Kern Pharma S.L.
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Part of Kern Pharma’s production site, located 25 km from Barcelona in Spain, is dedicated to the manufacture of active pharmaceutical ingredients, mainly for Fentanyl derivatives. This production facility complies with high quality and GMP standards.
Kleos Pharma is in charge for the promotion worldwide except on Asia for this range of APIs. With customers in more than 20 countries on 5 continents, Kern Pharma can provide a strong and efficient regulatory support. In addition, we can also provide in-house micronization of our Fentanyl derivatives.
Please find below the main APIs offered:
Chemical Name | Salt | CAS Number | GMP | Specifications | ASMF eCTD | CEP | US DMF | JP DMF | Commercial Sale |
---|---|---|---|---|---|---|---|---|---|
Fentanyl | Citrate | 990-73-8 | EU GMP | EP/USP/JP | READY | CEP | READY | READY | Available |
Fentanyl | Citrate micronized | 990-73-8 | EU GMP | EP/USP/JP | READY | N/A | READY | READY | Available |
Fentanyl | Base | 437-38-7 | EU GMP | EP / USP | READY | CEP | upon request | upon request | Will be evaluated if requested |
Remifentanil | Hydrochloride | 132539-07-2 | EU GMP | EP | READY | CEP | upon request | READY | Available |
Sufentanil | Citrate | 60561-17-3 | EU GMP | EP / USP | READY | CEP | upon request | upon request | Available |
Alfentanil | Hydrochloride | 69049-06-5 | EU GMP | EP / USP | READY | CEP | upon request | upon request | Will be evaluated if requested |