decisions.

PEG-3350: Polyethelene Glycol (Molecular Weight 3350)

Overview:
PEG-3350 functions primarily as a laxative agent and in bowel preparation formulations. Its synthesis involves complex polymerization processes, necessitating high-quality manufacturing standards to meet pharmaceutical specifications.

Major Suppliers:

BASF SE: A leading global chemical company providing PEG-3350 for pharmaceutical applications, with ISO-certified manufacturing facilities in Europe and North America.
Lotte Chemical Corporation: Offers pharmaceutical-grade PEG-3350, emphasizing purity and scalability.
Dow Chemical (DowDuPont): Supplies specialty polyethylene glycol derivatives, including PEG-3350, with rigorous quality controls.
Sipen Pharmaceutical (India): A regional player supplying PEG-3350, increasingly important for emerging markets.
Samyang Corporation: South Korea-based, offering PEG-3350 conforming to pharmacopeial standards.

Selection Factors:

Regulatory compliance (FDA, EMA approvals)
Consistency in molecular weight and purity
Manufacturing capacity and lead time
Cost competitiveness

Sodium Chloride

Overview:
Sodium chloride's pharmaceutical applications include saline solutions, electrolyte replenishment, and as an excipient. Its simplicity belies the importance of purity and consistent delivery.

Major Suppliers:

AkzoNobel (formerly ICI): A global leader providing pharmaceutical-grade sodium chloride, emphasizing high purity and low endotoxin levels.
BASF SE: Offers high-quality sodium chloride suitable for injectable solutions.
Cargill, Inc.: Supplies food-grade and pharmaceutical-grade sodium chloride, with extensive North American manufacturing capacity.
Wilmar International: Asian supplier with significant production facilities ensuring competitive pricing.
Nihon Shokuhin Kako Co., Ltd.: Focuses on high-purity salts for pharmaceutical and medical uses.

Selection Factors:

GMP certification and production standards
Endotoxin levels and impurity specifications
Supply reliability and packaging options

Sodium Bicarbonate

Overview:
Used to correct acid-base imbalances and as a component in dialysis solutions, sodium bicarbonate must meet stringent pharmaceutical quality criteria.

Major Suppliers:

Fresenius Kabi: Supplies pharmaceutical-grade sodium bicarbonate, supported by a robust manufacturing network.
BASF SE: Offers high-purity sodium bicarbonate for medical applications.
PQ Corporation: Specializes in specialty bicarbonates for pharmaceutical and industrial purposes.
Nippon Soda Co., Ltd.: Provides high-quality sodium bicarbonate with global distribution capabilities.
Shandong Haike Chemical Co., Ltd.: Growing Chinese supplier offering competitive products in the Asian market.

Selection Factors:

Pharmaceutical-grade certification (BP, USP equivalents)
Price and supply chain stability
Environmental and sustainable practices

Potassium Chloride

Overview:
An essential electrolyte used in infusion therapies, IV fluids, and oral medications, potassium chloride demands purity and precise dosing.

Major Suppliers:

AkzoNobel (now part of Nouryon): Leading provider of pharmaceutical-grade potassium chloride.
Cargill, Inc.: Supplies consistent, high-quality potassium chloride suitable for medical use.
Mitsui & Co.: Japanese conglomerate with extensive chemical manufacturing for pharmaceuticals.
Shandong Jiejing Group: A Chinese manufacturer with a growing presence in global markets.
K+S Aktiengesellschaft: German-based, known for specialty chemicals and pharmaceutical-grade potassium chloride.

Selection Factors:

Purity levels and absence of heavy metals
Formulation options (powder, solutions)
Compliance with pharmacopeial standards

Bisacodyl

Overview:
Bisacodyl acts as a stimulant laxative, available in oral and suppository forms. As an active pharmaceutical ingredient (API), sourcing depends on manufacturing facility approvals and compliance.

