Last updated: April 25, 2026
Which manufacturers supply pharmaceutical-grade BISACODYL?
BISACODYL (API) is typically sourced from established API manufacturers that produce standard laxative-grade material used in tablet and suppository products.
Common supplier groups (API manufacturers)
- Reta Pharma (BISACODYL API)
- Zhejiang Jinhua Zaoyang Pharmaceutical (BISACODYL API)
- Hunan Shentong Pharmaceutical (BISACODYL API)
- Luye Pharma (material supply for laxatives category; often via distributors and CMOs)
Which manufacturers supply POLYETHYLENE GLYCOL 3350 (PEG 3350) for pharma use?
POLYETHYLENE GLYCOL 3350 (PEG 3350) is supplied by major specialty chemical and pharmaceutical excipient producers. Supply often comes as pharma-grade or NF/USP-grade excipient, depending on the buyer’s compendial target.
Common supplier groups (excipient and API-adjacent supply)
- BASF (PEG grades including PEG 3350 for pharma excipient use via specialty channels)
- The Dow Chemical Company (Dow) (PEG supply into pharma excipient channels)
- KH Neochem (polyethylene glycol excipients, including mid/high MW grades)
- Miwon (PEG derivative and polymer supply into pharmaceutical excipient supply chains)
Which manufacturers supply POTASSIUM CHLORIDE (KCl) API/pharma-grade?
POTASSIUM CHLORIDE is a high-volume pharmaceutical salt used across oral tablets, effervescent preparations, and electrolyte products. Procurement typically targets USP/NF grade with controlled impurities (heavy metals, sulfate, moisture, insolubles).
Common supplier groups (API and pharma-grade salt)
- ICL Group (pharma-grade KCl supply via specialty channels)
- K+S (potash-derived KCl supply)
- Merck (MilliporeSigma) (KCl for lab and pharmaceutical channels; often used as starting material or for compounding)
- Lokesh Synthetics (pharma-grade inorganic salts supply network)
Which manufacturers supply SODIUM BICARBONATE (NaHCO3) pharmaceutical grade?
SODIUM BICARBONATE is produced as pharma-grade bicarbonate for oral formulations and effervescent products. Buyers typically specify USP/NF grade and limits on carbonate content, heavy metals, and moisture.
Common supplier groups
- Arm & Hammer (Church & Dwight) (pharmaceutical and consumer-grade NaHCO3 supply into regulated channels)
- Armstrong Chemical (bicarbonate salts supply into industrial and pharma supply chains)
- Solvay (bicarbonate and sodium chemistry supply into regulated categories)
- Archean Group (inorganic pharma salt supply networks)
Which manufacturers supply SODIUM CHLORIDE (NaCl) pharmaceutical grade?
SODIUM CHLORIDE is a standard excipient and API-adjacent material for oral and parenteral products. For injectable use, customers typically require high-purity grades and compliance with pharmacopoeial sterility and endotoxin controls where relevant.
Common supplier groups
- K+S (NaCl supply through regulated bulk and specialty channels)
- European Salt Company (salt supply into pharmaceutical markets)
- Merck (MilliporeSigma) (NaCl pharma-grade availability in regulated supply channels)
- AkzoNobel (via chemicals supply chain partners) (salt procurement routes for pharma formulations)
How sourcing typically works for these five materials
Procurement for BISACODYL, PEG 3350, KCl, sodium bicarbonate, and sodium chloride usually follows one of two paths:
1) Direct API/excipient purchase from an API producer or excipient manufacturer, with COAs, DMFs, and audit packages for compliance.
2) Distribution through GxP-qualified distributors/CMOs, where distributors resell pharma-grade product from multiple upstream manufacturers to reduce lead times and standardize documentation.
Material-by-material compliance checkpoints buyers usually enforce
BISACODYL
- Polymorph and assay controls
- Impurity limits (halogenated, related substances, heavy metals)
- GMP documentation package and traceability
PEG 3350
- Molecular weight distribution specification (MW range around 3350)
- Residual ethylene glycol and diethylene glycol limits
- Peroxide and UV stability indicators where required
POTASSIUM CHLORIDE
- Sulfate and heavy metals limits
- Insolubles and moisture/LOI controls
- Particle size where relevant for dissolution performance
SODIUM BICARBONATE
- Carbonate content and assay limits
- Heavy metal limits
- Particle size and bulk density where relevant for tablet behavior
SODIUM CHLORIDE
- Heavy metals, sulfate/iodide limits
- Microbial controls for non-sterile oral use; sterility and endotoxin controls where injectable grade is required
- For parenteral: additional compliance for packaging and traceability
Key Takeaways
- BISACODYL is usually sourced from specialty API manufacturers with strict related-substance control and DMF-ready documentation.
- PEG 3350 is typically procured as a USP/NF excipient-grade polymer from major specialty chemical or excipient suppliers.
- POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM CHLORIDE are high-volume inorganics sourced through GMP-qualified inorganic salt channels where pharmacopoeial impurity specs and traceability dominate purchasing criteria.
- In regulated manufacturing, buyers often reduce risk by using GxP distributors or CMOs even when purchasing standard APIs/excipients.
FAQs
1) Are these materials typically supplied as APIs or excipients?
BISACODYL is an API. PEG 3350 is an excipient. KCl, sodium bicarbonate, and sodium chloride are excipients and can also be used as actives in electrolyte formulations depending on the product.
2) Do suppliers provide compendial grades (USP/NF)?
Yes. PEG 3350, KCl, sodium bicarbonate, and sodium chloride are commonly sold in USP/NF-compliant formats; BISACODYL is typically provided as pharma-grade API with pharmacopoeial and related-substance controls.
3) What documentation matters most for regulated use?
COA for each lot, supplier GMP status, impurity profile (including heavy metals), and traceability. Many buyers also request DMF or CEP where relevant.
4) Is PEG 3350 supply interchangeable across vendors?
Not always. PEG 3350 includes specifications like molecular weight distribution and residual byproducts; vendors may meet the same nominal grade while differing in detailed impurity profiles.
5) Which of these materials is most sensitive to impurity control?
BISACODYL and PEG 3350 are usually more sensitive to detailed impurity and related-substance profiles. The inorganic salts also have impurity limits, but their specifications are generally more standardized by compendial requirements.
References (APA)
[1] BASF. (n.d.). Polyethylene glycol (PEG) product information. BASF.
[2] Church & Dwight. (n.d.). Sodium bicarbonate products and specifications.
[3] Dow. (n.d.). Polyethylene glycol and related polymer product information. Dow.
[4] ICL Group. (n.d.). Potassium chloride supply and products. ICL.
[5] K+S. (n.d.). Salt and potash products, including pharmaceutical supply channels. K+S.
[6] Merck (MilliporeSigma). (n.d.). Sodium chloride, potassium chloride, and related chemical grades. Merck.
[7] Solvay. (n.d.). Sodium bicarbonate and sodium chemistry products. Solvay.
