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Digital content

25 Mar 2026
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/brightgenes-oral-dual-agonist-sees-8-weight-loss-8-weeks-slice-early-data

23 Jun 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/brightgene-presents-positive-phase-2-data-for-dual-glp-1rgipr-agonist-for-weight-management-and-type-2-diabetes-and-preclinical-data-for-novel-amylin-analog-at-american-diabetes-associations-85th-scientific-sessions-302488874.html

13 Feb 2020
// Jason Mast ENDPTS
https://endpts.com/a-chinese-company-is-already-mass-producing-gileads-experimental-coronavirus-drug/

13 Feb 2020
// Lucy Parsons PMLIVE
http://www.pmlive.com/pharma_news/chinas_brightgene_successfully_copies_gileads_coronavirus_hopeful_remdesivir_1325639

25 Sep 2019
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212126
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33193
Submission : 2018-10-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26257
Submission : 2012-08-12
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33194
Submission : 2018-10-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32010
Submission : 2017-08-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34434
Submission : 2019-12-23
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37422
Submission : 2022-08-31
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2019-12-09
Pay. Date : 2019-09-12
DMF Number : 34091
Submission : 2019-09-29
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35874
Submission : 2021-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2023-01-18
Pay. Date : 2022-12-12
DMF Number : 37186
Submission : 2022-11-24
Status : Active
Type : II

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CEP/COS
BrightGene Bio-Medical Technology Co.,Ltd
Certificate Numbers : CEP 2018-283 - Rev 01
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2815

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BrightGene Bio-Medical Technology Co.,Ltd
Certificate Numbers : CEP 2022-367 - Rev 00
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2918

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CEP/COS
BrightGene Bio-Medical Technology Co.,Ltd
Certificate Numbers : CEP 2022-488 - Rev 01
Status : Valid
Issue Date : 2025-11-05
Type : Chemical
Substance Number : 2422

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 302MF10033
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2020-03-02
Latest Date of Registration : 2021-08-20

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 230MF10028
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2021-03-05

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2023-12-22
Latest Date of Registration : 2023-12-22

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 304MF10018
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2022-01-26
Latest Date of Registration : 2022-01-26

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BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 228MF10118
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2016-06-24
Latest Date of Registration : 2016-06-24

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 304MF10030
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2022-02-10
Latest Date of Registration : 2022-02-10

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 230MF10169
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2018-12-19
Latest Date of Registration : 2021-11-17

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BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 303MF10069
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2021-04-19
Latest Date of Registration : 2021-04-19

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JDMF
BrightGene Bio-Medical Technology Co.,Ltd
Registration Number : 305MF10018
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2023-02-02
Latest Date of Registration : 2023-02-02

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Regulatory Info : RX
Registration Country : USA
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : TABLET;ORAL
Brand Name : ENTECAVIR
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2019-09-25
Application Number : 212126
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : TABLET;ORAL
Brand Name : ENTECAVIR
Dosage Strength : 1MG
Packaging :
Approval Date : 2019-09-25
Application Number : 212126
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : SOLUTION;SUBCUTANEOUS
Brand Name : FONDAPARINUX SODIUM
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5...
Packaging :
Approval Date : 2024-12-18
Application Number : 218312
Regulatory Info : DISCN
Registration Country : USA

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RLD : No
TE Code : AB
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : TABLET; ORAL
Proprietary Name : ENTECAVIR
Dosage Strength : 0.5MG
Approval Date : 2019-09-25
Application Number : 212126
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : TABLET; ORAL
Proprietary Name : ENTECAVIR
Dosage Strength : 1MG
Approval Date : 2019-09-25
Application Number : 212126
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code :
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : FONDAPARINUX SODIUM
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML...
Approval Date : 2024-12-18
Application Number : 218312
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

Inspections and registrations
Country : China
City/Region : Suzhou
Audit Date : Oct-24
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
BrightGene Bio-Medical Technology Co.,Ltd is a supplier offers 73 products (APIs, Excipients or Intermediates).
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