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WHO-GMP APIs, or World Health Organization Good Manufacturing Practice Active Pharmaceutical Ingredients, are essential components in the production of pharmaceuticals that meet stringent quality standards. These APIs are manufactured under strict regulations to ensure their safety, efficacy, and quality for use in medications. They are typically produced in facilities that comply with international guidelines set forth by the WHO to ensure consistency and reliability in pharmaceutical manufacturing.
| Certification | WHO-GMP certified |
| Purity Level | Typically 95% or higher |
| Form | Powder, liquid, or crystalline |
| Storage Conditions | Cool, dry place, away from light |
| Shelf Life | Generally 2 to 5 years, depending on the API |
When selecting WHO-GMP APIs, buyers should consider the specific requirements of their formulations, including the desired purity levels and the physical form of the API. It is important to specify any necessary documentation, such as certificates of analysis, and to discuss compliance with relevant regulatory standards. Additionally, buyers should indicate the required quantities to ensure that suppliers can meet their production needs.
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It signifies that the API is manufactured following the World Health Organization's Good Manufacturing Practices, ensuring quality and safety.
Request the certificate of analysis and any relevant documentation from the supplier.
The shelf life generally ranges from 2 to 5 years, depending on the specific API.
Many suppliers offer custom formulations, but it's essential to discuss your specific requirements with them.
Typically, WHO-GMP APIs have a purity level of 95% or higher.
Yes, they should be stored in a cool, dry place, away from light to maintain their stability.