Amgen Manufacturing Limited LLC (tên cũ: Amgen Manufacturing Limited)
USA
18
Total Certificates
1
Valid
5
Facilities
GMP Types
U.S. cGMP (tương đương EU-GMP)
Carr 31 Km 24.6, Juncos, Puerto Rico (PR), 00777, USA (* Cách ghi khác: 24.6 Carr 31, Juncos, PR 00777, USA hoặc State Road 31 Km 24.6, Juncos, Puerto Rico, 00777, USA hoặc Road 31 Km. 24.6 Juncos, Puerto Rico 00777, USA hoặc State Road 31 Kilometer 24.6 Juncos, Puerto Rico 00777, USA)
| GMP Type | Certificate No. | Issuing Authority | Expiry Date | Status |
|---|---|---|---|---|
| U.S. cGMP (tương đương EU-GMP) |
FEI: 1000110364; EI end: 05-07-2023
|
United States Food and Drug Administration (U.S. FDA) | 31/12/2026 | Valid |
| U.S. cGMP (tương đương EU-GMP) |
FEI: 1000110364;
EI end: 05-07-2023
|
United States Food and Drug Administration (U.S. FDA) | 31/12/2025 | Expired |
State Road 31 KM 24.6, Juncos, Puerto Rico, 00777, USA
| GMP Type | Certificate No. | Issuing Authority | Expiry Date | Status |
|---|---|---|---|---|
| U.S. cGMP (tương đương EU-GMP) |
DQP6-CBCZ
|
United States Food and Drug Administration (U.S. FDA) | 28/06/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
7KBB-FR7R
|
United States Food and Drug Administration (U.S. FDA) | 22/06/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
TARA-WMJP;
4ZMB-VPPG;
XXUM-J4YJ
|
United States Food and Drug Administration (U.S. FDA) | 24/02/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
ESWJ-TQEX
|
United States Food and Drug Administration (U.S. FDA) | 31/12/2022 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
HU4R-HXDE
|
United States Food and Drug Administration (U.S. FDA) | 08/04/2022 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
PCJS-PXH4;
CEA8-AYMJ
|
United States Food and Drug Administration (U.S. FDA) | 20/01/2022 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
XSN3-A474;
KKCW-QC26
|
United States Food and Drug Administration (U.S. FDA) | 31/10/2021 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
P83M-ZYCV;
UMGQ-XUU8;
STJN-7NZG
|
United States Food and Drug Administration (U.S. FDA) | 07/05/2021 | Expired |
State Road 31, Kilometer 24.6, Juncos, Puerto Rico, 00777, USA
| GMP Type | Certificate No. | Issuing Authority | Expiry Date | Status |
|---|---|---|---|---|
| U.S. cGMP (tương đương EU-GMP) |
H8EA-WWQ5
|
United States Food and Drug Administration (U.S. FDA) | 02/06/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
HD3G-MWCD
|
United States Food and Drug Administration (U.S. FDA) | 01/03/2022 | Expired |
Road 31 Km. 24.6, Juncos, Puerto Rico, 00777, USA
| GMP Type | Certificate No. | Issuing Authority | Expiry Date | Status |
|---|---|---|---|---|
| U.S. cGMP (tương đương EU-GMP) |
NF6Q-Z54P
|
United States Food and Drug Administration (U.S. FDA) | 26/05/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
GCTR-F4NU
|
United States Food and Drug Administration (U.S. FDA) | 26/04/2022 | Expired |
State Road 31 Km 24.6, Juncos, Puerto Rico, 00777, USA (* Cách ghi khác: State Road 31 Km 24.6, Juncos, Puerto Rico, 00777-4060, USA)
| GMP Type | Certificate No. | Issuing Authority | Expiry Date | Status |
|---|---|---|---|---|
| U.S. cGMP (tương đương EU-GMP) |
JHWA-4GVM;
V45V-D96H
|
United States Food and Drug Administration (U.S. FDA) | 11/04/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
4JYS-MDQ8;
UP72-JKCY
|
United States Food and Drug Administration (U.S. FDA) | 11/04/2023 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
5BFY-N5DF;
QFHE-SD2B
|
United States Food and Drug Administration (U.S. FDA) | 02/08/2022 | Expired |
| U.S. cGMP (tương đương EU-GMP) |
QRHM-KAK2;
TYQJ-3Q39
|
United States Food and Drug Administration (U.S. FDA) | 29/09/2021 | Expired |