Swissmedic licence
Novartis Pharma Stein AG Novartis Technical Operations Schweiz Stein Cell and Gene Therapy
Swissmedic licence 511177-102761487 · Stein · COMPLIANT
Key facts
| Authorization number | 511177-102761487 |
|---|---|
| Licence holder | Novartis Pharma Stein AG |
| Site | Novartis Pharma Stein AG Novartis Technical Operations Schweiz Stein Cell and Gene Therapy |
| City | Stein |
| Canton | AG |
| Country | Switzerland |
| Compliance status | COMPLIANT |
| Last inspection | Jan 17, 2024 |
| Valid until | Indefinite |
| Manufacturing activities | 1 MANUFACTURE OF TpP / GT / GMO, 1.3.1.4 Manufacture of gene therapy products, ST.1.3.1.4.2 Manufacture of ready-to-use ex vivo gene therapy products, ST.1.3.1.4.2.1 intended for autologous transplantation (H/V,I), 1.5 Packaging of TpP / GT / GMO products, 1.5.2 Secondary packing (H/V,I), 1.6 Quality control testing, 1.6.1 Microbiological: sterility (H/V,I), 1.6.2 Microbiological: non-sterility (H/V,I), 1.6.3 Chemical/Physical (H/V,I), 1.6.4 Biological (H/V,I) |
| Wholesale activities | ST.4 wholesale distribution OF TpP / GT / GMO, ST.4.3 wholesale distribution of ready-to-use transplant products, ST.4.3.1 including market release (H/V,I), ST.4.3.5 wholesale distribution of ex vivo gene therapy products, ST.4.3.5.1 intended for autologous transplantation (H/V,I) |
| Import activities | ST.2 IMPORT OF TpP / GT / GMO, ST.2.1 Import of non-ready-to-use TpP as starting material for the manufacture of TpP, ST.2.1.1 intended for autologous transplantation (H/V,I), ST.2.2 Import of non-ready-to-use GT/GMO products as starting material for the manufacture of GT/GMO products, ST.2.2.1 Viral vectors (H/V,I) |
| Record type | Transplant Products |
| Swissmedic record | swissgmdp.ch |
At a glance
- No Licence active
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About Swissmedic establishment licences
Swissmedic licenses establishments that manufacture, import, export or distribute medicinal products in Switzerland and records their GMP/GDP compliance status.