GYLDEN PHARMA LIMITED – MIA(IMP) 57419
| Authorisation Number | UK MIA(IMP) 57419 |
| Category | MIA(IMP) |
| Holder | GYLDEN PHARMA LIMITED |
| Registered Address | GYLDEN PHARMA LIMITED, 65 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, UNITED KINGDOM |
| Authorisation Date | Dec 15, 2025 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.1 1.1.1 1.1.1.4 1.2 1.2.1 1.2.1.6 1.5 1.5.1 1.5.1.6 1.6 1.6.3 |
| Importation Operations | 2.2 2.2.1 2.2.1.1 2.2.1.2 2.3 2.3.2 |
| MHRA Link | View on MHRA Website |
Sites (1)
EMERGEX VACCINES HOLDING LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.1 — Aseptically prepared (processing operations for the following dosage forms)
1.1.1.4 — Small volume liquids
1.2 — Non-sterile investigational medicinal products
1.2.1 — Non-Sterile Products (processing operations for the following dosage forms)
1.2.1.6 — Liquids for internal use
1.5 — Packaging
1.5.1 — Primary packaging
1.5.1.6 — Liquids for internal use
1.6 — Quality control testing
1.6.3 — Chemical/Physical
Importation
2.2 — Batch certification of imported medicinal products
2.2.1 — Sterile Products
2.2.1.1 — Aseptically prepared
2.2.1.2 — Terminally sterilised
2.3 — Other Importation Activities
2.3.2 — Importation of Intermediate which undergoes further processing
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