01 1Biotechnica DWC
02 1Cerbios-Pharma SA
03 1Chongqing Huapont Pharmaceutical
04 3GMT Fine Chemicals SA
05 1MERCK & CIE
06 1SEACROSS PHARMACEUTICALS
07 1Sichuan Huiyu Pharmaceutical
01 1Algeria
02 2China
03 5Switzerland
04 1United Kingdom
01 4Active
02 5Blank
01 3Valid
02 6Blank
01 1217MF11273
02 1217MF11281
03 1218MF10307
04 1218MF10451
05 1230MF10073
06 4Blank
01 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38433
Submission : 2023-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20327
Submission : 2007-02-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-266 - Rev 06
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 1606
Status : Valid
Registration Number : 217MF11281
Registrant's Address : Weisshausmatte CH-6460 Altdorf Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration : --
NDC Package Code : 54784-018
Start Marketing Date : 2008-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2021-05-24
Registration Number : 20210524-211-J-825
Manufacturer Name : Merck & Cie
Manufacturer Address : Im Laternenacker 5, 8200 Schaffhausen, Switzerland
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 23437
Submission : 2010-01-04
Status : Active
Type : II
Certificate Number : CEP 2004-183 - Rev 04
Issue Date : 2024-02-08
Type : Chemical
Substance Number : 1606
Status : Valid
Registration Number : 217MF11273
Registrant's Address : Via Figino 6,6917 Barbengo/Lugano, Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration : --
NDC Package Code : 54239-007
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-20
Pay. Date : 2013-09-26
DMF Number : 25198
Submission : 2011-08-10
Status : Active
Type : II
Certificate Number : CEP 2008-320 - Rev 07
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 1606
Status : Valid
Registration Number : 218MF10307
Registrant's Address : 6, rue des Iles CH-2108 COUVET Switzerland
Initial Date of Registration : 2006-02-28
Latest Date of Registration : --
NDC Package Code : 68034-101
Start Marketing Date : 2012-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 230MF10073
Registrant's Address : 6, rue des Iles CH-2108 COUVET Switzerland
Initial Date of Registration : 2018-06-20
Latest Date of Registration : --
NDC Package Code : 68034-101
Start Marketing Date : 2012-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 218MF10451
Registrant's Address : 6, rue des Iles CH-2108 COUVET Switzerland
Initial Date of Registration : 2006-04-27
Latest Date of Registration : --
NDC Package Code : 68034-101
Start Marketing Date : 2012-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2024-01-19
Registration Number : 20240119-210-J-1598
Manufacturer Name : Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.
Manufacturer Address : No. 666 Rongjun Road, Nanjin Avenue Hechuan District, Chongqing China
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