Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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01 1Canada
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04 3Japan
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01 2Active
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01 1Valid
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01 1217MF10240
02 1217MF10303
03 1223MF10160
04 1304MF10007
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7799
Submission : 1988-12-02
Status : Active
Type : II
Certificate Number : R0-CEP 2020-328 - Rev 00
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1670
Status : Valid
Registration Number : 217MF10240
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration :
NDC Package Code : 12497-1054
Start Marketing Date : 1988-12-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2562
Submission : 1975-11-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3068
Submission : 1977-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3043
Submission : 1977-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4278
Submission : 1981-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8893
Submission : 1990-12-17
Status : Inactive
Type : II
Certificate Number : R0-CEP 2014-174 - Rev 00
Issue Date : 2016-06-09
Type : Chemical
Substance Number : 1670
Status : Withdrawn by Holder
NDC Package Code : 12497-1054
Start Marketing Date : 1988-12-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registration Number : 223MF10160
Registrant's Address : Zichuan Economic Development Zone, Zibo City, Shandong Province, China
Initial Date of Registration : 2011-11-14
Latest Date of Registration :
NDC Package Code : 73083-001
Start Marketing Date : 2019-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-08-27
Registration Number : 20200629-211-J-663(1)
Manufacturer Name : Shandong Jincheng Bio-pharmaceutical Co., Ltd
Manufacturer Address : Jiao Wang Fu Xian Road North, Dong Yi Road West, Zichuan Economy Development Zone, Zibo City, Shandong Province, China
Registration Number : 217MF10303
Registrant's Address : 1-1-3 Yurakucho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-30
Latest Date of Registration :
Registration Number : 304MF10007
Registrant's Address : Zichuan Economic Development Zone, Zibo City, Shandong Province, China
Initial Date of Registration : 2022-01-11
Latest Date of Registration :
NDC Package Code : 73083-001
Start Marketing Date : 2019-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-08-27
Registration Number : 20200629-211-J-663(1)
Manufacturer Name : Shandong Jincheng Bio-pharmaceutical Co., Ltd
Manufacturer Address : Jiao Wang Fu Xian Road North, Dong Yi Road West, Zichuan Economy Development Zone, Zibo City, Shandong Province, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37051
Submission : 2024-12-03
Status : Active
Type : II
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