Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1LGM Pharma
03 1Temad Co
04 2Hubei Gedian Humanwell Pharmaceutical
05 3Bayer AG
06 1Cipla
07 1Curia
08 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
09 1NEWCHEM SPA
10 1Sicor de Mexico
11 1Swati Spentose
12 1Teva API
13 1Teva Pharmaceutical Industries
14 1Unipex
15 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 5China
02 1France
03 4Germany
04 2India
05 1Iran
06 2Israel
07 1Italy
08 1Mexico
09 2U.S.A
01 1Active
02 5Inactive
03 13Blank
01 10Valid
02 2Withdrawn by Holder
03 7Blank
01 19Blank
01 1WC-0140
02 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18043
Submission : 2005-02-01
Status : Active
Type : II
Certificate Number : R0-CEP 2018-270 - Rev 00
Issue Date : 2020-08-03
Type : Chemical
Substance Number : 1094
Status : Valid
NDC Package Code : 46439-8720
Start Marketing Date : 1998-05-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Certificate Number : R1-CEP 2013-244 - Rev 01
Issue Date : 2023-01-10
Type : Chemical
Substance Number : 1094
Status : Valid
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Certificate Number : R1-CEP 2004-318 - Rev 00
Issue Date : 2011-05-20
Type : Chemical
Substance Number : 1094
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 677
Submission : 1963-09-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-102 - Rev 04
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1094
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2043
Submission : 1973-02-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-168 - Rev 01
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1094
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5168
Submission : 1983-12-20
Status : Inactive
Type : II
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14078
Submission : 1999-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20182
Submission : 2007-04-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-038 - Rev 03
Issue Date : 2019-03-25
Type : Chemical
Substance Number : 1094
Status : Valid
Date of Issue : 2022-06-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0140
Address of the Firm :
NDC Package Code : 53104-7635
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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