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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-25
Pay. Date : 2014-02-28
DMF Number : 13092
Submission : 1998-07-10
Status : Active
Type : II
Certificate Number : R1-CEP 2003-027 - Rev 03
Issue Date : 2015-08-24
Type : Chemical
Substance Number : 267
Status : Valid
Registration Number : 301MF10007
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2019-05-27
Latest Date of Registration :
NDC Package Code : 58624-0302
Start Marketing Date : 1987-01-01
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 : 2018-04-20
Pay. Date : 2017-12-04
DMF Number : 27430
Submission : 2013-07-23
Status : Active
Type : II
Certificate Number : R1-CEP 2016-052 - Rev 00
Issue Date : 2022-04-20
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 227MF10242
Registrant's Address : No. 14, Dongyi Road, Zhangdian Zibo, Shandong, P. R. China
Initial Date of Registration : 2015-10-07
Latest Date of Registration :
NDC Package Code : 58624-0621
Start Marketing Date : 1984-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-03-05
Registration Number : 20250305-211-J-1798
Manufacturer Name : Shandong Xinhua Pharmaceutical Co.,Ltd
Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, PR 255075. China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-02
Pay. Date : 2018-09-28
DMF Number : 22598
Submission : 2009-03-05
Status : Active
Type : II
Certificate Number : R1-CEP 2009-174 - Rev 02
Issue Date : 2022-04-11
Type : Chemical
Substance Number : 38
Status : Valid
Registration Number : 221MF10029
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2009-02-09
Latest Date of Registration :
NDC Package Code : 58624-0234
Start Marketing Date : 2000-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Roche Korea Co., Ltd.
Registration Date : 2023-03-21
Registration Number : 20210810-209-J-943(1)
Manufacturer Name : Shandong Xinhua Pharmaceutical Co., Ltd
Manufacturer Address : East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong, PRChina 255075
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4633
Submission : 1982-07-28
Status : Active
Type : II
Certificate Number : CEP 1998-004 - Rev 08
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 299
Status : Valid
Registration Number : 217MF10482
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2005-09-06
Latest Date of Registration :
NDC Package Code : 58624-0401
Start Marketing Date : 1998-08-01
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 : 2017-02-01
Pay. Date : 2017-01-03
DMF Number : 10730
Submission : 1994-01-20
Status : Active
Type : II
Certificate Number : R1-CEP 2001-210 - Rev 05
Issue Date : 2016-11-14
Type : Chemical
Substance Number : 309
Status : Valid
NDC Package Code : 58624-0452
Start Marketing Date : 1985-01-01
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 32319
Submission : 2017-11-22
Status : Active
Type : II
Registration Number : 303MF10169
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2021-11-25
Latest Date of Registration :
NDC Package Code : 58624-0708
Start Marketing Date : 2024-05-09
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 : 2021-12-10
Pay. Date : 2021-05-21
DMF Number : 34361
Submission : 2020-03-10
Status : Active
Type : II
Registration Number : 305MF10044
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2023-04-05
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31035
Submission : 2016-10-19
Status : Active
Type : II
Certificate Number : R1-CEP 2001-356 - Rev 04
Issue Date : 2017-08-11
Type : Chemical
Substance Number : 1346
Status : Valid
NDC Package Code : 58624-0707
Start Marketing Date : 2024-03-28
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 27827
Submission : 2013-12-01
Status : Active
Type : II
Certificate Number : CEP 2017-269 - Rev 01
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 201
Status : Valid
NDC Package Code : 58624-0520
Start Marketing Date : 1997-01-01
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 35461
Submission : 2020-12-22
Status : Active
Type : II
Certificate Number : CEP 2022-349 - Rev 00
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 354
Status : Valid
Inspections and registrations
ABOUT THIS PAGE
Shandong Xinhua Pharmaceutical is a supplier offers 57 products (APIs, Excipients or Intermediates).
Find a price of Caffeine bulk with DMF, CEP, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Carbidopa bulk with DMF, CEP, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Etilevodopa bulk with DMF, CEP, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Theophylline bulk with DMF, CEP, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Aspirin bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Glimepiride bulk with DMF, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Icosapent Ethyl bulk with DMF, JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Metamizole bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Phenobarbital bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Prednisolone bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Prednisone bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Trimethoprim bulk with DMF, CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Hydrocortisone bulk with CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Ibuprofen bulk with CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Aspirin bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Calcium Polycarbophil bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Glimepiride bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Hydrocortisone bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Hydrocortisone Acetate bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Ibuprofen bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Ibuprofen Sodium bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Icosapent Ethyl bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Meloxicam bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Omega-3-Acid Ethyl Esters 90 bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Phenazon bulk with CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Piperidin-1-Yl-Acetic Acid bulk with JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Prednisolone bulk with CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Prednisone Acetate bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Propyphenazone bulk with CEP offered by Shandong Xinhua Pharmaceutical
Find a price of Sevelamer Carbonate bulk with DMF offered by Shandong Xinhua Pharmaceutical
Find a price of Theophylline bulk with JDMF offered by Shandong Xinhua Pharmaceutical
Find a price of Amlodipine Besylate bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Hydrocortisone Acetate bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Irisquinone bulk offered by Shandong Xinhua Pharmaceutical
Find a price of FACILITY AND PROCEDURES IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA. bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Amidopyrine bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Aminophylline bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Amobarbital bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Aspirin bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Barbital Sodium bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Bismuth Subsalicylate bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Caffeine bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Calcium Carbonate bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Enoxacin bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Etilevodopa bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Hydrocortisone bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Ibuprofen bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Meloxicam bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Metamizole Magnesium bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Metol bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Nimodipine bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Pipemidic Acid bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Piperacillin Sodium bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Salicylic Acid bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Sumatriptan bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Tramadol Hydrochloride bulk offered by Shandong Xinhua Pharmaceutical
Find a price of Ethyl icosapentaenoic acid bulk offered by Shandong Xinhua Pharmaceutical