BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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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 6, 2025

Introduction

The pharmaceutical supply chain for active ingredients and excipients is pivotal to the global health industry. Securing reliable suppliers for drugs such as Bisacodyl, Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate, and Sodium Chloride is essential for manufacturers, distributors, and healthcare providers aiming for quality, consistency, and regulatory compliance.

This report examines the primary suppliers of these key pharmaceutical compounds, highlighting their manufacturing footprints, compliance standards, and market positioning to assist industry stakeholders in making strategic sourcing decisions.

Bisacodyl: Suppliers and Market Overview

Bisacodyl is a stimulant laxative widely used for bowel preparation and constipation relief. Its supply landscape primarily involves well-established APIs manufacturers located in Europe, Asia, and North America.

Lupin Ltd. (India): A leading producer of Bisacodyl API, Lupin operates state-of-the-art facilities compliant with GMP standards and supplies to global markets (Lupin Annual Report 2022). Lupin's consistent quality and capacity make it a trusted source.
Mitsubishi Chemical (Japan): With advanced chemical manufacturing processes, Mitsubishi offers high-purity Bisacodyl APIs aligned with strict regulatory requirements, especially for Japanese and Asian markets.
Aenova Group (Germany): While primarily known for finished dosage forms, Aenova sources high-quality Bisacodyl APIs for formulation purposes, reinforcing the importance of European suppliers.
Other Notable Suppliers: Anchem (China), Zhejiang Medicine (China), and Strides Pharma Science (India) also produce BISACODYL API for regional and export use.

Polyethylene Glycol 3350 (PEG 3350): Sources and Key Players

Polyethylene Glycol 3350 is an osmotic laxative and a critical excipient in many pharmaceutical formulations.

BASF SE (Germany): A leading supplier of PEGs, BASF offers high molecular weight PEGs including PEG 3350 adhering to USP standards, with global distribution channels. Their quality assurance and rigorous compliance set a benchmark.
Dow Chemical (USA): A major producer with integrated manufacturing facilities, Dow supplies PEG 3350 for both pharmaceutical and industrial applications.
Lotte Chemical (South Korea): Offers PEG 3350 with high purity and GMP compliance, serving Asian and international markets.
Thermo Fisher Scientific (USA): Supplies PEG 3350 as a pharmaceutical excipient, primarily sourcing from leading manufacturers and ensuring cGMP compliance.
Chinese Manufacturers: Companies like Zhejiang Chenhua Pharmaceutical and Shandong Dongsheng Chemical provide cost-competitive PEG 3350 APIs that meet international standards.

Potassium Chloride (KCl): Supply Chain and Key Suppliers

Potassium Chloride is used both as a supplement and electrolyte replenisher.

Mitsubishi Chemical (Japan): A global leader with extensive KCl production capacity, Mitsubishi ensures high purity and consistent quality.
Qinghai Salt Lake Industry Co., Ltd. (China): One of the largest KCl producers worldwide, offering both pharmaceutical and food-grade KCl, with extensive export credentials.
Potassium Products CO. (Finland): Supplies pharmaceutical-grade KCl, emphasizing purity and compliance with European pharmacopoeia standards.
PotashCorp (Canada): A major potassium producer providing pharmaceutical-grade KCl to global markets.

Sodium Bicarbonate: Leading Suppliers

Sodium Bicarbonate serves multiple roles, from antacid to buffer agent.

Tate & Lyle (UK): A renowned provider of pharmaceutical-grade sodium bicarbonate, adhering to strict GMP and pharmacopoeial standards.
OMK (Russia): Holds significant capacity for producing high-purity sodium bicarbonate for pharmaceutical applications.
JFE Chemical Corporation (Japan): Offers high-grade sodium bicarbonate with reliable quality metrics for formulations requiring precise pH control.
Cairo Sodium Bicarbonate (Egypt): Emerging as a supplier catering to regional markets, with expanding capacity for pharmaceutical-grade sodium bicarbonate.

