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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20350
Submission : 2007-03-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21138
Submission : 2007-12-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39831
Submission : 2024-05-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39830
Submission : 2024-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-05
Pay. Date : 2023-05-15
DMF Number : 38290
Submission : 2023-05-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25718
Submission : 2012-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38625
Submission : 2023-08-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2024-01-31
DMF Number : 36099
Submission : 2021-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-12-24
DMF Number : 23216
Submission : 2009-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23217
Submission : 2009-10-21
Status : Active
Type : II
CEP/COS
Certificate Numbers : R0-CEP 2008-309 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2010-05-17
Type : Chemical
Substance Number : 1287
CEP/COS
Certificate Numbers : R1-CEP 2010-078 - Rev 00
Status : Valid
Issue Date : 2016-04-22
Type : Chemical
Substance Number : 1673
Certificate Numbers : R0-CEP 2020-153 - Rev 00
Status : Valid
Issue Date : 2022-05-11
Type : Chemical
Substance Number : 1118
CEP/COS
Certificate Numbers : R0-CEP 2019-211 - Rev 00
Status : Valid
Issue Date : 2022-06-03
Type : Chemical
Substance Number : 2583
CEP/COS
Certificate Numbers : R1-CEP 2011-374 - Rev 00
Status : Valid
Issue Date : 2017-12-15
Type : Chemical
Substance Number : 1140
Certificate Numbers : R1-CEP 2011-375 - Rev 02
Status : Valid
Issue Date : 2021-04-08
Type : Chemical
Substance Number : 1653
Certificate Numbers : R1-CEP 2011-376 - Rev 02
Status : Valid
Issue Date : 2021-03-01
Type : Chemical
Substance Number : 1653
CEP/COS
Certificate Numbers : R1-CEP 2012-234 - Rev 00
Status : Valid
Issue Date : 2018-06-15
Type : Chemical
Substance Number : 2269
CEP/COS
Certificate Numbers : R0-CEP 2021-177 - Rev 00
Status : Valid
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 2743
Registration Number : 223MF10040
Registrant's Address : No.1, North Outer Ring Road, Feixian Country, Shndong Province China
Initial Date of Registration : 2011-03-10
Latest Date of Registration : 2011-03-10
JDMF
Registration Number : 228MF10006
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2020-08-05
JDMF
Registration Number : 303MF10148
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2021-09-17
Latest Date of Registration : 2021-09-17
Registration Number : 304MF10119
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2022-08-10
Latest Date of Registration : 2024-04-18
JDMF
Registration Number : 304MF10137
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2022-10-05
Latest Date of Registration : 2022-10-05
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2018-10-08
Registration Number : 20181008-117-G-151-11
Manufacturer Name : Shandong Luoxin Pharmaceutical...
Manufacturer Address : West Side of Yanbin Road, Economic Development Zone, Feixian Linyi, Shandong PR China...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2020-07-03
Registration Number : 20200703-209-J-544
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2012-06-15
Registration Number : 20120615-113-F-67-18
Manufacturer Name : SHANDONG NEW TIME PHARMACEUTIC...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2014-04-10
Registration Number : 20120615-113-F-67-18(3)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2012-10-12
Registration Number : 20120615-113-F-68-17(1)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2012-10-12
Registration Number : 20120615-113-F-67-18(1)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Penmix Co., Ltd.
Registration Date : 2013-01-31
Registration Number : 20120615-113-F-68-17(2)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1 North Outer Ring Road, Feixian County, Shandong Province
Registrant Name : Penmix Co., Ltd.
Registration Date : 2013-01-31
Registration Number : 20120615-113-F-67-18(2)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1 North Outer Ring Road, Feixian County, Shandong Province
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-10-25
Registration Number : 20120615-113-F-68-17(4)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
NDC Package Code : 42677-108
Start Marketing Date : 2020-08-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (.8kg/kg .2kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 42677-105
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PR...
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 42677-101
Start Marketing Date : 2011-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.6kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 42677-102
Start Marketing Date : 2011-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.7kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 42677-119
Start Marketing Date : 2022-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a natio...
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 120MG
Packaging :
Approval Date : 2022-04-29
Application Number : 214115
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 60MG
Packaging :
Approval Date : 2024-02-08
Application Number : 214115
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 30MG
Packaging :
Approval Date : 2024-02-08
Application Number : 214115
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : MILRINONE LACTATE
Dosage Strength : EQ 1MG BASE/ML
Packaging :
Approval Date : 2023-01-23
Application Number : 216373
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : PIPERACILLIN AND TAZOBACT...
Dosage Strength : EQ 36GM BASE/VIAL;EQ 4...
Packaging :
Approval Date : 2023-04-14
Application Number : 217243
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : PIPERACILLIN AND TAZOBACT...
