Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
01 1Rochem International Inc
02 1Bazayan & Co
03 1Calao s.r.l. IT 20157 Milano
04 1Cambrex Corporation
05 1Chugoku Kayaku
06 1Curia
07 1DOTTIKON EXCLUSIVE SYNTHESIS AG
08 3Dipharma
09 1EIRCHEM Pharma Services
10 1IQT Industrias Quimicas Taubate
11 1J. P. Laboratories Pvt. Ltd.,
12 1JP Laboratories
13 1Kremers Urban Pharmaceuticals
14 4Lunan Pharmaceutical
15 1Muromachi Chemicals Inc
16 1NORDIC SYNTHESIS AB
17 1Precise Group
18 1RA CHEM PHARMA LIMITED
19 1Shandong Keyuan Pharmaceutical
20 1WHYTE CHEMICALS
21 1Zhuhai Rundu Pharmaceutical
22 1Zim Laboratories
23 2Blank
01 1Brazil
02 6China
03 6India
04 1Ireland
05 3Italy
06 2Japan
07 1Sweden
08 1Switzerland
09 5U.S.A
10 1United Kingdom
11 2Blank
01 5Active
02 7Inactive
03 17Blank
01 7Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 19Blank
01 1217MF10798
02 1218MF10745
03 1225MF10192
04 1229MF10189
05 25Blank
01 1WC-0106
02 1WC0106
03 27Blank
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6362
Submission : 1984-10-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-28
Pay. Date : 2013-12-24
DMF Number : 23216
Submission : 2009-10-21
Status : Active
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23217
Submission : 2009-10-21
Status : Active
Type : II
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-22
Pay. Date : 2018-11-26
DMF Number : 29555
Submission : 2015-07-17
Status : Active
Type : II
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-24
DMF Number : 6778
Submission : 1987-01-09
Status : Active
Type : II
Certificate Number : R1-CEP 2007-261 - Rev 02
Issue Date : 2021-12-01
Type : Chemical
Substance Number : 1118
Status : Valid
Registration Number : 218MF10745
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2006-09-06
Latest Date of Registration : --
NDC Package Code : 46438-0025
Start Marketing Date : 2005-10-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-209-J-1260
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via XXIV Maggio 40-33036 Mereto di Tomba (UD) Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6789
Submission : 1987-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20816
Submission : 2007-08-24
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-153 - Rev 00
Issue Date : 2022-05-11
Type : Chemical
Substance Number : 1118
Status : Valid
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21809
Submission : 2008-06-18
Status : Inactive
Type : II
Certificate Number : CEP 2008-112 - Rev 01
Issue Date : 2024-04-10
Type : Chemical
Substance Number : 1118
Status : Valid
Registration Number : 229MF10189
Registrant's Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan City, Shandong, China
Initial Date of Registration : 2017-10-26
Latest Date of Registration : --
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2022-04-05
Registration Number : 20220324-209-J-1239(1)
Manufacturer Name : Shandong Keyuan Pharmaceutical Co., Ltd.
Manufacturer Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan, Shandong, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5607
Submission : 1984-11-15
Status : Inactive
Type : II
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