Kolb Distribution Ltd. in Hedingen, Switzerland has been awarded in 2023 an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally recognised Certification Bodies. The Certificate demonstrates that our Swiss site manufactures alkyloxylates (polysorbates, macrogols / PEGs, macrogol lauryl ethers) for use as pharmaceutical excipients according to the 2021 EXCiPACT Certification Standard for Pharmaceutical Excipient Suppliers.
For decades, our products are well established in pharmaceutical formulations as process aids, during purification steps, in diagnostics, and in many biotechnological processes.
Pharmaceutical companies stay with KLK Kolb not only for the unique functionalities our nonionic surfactants provide but also because they know that KLK Kolb will go that extra mile to meet their needs.
Standard excipients can be sourced from various suppliers, but what if you need to customise an excipient to suit your needs?
This is what we do:
The right carrier for your API
An API is useless unless it has the right carrier that can properly solubilise it and make it bioavailable. KLK Kolb’s polysorbates with the brandname Hedisan have a long and successful track record for solubilising and enhancing the API’s in formulations.
We have established one of the highest quality standards in the market according to customer requirements.
Why are polysorbates widely used in the pharmaceutical industry?
- Enhance API stability
- Improve API solubility
- Increase drug bioavailability
- Boost formulation efficacy
Our Products are already included in many products on the market worldwide:
- Animal health formulations
- Eye, ear, and nose drops
- Biotech process additives
- Food supplements
- Blood purification and treatments
- Topical applications
- Tablets & pills
- Wound treatments
Why Hedjuvan, KLK Kolb's pharmaceutical excipients?
AssuredConsistent product composition and high purity
CompleteRequired composition by process and without post treatments
Low riskAll manufacturing steps at one site in Switzerland, GMP EXCiPACT Certified
SmartShort ways, dedicated teams and efficient processes
Quality in processes and products
Every manufacturing step and every quality check is documented in order to secure the production process and product quality of our excipients for our customers in the pharmaceutical industry. A change management process is in place and the access to production and laboratories is restricted only to authorized employees.
Competence in Ethoxylation & Esterification
50 years’ experience in manufacturing Polysorbates, Sorbitan Esters and other non-ionic surfactants such as Macrogols allows us to steer this complex molecular diversity consistently.
Polysorbates, that are ethoxylated sorbitan esters, are widely used in the pharmaceutical industry. The sorbitan esters in polysorbates are also made by KLK Kolb, even at the same location. This is a unique aspect contributing to KLK Kolb’s exemplary proficiency in manufacturing polysorbates and sorbitan esters of high quality for decades and ahead of current market standards for excipients.
Our portfolio includes
|Monograph Title||KLK Kolb product||Grade||Production Standard|
|Polysorbate 20||Hedjuvan-PS20||Tested according to Ph. Eur. / USP / ChP||GMP EXCiPACT|
|Polysorbate 60||Hedjuvan-PS60||Tested according to Ph. Eur.||GMP EXCiPACT|
|Polysorbate 80||Hedjuvan-PS80||Tested according to Ph. Eur. / USP / ChP / JP||GMP EXCiPACT|
|Macrogol 300||Hedjuvan-MG300||Tested according to Ph. Eur. / USP||GMP EXCiPACT|
|Macrogol 400||Hedjuvan-MG400||Tested according to Ph. Eur. / USP||GMP EXCiPACT|
|Macrogol 600||Hedjuvan-MG600||Tested according to Ph. Eur. / USP||GMP EXCiPACT|
|Macrogol 1000||Hedjuvan-MG1000||Tested according to Ph. Eur. / USP||GMP EXCiPACT|
|Macrogol 1500||Hedjuvan-MG1500||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Macrogol 3350||Hedjuvan-MG3350||Tested according to Ph. Eur.||ISO 9001:2015 / IPEC GMP|
|Macrogol 4000||Hedjuvan-MG4000||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Macrogol 6000||Hedjuvan-MG6000||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Sorbitan Monolaurate||Hedjuvan-SE20||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Sorbitan Monostearate||Hedjuvan-SE60||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Sorbitan Monooleate||Hedjuvan-SE80||Tested according to Ph. Eur. / USP||ISO 9001:2015 / IPEC GMP|
|Macrogol Laurylether 9 EO||Hedjuvan-PD9||Tested according to Ph. Eur.||ISO 9001:2015 / IPEC GMP|