Dosage Strength : EQ 2GM BASE/VIAL;EQ 25...
Packaging :
Approval Date : 2018-08-10
Application Number : 204959
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : PIPERACILLIN AND TAZOBACT...
Dosage Strength : EQ 4GM BASE/VIAL;EQ 50...
Packaging :
Approval Date : 2018-08-10
Application Number : 204959
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : PIPERACILLIN AND TAZOBACT...
Dosage Strength : EQ 3GM BASE/VIAL;EQ 37...
Packaging :
Approval Date : 2018-08-10
Application Number : 204959
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ROCURONIUM BROMIDE
Dosage Strength : 50MG/5ML (10MG/ML)
Packaging :
Approval Date : 2024-07-12
Application Number : 215684
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ROCURONIUM BROMIDE
Dosage Strength : 100MG/10ML (10MG/ML)
Packaging :
Approval Date : 2024-07-12
Application Number : 215684
Regulatory Info : RX
Registration Country : USA
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 120MG
Approval Date : 2022-04-29
Application Number : 214115
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 30MG
Approval Date : 2024-02-08
Application Number : 214115
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 60MG
Approval Date : 2024-02-08
Application Number : 214115
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : MILRINONE LACTATE
Dosage Strength : EQ 1MG BASE/ML
Approval Date : 2023-01-23
Application Number : 216373
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PIPERACILLIN AND TAZOBAC...
Dosage Strength : EQ 2GM BASE/VIAL;EQ 250M...
Approval Date : 2018-08-10
Application Number : 204959
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PIPERACILLIN AND TAZOBAC...
Dosage Strength : EQ 3GM BASE/VIAL;EQ 375M...
Approval Date : 2018-08-10
Application Number : 204959
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PIPERACILLIN AND TAZOBAC...
Dosage Strength : EQ 4GM BASE/VIAL;EQ 500M...
Approval Date : 2018-08-10
Application Number : 204959
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PIPERACILLIN AND TAZOBAC...
Dosage Strength : EQ 36GM BASE/VIAL;EQ 4.5...
Approval Date : 2023-04-14
Application Number : 217243
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ROCURONIUM BROMIDE
Dosage Strength : 50MG/5ML (10MG/ML)
Approval Date : 2024-07-12
Application Number : 215684
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ROCURONIUM BROMIDE
Dosage Strength : 100MG/10ML (10MG/ML)
Approval Date : 2024-07-12
Application Number : 215684
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Inspections and registrations
ABOUT THIS PAGE
Lunan Pharmaceutical is a supplier offers 80 products (APIs, Excipients or Intermediates).
Find a price of Montelukast Sodium bulk with DMF, CEP, JDMF offered by Lunan Pharmaceutical
Find a price of Clavulanic Acid bulk with DMF, CEP offered by Lunan Pharmaceutical
Find a price of Isoflurane bulk with DMF, CEP offered by Lunan Pharmaceutical
Find a price of Mosapride Citrate bulk with DMF, JDMF offered by Lunan Pharmaceutical
Find a price of Tegafur bulk with DMF, JDMF offered by Lunan Pharmaceutical
Find a price of Zoledronic Acid bulk with DMF, CEP offered by Lunan Pharmaceutical
Find a price of Clavulanic Acid bulk with CEP offered by Lunan Pharmaceutical
Find a price of Isosorbide Mononitrate bulk with CEP offered by Lunan Pharmaceutical
Find a price of Sevoflurane bulk with CEP offered by Lunan Pharmaceutical
Find a price of Alfuzosin HCl bulk offered by Lunan Pharmaceutical
Find a price of Bempedoic Acid bulk with DMF offered by Lunan Pharmaceutical
Find a price of Cabazitaxel bulk with DMF offered by Lunan Pharmaceutical
Find a price of Carfilzomib bulk with DMF offered by Lunan Pharmaceutical
Find a price of Clavulanic Acid bulk with DMF offered by Lunan Pharmaceutical
Find a price of Daunorubicin HCl bulk with DMF offered by Lunan Pharmaceutical
Find a price of Elagolix Sodium bulk with DMF offered by Lunan Pharmaceutical
Find a price of Epirubicin Hydrochloride bulk with DMF offered by Lunan Pharmaceutical
Find a price of Esomeprazole Sodium bulk with DMF offered by Lunan Pharmaceutical
Find a price of Gimeracil bulk with DMF offered by Lunan Pharmaceutical
Find a price of Isoflurane bulk with DMF offered by Lunan Pharmaceutical
