CREMER OLEO is one of the world's largest independent distributors of vegetable glycerine. With locations in Europe, North and South America and Asia, we are very closely networked globally and can supply glycerine in many purity grades and with dedicated certifications.
We are aware of the increasing regulatory requirements that our pharmaceutical and neutraceutical customers have to meet. That is why we offer an EXCiPACT™ certified glycerine in our CREMER Health product range, which meets recognised GMP and GDP standards and can eliminate the need for double audits.
What are the benefits of EXCiPACT™ certification?
EXCiPACT™ is a voluntary, international and independent certification scheme for pharmaceutical excipients. Accounting for an average of more than 90% by volume and weight, excipients often make up the majority of a pharmaceutical product. Excipients determine the shape, colour, odour and taste of pills and coated tablets and can control the release of active ingredients.
EXCiPACT™ certification combines the mandatory quality standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for pharmaceutical excipients with the requirements of the IPEC and ISO 9001 standards. It documents that the minimum GMP and GDP requirements for an excipient have been met. This makes it easier for pharmaceutical manufacturers to evaluate their excipients within their risk matrix. Compliance of manufacturers and/or suppliers within the supply chain can be easily verified, eliminating the need for duplicate audits.
The EXCiPACT™ certificate is recognised by global authorities such as the European Union (EU), the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Authority (MHRA).
Applications for EXCiPACT™ certified Pharmaceutical Glycerine from CREMER OLEO:
Softgel capsules
Glycerine can be used as a plasticizer in soft gel capsules. It makes up about 30% of the liquid that makes up the capsule.
Ear drops
Glycerine is used in ear drops, for example, to soften cerumen. It can also be contained in drops that act against middle ear inflammation.
Eye drops
In eye drops, glycerine serves to keep the eyes moist. It can thus act as protection against irritation and infection, for example.
Ointments
Ointments with glycerine are used to treat or prevent dry, rough, scaly or itchy skin.
Cough syrup
In cough syrup, glycerine is used as an expectorant and lubricant that coats the surface of the throat, reducing cough irritation. The natural sweetness of glycerine can improve the taste of the syrup.
CREMER OLEO's EXCiPACT™ certified glycerine portfolio:
- CremerPHARM EXCiPACT™ certified Glycerine 86,5%
- CremerPHARM EXCiPACT™ certified Glycerine 99,5%
- CremerPHARM EXCiPACT™ certified Glycerine 99,7%
Specifications:
- EP, USP, E422, JP
Form:
- Flüssig
Packaging:
- Loose / bulk in tank truck
- ISO containers
- IBC containers
- Flexi-bags
- Drums
- Cans
Further Certificates:
- Kosher
- Halal
- ISO 50001
- ISO 22000
- ISO 140001
- RSPO MB
Your contact for EXCiPACT™ certified Glycerine at CREMER OLEO
Ruby Pfundstein
Product Manager Glycerine
Phone: +49 40 320 11 336
E-Mail