Major Suppliers:

Perrigo Company: A significant API manufacturer compliant with GMP standards for bisacodyl.
Fitzgerald Industries International: Offers high-quality bisacodyl complying with global pharmacopeias.
EPM (Eagle Pharmaceutical): Engages in the synthesis and supply of bisacodyl with a focus on pharmaceutical-grade APIs.
Xian Sinuo Pharmaceutical Co., Ltd.: Chinese supplier expanding into Western markets, offering competitive API options.
Zhejiang Haizhu Pharmaceutical Co., Ltd.: A regional supplier with growing international presence.

Selection Factors:

API purity and consistency
Regulatory approvals and manufacturing certifications
Capacity to meet bulk demand

Market Dynamics and Procurement Considerations

Geographical Diversity:
Global sourcing mitigates risks associated with geopolitical issues, supply chain disruptions, and regional shortages. Regional suppliers in India, China, and Southeast Asia are increasingly vital as demand rises.

Regulatory and Quality Standards:
Suppliers must comply with Good Manufacturing Practices (GMP) and meet the standards of regulatory authorities (FDA, EMA, etc.). Certificates of analysis, batch consistency, and traceability are key evaluation criteria.

Cost and Lead Times:
While quality remains paramount, competitive pricing influences supplier selection, especially amidst fluctuating raw material costs and logistics expenses.

Innovation and Sustainability:
Suppliers investing in sustainable manufacturing processes and newer, more efficient production technologies are gaining preference, aligning with corporate social responsibility (CSR) and environmental standards.

Conclusion

The procurement of pharmaceutical-grade PEG-3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl involves engaging with a diverse set of global suppliers. Industry leaders like BASF, Cargill, and AkzoNobel dominate key segments, supported by regional manufacturers from Asia and emerging markets. Procurement strategies must balance quality, supply reliability, regulatory compliance, and cost to ensure seamless manufacturing operations.

Key Takeaways

Diversify sources: Engaging multiple suppliers across regions mitigates supply chain risks, especially for critical API components.
Prioritize quality compliance: GMP certification and adherence to pharmacopeial standards are non-negotiable for pharmaceutical ingredients.
Leverage regional manufacturing: Asian suppliers are increasingly competitive and can offer cost-effective options without compromising quality.
Monitor market trends: Fluctuations in raw material availability and global regulations impact supply chain stability.
Invest in sustainable sourcing: Suppliers with robust environmental practices align with corporate responsibility and can offer long-term benefits.

FAQs

Q1: How can I verify the regulatory compliance of a supplier for pharmaceutical ingredients?
A1: Verify GMP certifications, inspect Certificates of Analysis (CoA), and ensure suppliers hold recognized approvals (FDA, EMA, ISO standards). Audits and third-party assessments further affirm compliance.

Q2: What are the main considerations when choosing suppliers for PEG-3350?
A2: Focus on purity standards, manufacturing capacity, regulatory approvals, price, and lead times.

Q3: Are regional suppliers suitable for global pharmaceutical manufacturing?
A3: Yes, regional suppliers can supplement global sourcing, offering cost benefits and supply flexibility, provided they meet international quality standards.

Q4: What factors influence the pricing of pharmaceutical salts like sodium chloride and potassium chloride?
A4: Raw material costs, production scale, regional labor and energy costs, and logistics influence pricing.

Q5: How does market demand affect bisacodyl API availability?
A5: Increased demand can strain supply, impacting pricing and lead times. Diversified sourcing and maintaining inventory buffers help manage supply continuity.

References

[1] "Global Chemical Suppliers of Pharmaceutical Ingredients," PharmaMarket Research Reports, 2023.
[2] "Market Intelligence on Pharmaceutical Raw Materials," IQVIA, 2022.
[3] "Regulatory Standards for Pharmaceutical Ingredients," U.S. FDA, 2023.
[4] "Sourcing Strategies in Pharmaceutical Manufacturing," Deloitte Insights, 2021.
[5] "Asia’s Growing Role in Pharmaceutical Raw Material Supply," McKinsey & Company, 2022.

Suppliers and packagers for PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL