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

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

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

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

Suppliers for PEG-3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, and Bisacodyl: Contract Manufacturers, Key Distributors, and Sourcing Routes

Last updated: May 17, 2026

Who supplies PEG-3350 (polyethylene glycol 3350) for pharmaceutical use?

PEG-3350 is supplied as pharmaceutical grade polymer excipient used in solid-dose, oral liquid, and laxative formulations (including bowel prep products). Sourcing is typically via excipient majors, specialty PEG manufacturers, or authorized distributors.

What are the main pharmaceutical-grade PEG-3350 supplier categories?

• Polymer/excipient manufacturers that sell PEG grades under regulated specifications.
• Global chemical distributors that stock pharma-grade grades with CoA and traceability.
• Contract manufacturers that can supply PEG as a material input for formulation and packaging, when the supplier is bundled into the service.

Commonly used PEG-3350 sourcing channels

• “Direct to plant” purchasing from excipient manufacturers.
• “Through distributor” purchasing for fill-in supply, regional availability, and shorter lead times.
• “Bundle with CDMO” purchasing for combination projects where the CDMO manages GMP procurement.

Which companies supply pharmaceutical sodium chloride (NaCl) for drug manufacturing?

Sodium chloride is a commodity sterile and non-sterile excipient for injection, oral rehydration systems, and as a formulation component for drug products and medical devices. Suppliers range from global chemical producers to sterile API/excipient suppliers for parenteral use.

What sodium chloride grades are typically sourced?

• Non-sterile USP/NF excipient for tablets/capsules and non-sterile liquids.
• Sterile, for parenteral formulations and device/compounding supply chains.
• Low-endotoxin and purified grades for injectables, depending on the target drug product.

Who supplies sodium bicarbonate (NaHCO3) for pharma formulations?

Sodium bicarbonate is used as a buffering agent, effervescent component, and alkalinizing excipient. Pharmaceutical sourcing is usually specified to pharmacopeial grade (USP/NF or equivalent) and impurity limits.

What are typical pharma-grade sodium bicarbonate purchasing specifications?

• USP/NF or equivalent grades.
• Particle size and bulk density specs for solid dosage manufacturability.
• COA-driven compliance for sodium, chloride, carbonate equilibrium-related impurities depending on intended use.

Which companies supply potassium chloride (KCl) for drug products?

Potassium chloride is used as a electrolyte source and excipient in oral solids and liquids, and as a parenteral component when sterile grade is required. Supply is generally split by sterile vs non-sterile grade.

What potassium chloride procurement constraints apply most often?

• Sterile grade requirements for injectables.
• Halide-related impurity targets and microbial/endotoxin controls for parenteral applications.
• Particle size and flow properties for solid dosage and granulation.

Who supplies bisacodyl (active pharmaceutical ingredient, API) and what supplier pathways exist?

Bisacodyl is an active laxative (a small-molecule API) used in tablets, delayed-release tablets, and suppositories. Unlike excipients, bisacodyl is purchased as API from certified API manufacturers, brokers, or through vertically integrated supply from pharma ingredient producers.

Main supplier pathways for bisacodyl

• Direct API manufacturer supply to pharma or CDMO.
• Through distribution/broker channels with CoA traceability and chain-of-custody documentation.
• CDMO-managed procurement for projects where the manufacturer controls the API sourcing and compliance package.

What is the safest sourcing model for PEG-3350, NaCl, NaHCO3, KCl, and bisacodyl?

For business-critical launches, the lowest execution risk is a supplier strategy that matches grade and intended dosage form:

• Excipient materials (PEG-3350, NaCl, NaHCO3, KCl): ensure the grade matches the intended processing class (sterile vs non-sterile, USP/NF or equivalent, impurity controls, and material handling requirements).
• API (bisacodyl): qualify at least one primary and one secondary API source, with full documentation for GMP supply, CoA, and stability handling.

Supplier mapping for procurement planning: excipients vs API

Material	Typical role	Typical supplier type	Key qualification focus
PEG-3350	Laxative excipient, tablet excipient, osmotic agent	Excipient/polymer manufacturers and distributors	Pharmacopeial grade, molecular weight distribution, impurity limits, CoA traceability
Sodium chloride	Electrolyte/excipient for solutions and oral products	Chemical/pharma excipient suppliers, sterile excipient providers	USP/NF or sterile grade specs, endotoxin/bioburden where relevant
Sodium bicarbonate	Buffer/alkalinizing excipient	Pharmacopeial excipient suppliers	Particle properties, assay, impurities and carbonate balance
Potassium chloride	Electrolyte/excipient	Pharmacopeial excipient suppliers, sterile grade providers	Sterile vs non-sterile grade, chloride and metallic impurities, CoA controls
Bisacodyl	Laxative API	API manufacturers (GMP) and qualified distributors	GMP compliance, polymorph/form specs if applicable, impurity profile, stability

How many supplier options exist per material in regulated supply chains?

• PEG-3350, NaCl, NaHCO3, KCl: multiple global excipient suppliers plus regional distributors with pharmaceutical grade inventory.
• Bisacodyl: fewer GMP API sources than commodity excipients; supply is concentrated among specialized API manufacturers, with additional options via qualified distributors.

What documents are required to onboard suppliers for these materials?

Procurement qualification typically requires:

• GMP certificate or equivalent compliance documentation (for bisacodyl API; and GMP-style compliance for sterile excipients).
• Certificate of Analysis for each lot.
• Quality agreements and change control mechanisms.
• Test method summaries and impurity profiles aligned to the drug product specification.
• Stability data for excipients where storage and shelf life drive risk, and for bisacodyl where stability and impurity drift are critical.

Key Takeaways

• PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride are typically sourced as pharmacopeial excipients from excipient manufacturers and distributors; supply strategy should match sterile vs non-sterile grade requirements.
• Bisacodyl is an API and requires GMP-qualified supply; supplier options are more constrained than for excipients, so dual-source qualification is operationally important.
• Supplier onboarding must be driven by grade-specific specs, lot-level CoA traceability, and documented change control.

FAQs

1) How do I source sterile sodium chloride for injectable formulations?

Procure a sterile, pharmacopeial-grade sodium chloride with explicit endotoxin/bioburden controls and sterile manufacturing documentation aligned to the intended injectable dosage form.

2) What grade of PEG-3350 is needed for bowel prep or laxative tablets?

Use a pharmacopeial PEG-3350 grade with molecular weight distribution and impurity profile that matches the formulation’s specification and dissolution/performance requirements.

3) Can bisacodyl be sourced through a CDMO procurement program?

Yes. CDMOs often manage GMP procurement, but the project typically still requires API quality agreement review, CoA alignment, and change control for any supplier substitution.

4) What testing is most critical for potassium chloride in oral solid dosage forms?

Assay and impurity profiling plus particle/flow-related properties aligned to granulation and blending performance, supported by lot CoA and method validation fit.

5) What documentation differentiates compliant API supply of bisacodyl from gray-market material?

GMP-compliant API manufacturing documentation, a signed quality agreement, and lot-level traceability with impurity profiles consistent with the finished drug’s specification.

References

1. U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. FDA.
2. USP. USP–NF General Chapters and Monographs (PEG-3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, Bisacodyl as applicable). United States Pharmacopeia.