01 1BrightGene Bio-Medical Technology Co.,Ltd
02 1Brother Enterprises Holding
03 1Divis Laboratories
04 1GE Healthcare Inc
05 1Hengdian Group
06 1Hetero Drugs
07 1IMAX DIAGNOSTIC IMAGING HOLDING LIMITED HK Hong Kong
08 1Jiangsu Hengrui Medicine
09 1Jiangsu Yutian Pharmaceutical Co., Ltd
10 1Sichuan Renan Pharmaceutical
11 1Zhejiang Starry Pharmaceutical Co., Ltd
01 7China
02 2India
03 1Ireland
04 1United Kingdom
01 3Active
02 1Inactive
03 7Blank
01 3Valid
02 8Blank
01 1217MF10958
02 10Blank
01 11Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39261
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-14
Pay. Date : 2016-12-30
DMF Number : 31200
Submission : 2017-01-11
Status : Active
Type : II
NDC Package Code : 57884-0029
Start Marketing Date : 2017-01-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Palm East Co., Ltd.
Registration Date : 2024-07-08
Registration Number : 20210927-210-J-1110(1)
Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Manufacturer Address : Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-15
Pay. Date : 2022-07-27
DMF Number : 36468
Submission : 2022-01-14
Status : Active
Type : II
Certificate Number : R0-CEP 2022-027 - Rev 00
Issue Date : 2023-06-20
Type : Chemical
Substance Number : 2215
Status : Valid
Registrant Name : Essel Bio Co., Ltd.
Registration Date : 2022-02-15
Registration Number : 20220215-210-J-1233
Manufacturer Name : Zhejiang Starry Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Starry Road of Xianju Modern Industrial Centralization Zone, Xianju, Zhejiang, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27478
Submission : 2013-08-28
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-497 - Rev 00
Issue Date : 2023-04-20
Type : Chemical
Substance Number : 2215
Status : Valid
Certificate Number : R0-CEP 2020-410 - Rev 00
Issue Date : 2022-06-22
Type : Chemical
Substance Number : 2215
Status : Valid
Registration Number : 217MF10958
Registrant's Address : Lindesnesveien 208, 4521 Lindesnes, Norway
Initial Date of Registration : 2005-11-14
Latest Date of Registration : --
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