Find a price of Isosorbide bulk with JDMF offered by Lunan Pharmaceutical
Find a price of Isosorbide Dinitrate bulk with DMF offered by Lunan Pharmaceutical
Find a price of Isosorbide Mononitrate bulk with DMF offered by Lunan Pharmaceutical
Find a price of Ketorolac Trometamol bulk with DMF offered by Lunan Pharmaceutical
Find a price of Miglitol bulk with JDMF offered by Lunan Pharmaceutical
Find a price of Milrinone bulk with DMF offered by Lunan Pharmaceutical
Find a price of Mycophenolate Mofetil bulk with DMF offered by Lunan Pharmaceutical
Find a price of Mycophenolic Acid bulk with DMF offered by Lunan Pharmaceutical
Find a price of Orlistat bulk with DMF offered by Lunan Pharmaceutical
Find a price of Oteracil Potassium bulk with DMF offered by Lunan Pharmaceutical
Find a price of Sevoflurane bulk with DMF offered by Lunan Pharmaceutical
Find a price of Sirolimus bulk with DMF offered by Lunan Pharmaceutical
Find a price of Sitagliptin Phosphate bulk with DMF offered by Lunan Pharmaceutical
Find a price of Tacrolimus bulk with DMF offered by Lunan Pharmaceutical
Find a price of Tadalafil bulk with DMF offered by Lunan Pharmaceutical
Find a price of Zoledronic Acid bulk with DMF offered by Lunan Pharmaceutical
Find a price of Zolpidem Tartrate bulk with DMF offered by Lunan Pharmaceutical
Find a price of 7-Aminodesacetoxycephalosporanic Acid bulk offered by Lunan Pharmaceutical
Find a price of Tacrolimus bulk offered by Lunan Pharmaceutical
Find a price of Zolpidem Tartrate bulk offered by Lunan Pharmaceutical
Find a price of Abiraterone Acetate bulk offered by Lunan Pharmaceutical
Find a price of Aceclofenac bulk offered by Lunan Pharmaceutical
Find a price of Acipimox bulk offered by Lunan Pharmaceutical
Find a price of Afatinib bulk offered by Lunan Pharmaceutical
Find a price of Apixaban bulk offered by Lunan Pharmaceutical
Find a price of Argatroban bulk offered by Lunan Pharmaceutical
Find a price of Atorvastatin bulk offered by Lunan Pharmaceutical
Find a price of Azilsartan bulk offered by Lunan Pharmaceutical
Find a price of Bortezomib bulk offered by Lunan Pharmaceutical
Find a price of Capecitabine bulk offered by Lunan Pharmaceutical
Find a price of Cefditoren Pivoxil bulk offered by Lunan Pharmaceutical
Find a price of Cyclobenzaprine bulk offered by Lunan Pharmaceutical
Find a price of Daptomycin bulk offered by Lunan Pharmaceutical
Find a price of Dasatinib bulk offered by Lunan Pharmaceutical
Find a price of Daunorubicin bulk offered by Lunan Pharmaceutical
Find a price of Decitabine bulk offered by Lunan Pharmaceutical
Find a price of Enoxaparin Sodium bulk offered by Lunan Pharmaceutical
Find a price of Entecavir bulk offered by Lunan Pharmaceutical
Find a price of Etodolac bulk offered by Lunan Pharmaceutical
Find a price of Ezetimibe bulk offered by Lunan Pharmaceutical
Find a price of Faropenem bulk offered by Lunan Pharmaceutical
Find a price of Fasudil bulk offered by Lunan Pharmaceutical
Find a price of Fludarabine Phosphate bulk offered by Lunan Pharmaceutical
Find a price of Fosaprepitant bulk offered by Lunan Pharmaceutical
Find a price of Gefitinib bulk offered by Lunan Pharmaceutical
Find a price of Histamine Dihydrochloride bulk offered by Lunan Pharmaceutical
Find a price of Ibuprofen bulk offered by Lunan Pharmaceutical
Find a price of Imatinib Mesylate bulk offered by Lunan Pharmaceutical
Find a price of Ivabradine Hydrochloride bulk offered by Lunan Pharmaceutical
Find a price of Levoamlodipine bulk offered by Lunan Pharmaceutical
Find a price of Palbociclib bulk offered by Lunan Pharmaceutical
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Find a price of Rosuvastatin Calcium bulk offered by Lunan Pharmaceutical
Find a price of Salmeterol Xinafoate bulk offered by Lunan Pharmaceutical
Find a price of Sodium Monosialotetrahexosylganglioside bulk offered by Lunan Pharmaceutical
Find a price of Tenofovir Disoproxil Fumarate bulk offered by Lunan Pharmaceutical
Find a price of Tolterodine Tartrate bulk offered by Lunan Pharmaceutical
Find a price of Zanamivir bulk offered by Lunan Pharmaceutical
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