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25-30 April, 2025
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27-30 April, 2025
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage
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[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2024-merck-s-keytruda-maintains-top-spot-as-novo-s-semaglutide-nips-at-its-heels
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2020-08-06
Registration Number : No. 695-3-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 : 2025-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2019-06-25
Registration Number : No. 695-1-ND
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 00
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 2422
Status : Valid
NDC Package Code : 62227-026
Start Marketing Date : 2024-04-24
End Marketing Date : 2025-12-31
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-12-22
Registration Number : No. 695-5-ND(3)
Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd.@BrightGene Fine Chemical Co., Ltd.
Manufacturer Address : No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China@No. 10 Tongyuan Road, Taixing Economic Development Zone, Taizhou, Jiangsu 225400, 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 : 62227-003
Start Marketing Date : 2014-03-12
End Marketing Date : 2025-12-31
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 : 2016-03-03
Pay. Date : 2016-01-21
DMF Number : 30090
Submission : 2015-12-30
Status : Active
Type : II
NDC Package Code : 62227-024
Start Marketing Date : 2022-08-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-09-14
DMF Number : 35874
Submission : 2021-04-30
Status : Active
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
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
BrightGene Bio-Medical Technology Co.,Ltd
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FD...
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
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
RLD : No
TE Code : AP
BrightGene Bio-Medical Technology Co.,Ltd
Dosage Form : INJECTABLE; SUBCUTANEOUS
Proprietary Name : FONDAPARINUX SODIUM
Dosage Strength : 2.5MG/0.5ML
Approval Date : 2024-12-18
Application Number : 218312
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-09-10
BrightGene Bio-Medical Technology Co.,Ltd
City : Suzhou
State :
Country/Area : CN
Zip :
District : ORA
Center : CVM
Project Area : Monitoring of Marketed Animal Dr...
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-09-10
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-14
BrightGene Bio-Medical Technology Co.,Ltd
City : Suzhou
State :
Country/Area : CN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-14
BrightGene Bio-Medical Technology Co.,Ltd
Type : GMP Certificates
Number : ZVA/LV/2015...
EudraGMDP Key : 33946
Country : China
Issue Date : 2015-06-05
Post Code : 225401
NCA Ref : 339461434105...
City : Taixing, Taizhou
BrightGene Bio-Medical Technology Co.,Ltd
Type : GMP Certificates
Number : ZVA/LV/2015...
EudraGMDP Key : 33994
Country : China
Issue Date : 2015-06-05
Post Code : 215123
NCA Ref : 339941434106...
City : Suzhou
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : BrightGene Fine Chemical Co., ...
Business Address : No.22 Binjiang South Road, T...
FEI Number : 3011254184
Country : China
Paid in : 2019
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : BrightGene Pharmaceutical Co.,...
Business Address : No. 218 Xinghu Road, Suzhou ...
FEI Number : 3009867839
Country : China
Paid in : 2019
ABOUT THIS PAGE
BrightGene Bio-Medical Technology Co.,Ltd is a supplier offers 70 products (APIs, Excipients or Intermediates).
Find a price of Entecavir bulk with DMF, CEP, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Everolimus bulk with DMF, CEP, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Argatroban bulk with DMF, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Eribulin bulk with DMF, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Micafungin bulk with DMF, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Oseltamivir Phosphate bulk with DMF, CEP offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Sugammadex Sodium bulk with DMF, JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Anidulafungin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Ansamitocin P3 bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Argatroban bulk with JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Carboprost Tromethamine bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of CAS 184177-83-1 bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of CAS 361440-67-7 bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of CAS-149809-43-8 bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Caspofungin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Dalbavancin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Entecavir Intermediate VIII Isomer bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Everolimus bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Exatecan bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Ferric Carboxymaltose bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Fidaxomicin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Fondaparinux Sodium bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Hydroxy Echinocandin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Isavuconazonium Sulfate bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Lurbinectedin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Maytansinoid DM1 bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Micafungin bulk with JDMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Midostaurin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Molnupiravir bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Obeticholic Acid bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Pemetrexed bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Pimecrolimus bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Posaconazole bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Saxagliptin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Sirolimus bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Spinosyn D bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Trabectedin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Trientine Hydrochloride bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Voclosporin bulk with DMF offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Staurosporine bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Amphotericin B bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Apalutamide bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Cabergoline bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Caspofungin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Dienogest bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Doramectin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Dydrogesterone bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Eldecalcitol bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Emodepside bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Entecavir Monohydrate bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Ferric Pyrophosphate Citrate bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Fluralaner bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Gadobutrol bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Ibrexafungerp Citrate bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Iodixanol bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Iomeprol bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Iopromide bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Iron Sucrose bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Josamycin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Laninamivir Octanoate bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Mycophenolate Sodium bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Nicergoline bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Nystatin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Omadacycline bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Oritavancin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Regadenoson Monohydrate bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Relugolix bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Selamectin bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Sugammadex Sodium bulk offered by BrightGene Bio-Medical Technology Co.,Ltd
Find a price of Tacrolimus bulk offered by BrightGene Bio-Medical Technology Co.,Ltd