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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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-12-15
Pay. Date : 2017-09-29
DMF Number : 31949
Submission : 2017-08-23
Status : Active
Type : II
Certificate Number : CEP 2018-283 - Rev 01
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2815
Status : Valid
Registration Number : 228MF10118
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2016-06-24
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 32020
Submission : 2017-09-20
Status : Active
Type : II
Certificate Number : CEP 2022-367 - Rev 00
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2918
Status : Valid
Registration Number : 230MF10023
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2018-02-14
Latest Date of Registration :
NDC Package Code : 62227-019
Start Marketing Date : 2020-12-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2020-08-06
Registration Number : Su695-3-ND
Manufacturer Name : BrightGene Pharmaceutical Co. Ltd@[Sirolimus Manufacturer]BrightGene Fine Chemical Co., Ltd
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China@[Sirolimus Manufacturing Plant]No. 22 Binjiang South Road, Taixing Economic Development Zone, Taizhou Jiangsu, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2023-12-22
Latest Date of Registration :
NDC Package Code : 62227-015
Start Marketing Date : 2018-01-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-04-30
Registration Number : 20250430-210-J-1853
Manufacturer Name : BrightGene Pharmaceutical Co.,Ltd.
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-08
Pay. Date : 2020-11-06
DMF Number : 35118
Submission : 2020-10-28
Status : Active
Type : II
Registration Number : 304MF10030
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2022-02-10
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-03
Pay. Date : 2017-04-06
DMF Number : 31449
Submission : 2017-03-03
Status : Active
Type : II
Registration Number : 230MF10169
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2018-12-19
Latest Date of Registration :
NDC Package Code : 62227-005
Start Marketing Date : 2014-07-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Yuhan Corporation
Registration Date : 2025-11-11
Registration Number : Su695-1-ND(1)
Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-07
Pay. Date : 2021-08-27
DMF Number : 35876
Submission : 2021-04-29
Status : Active
Type : II
Certificate Number : CEP 2022-488 - Rev 01
Issue Date : 2025-11-05
Type : Chemical
Substance Number : 2422
Status : Valid
NDC Package Code : 62227-026
Start Marketing Date : 2024-04-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2021-05-18
Registration Number : 20210518-209-J-995
Manufacturer Name : BrightGene Fine Chemical Co., Ltd.
Manufacturer Address : No.22 Binjiang South Road, Taixing Economic Development Zone, Taizhou City, Jiangsu, 225400, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-28
Pay. Date : 2019-07-01
DMF Number : 33904
Submission : 2019-06-06
Status : Active
Type : II
Registration Number : 305MF10018
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2023-02-02
Latest Date of Registration :
NDC Package Code : 62227-016
Start Marketing Date : 2020-02-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-12-22
Registration Number : Su695-5-ND(3)
Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd.
Manufacturer Address : No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China@No.22 Binjiang South Road, Taixing Economic Development Zone, Taizhou City, Jiangsu, 225400, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26257
Submission : 2012-08-12
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-25
Pay. Date : 2014-11-24
DMF Number : 28803
Submission : 2014-11-26
Status : Active
Type : II
NDC Package Code : 62227-027
Start Marketing Date : 2025-06-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-06
Pay. Date : 2016-09-06
DMF Number : 30767
Submission : 2016-07-15
Status : Active
Type : II
NDC Package Code : 62227-006
Start Marketing Date : 2019-02-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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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

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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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

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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

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 72 products (APIs, Excipients or Intermediates).
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