Kern Pharma S.L.

Kern Pharma S.L.

A part of Kern Pharma’s manufacturing plant, located 25 kms from Barcelona in Spain, is dedicated for the manufacture of Active Pharmaceutical Ingredients, mainly for Fentanyl derivatives.

Kleos Pharma is in charge for the promotion worldwide except on Asia for this range of APIs.
As the chemical workshop is using most of the facilities from the manufacturing plant for finished product, it holds high GMP and quality standards.
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 Base 437-38-7 EU GMP EP / USP READY CEP upon request upon request Available
Remifentanil Hydrochloride 132539-07-2 EU GMP in-house READY - upon request on going 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 Q2 2014 Q4 2014 upon request upon request Available
Sufentanil Base 56030-54-7 - upon request   - - - -