Sodium Chloride: Major Source Providers

Sodium Chloride is ubiquitous as an excipient, preservative, and saline component.

Hubei Yihua Chemical Industry (China): An established producer of pharmaceutical-grade sodium chloride, complying with USP/EP standards.
Compagnie des Salines de l’Atlantique (France): Supplies high-purity sodium chloride with proven quality in European markets.
Hilmar Cheese Company (USA): Engages in the manufacture of pharmaceutical-grade sodium chloride for various applications.
ICL Group (Israel): Offers a comprehensive portfolio of high-quality sodium chloride, ensuring adherence to global regulatory standards.

Regulatory and Quality Considerations

Suppliers within this landscape must comply with relevant pharmacopoeial standards (USP, EP, JP) and maintain Good Manufacturing Practices (GMP) certification to ensure pharmaceutical-grade quality. Audits, ISO certifications, and quality assurance reports underpin supplier credibility.

Emerging markets, especially China and India, present a robust supplier base with competitive pricing but demand comprehensive due diligence to confirm regulatory compliance and consistent quality.

Market Dynamics and Sourcing Strategies

The supplier landscape reflects a balance between established multinationals and regional manufacturers. Global buyers should consider factors such as lead times, regulatory approvals, pricing, and supplier audits in their procurement strategies.

Strategic sourcing involves diversifying suppliers to mitigate risks associated with geopolitical disruptions, quality variability, or capacity constraints. Collaborating with suppliers with certified manufacturing facilities (GMP, ISO) and extensive export experience is crucial.

Conclusion

A resilient pharmaceutical supply chain for Bisacodyl, PEG 3350, KCl, Sodium Bicarbonate, and Sodium Chloride relies on diversified, compliant, and certified suppliers. Recognizing the key players—ranging from global leaders like BASF and Mitsubishi to regional manufacturers—enables industry participants to optimize procurement, ensure regulatory adherence, and sustain supply continuity.

Key Takeaways

Diversify sourcing across regions and suppliers to minimize risks.
Prioritize suppliers with GMP and pharmacopoeial compliance for quality assurance.
Leverage global suppliers like BASF, Mitsubishi, and Qingshai Salt Lake Industry for high-volume needs.
Conduct rigorous audits and quality checks before onboarding new suppliers.
Monitor regulatory landscapes to ensure ongoing compliance and market access.

FAQs

1. How can I verify the quality and compliance of pharmaceutical raw material suppliers?
Verify suppliers’ certifications such as GMP, ISO, and pharmacopoeial compliance. Conduct on-site audits and review batch quality reports. Engage with third-party testing laboratories for independent verification.

2. What are the key considerations when sourcing Bisacodyl API?
Ensure suppliers meet regulatory standards, have reliable manufacturing capacity, and possess documented quality control procedures aligned with USP or EP standards. Consider logistical factors like lead times and export licenses.

3. Are regional suppliers suitable for large-scale pharmaceutical manufacturing?
Regional suppliers can be suitable if they comply with international standards and carry proper certifications. Balance cost benefits with quality assurance and regulatory acceptance.

4. What are emerging trends in the supply of these pharmaceutical ingredients?
Growing emphasis on sustainable manufacturing, higher regulatory scrutiny in supply chains, and increased capacity from Asian manufacturers are shaping the market dynamics.

5. How does geopolitical stability impact suppliers of these drugs?
Geopolitical issues can disrupt supply chains, especially from regions facing trade restrictions or regulatory changes. Diversification and strategic safety stocks mitigate such risks.

References

[1] Lupin Limited Annual Report, 2022.
[2] BASF SE Corporate Publications, 2022.
[3] Mitsubishi Chemical Corporate Overview, 2022.
[4] European Pharmacopoeia and USP Standards.
[5] Industry Market Reports on Active Pharmaceutical Ingredient Suppliers, 2022.

Suppliers and packagers for generic pharmaceutical drug: BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE