Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ACS DOBFAR SPA
03 2Akums Lifesciences
04 1Asia Pioneer Pharmaceuticals
05 2Aurobindo Pharma Limited
06 1Eli Lilly
07 1Freemen Nutra
08 1Fresenius Kabi AB Brunna
09 1Fresenius Kabi Anti-Infectives
10 1GSK
11 2Grand Health Industrial Co Ltd
12 1Kukje Pharmaceutical Ind. Co., Ltd. KR 463-839 Seongnam-City
13 1NCPC HUALUAN PHARMACEUTICAL CO LTD
14 2Nectar Lifesciences
15 2Orchid Pharma
16 1Orchidia Pharmaceutical Ind.
17 1Otto Brandes
18 2Qilu Antibiotics Pharmaceutical Co., Ltd.
19 1Qilu Pharmaceutical
20 2Sterile India Pvt. Ltd
21 1TITAN PHARMACEUTICAL CO LTD GUANGDONG
22 1Virchow Group
23 1Vitalpharms
24 1Wockhardt
25 1Zhejiang Dongying Pharmaceutical
26 1Zhuhai United Laboratories Co ., Ltd.
01 11China
02 1Egypt
03 2Germany
04 12India
05 2Italy
06 1South Korea
07 1Sweden
08 2U.S.A
09 1United Kingdom
01 6Active
02 8Inactive
03 19Blank
01 11Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 20Blank
01 33Blank
01 1WC-0131
02 1WC-0145
03 1WC-0378
04 1WC-0378A2
05 1WC-269
06 1WC0131
07 27Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18722
Submission : 2005-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29983
Submission : 2016-11-28
Status : Active
Type : II
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26114
Submission : 2012-05-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15550
Submission : 2001-07-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13675
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16649
Submission : 2003-06-16
Status : Inactive
Type : II
Certificate Number : R0-CEP 2003-236 - Rev 00
Issue Date : 2006-07-07
Type : Chemical
Substance Number : 992
Status : Withdrawn by Holder
Certificate Number : CEP 2014-021 - Rev 02
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 992
Status : Valid
Certificate Number : R1-CEP 1997-044 - Rev 11
Issue Date : 2021-12-17
Type : Chemical
Substance Number : 992
Status : Valid
Certificate Number : R1-CEP 2014-335 - Rev 00
Issue Date : 2022-01-17
Type : Chemical
Substance Number : 992
Status : Valid
Certificate Number : CEP 2021-308 - Rev 01
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 992
Status : Valid
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