LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Evonik
03 1Metrochem API Private Limited
04 1Amara Labs
05 3AstraZeneca
06 1Aurobindo Pharma Limited
07 1Calyx Chemicals & Pharmaceuticals Limited
08 1DEAFARMA
09 1Emcure Pharmaceuticals
10 1Esteve Quimica
11 1Gedeon Richter
12 1Guangzhou Tosun Pharmaceutical
13 3Hetero Drugs
14 1Ipca Laboratories
15 1Lek Pharmaceuticals
16 2Lupin Ltd
17 1Qingdao Qingmei Biotech
18 1RANBAXY LABORATORIES LIMITED
19 2RICHTER THEMIS MEDICARE I PVT LTD
20 1Sms Lifesciences
21 1TAPI Technology & API Services
22 1Themis Medicare
23 1Unimark Remedies Limited
24 1Viatris
25 1Zhejiang Changming Pharmaceuticals
26 2Zhejiang Huahai Pharmaceutical
01 5China
02 1Germany
03 1Hungary
04 17India
05 1Israel
06 1Italy
07 1Slovenia
08 1Spain
09 2U.S.A
10 3United Kingdom
01 8Active
02 11Inactive
03 14Blank
01 1Suspended by Holder
02 8Valid
03 7Withdrawn by Holder
04 17Blank
01 1218MF10592
02 1218MF10860
03 1219MF10148
04 1219MF10198
05 1222MF10145
06 1224MF10087
07 1301MF10069
08 26Blank
01 1WC-0040
02 1WC-0112
03 1WC-0112-A3
04 1WC-0118
05 1WC-0170
06 1WC-0202
07 27Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19138
Submission : 2006-01-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-011 - Rev 07
Issue Date : 2020-12-09
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 224MF10087
Registrant's Address : Rellinghauser Strasse 1-11 45128 Essen, Germany
Initial Date of Registration : 2012-04-13
Latest Date of Registration : --
NDC Package Code : 51593-5010
Start Marketing Date : 2006-01-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-05-14
Registration Number : 20210514-209-J-989
Manufacturer Name : Evonik Operations GmbH@Evonik Rexim SAS
Manufacturer Address : Rodenbacher Chaussee 4 63457 Hanau Germany@33 rue de Verdun 80400 Ham, FRANCE
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-05
Pay. Date : 2013-09-27
DMF Number : 27385
Submission : 2013-09-10
Status : Active
Type : II
Certificate Number : R1-CEP 2011-002 - Rev 00
Issue Date : 2017-01-23
Type : Chemical
Substance Number : 1120
Status : Valid
NDC Package Code : 45648-001
Start Marketing Date : 2010-04-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-11-29
DMF Number : 16510
Submission : 2003-03-21
Status : Active
Type : II
Certificate Number : CEP 2016-197 - Rev 02
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 222MF10145
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA
Initial Date of Registration : 2010-04-22
Latest Date of Registration : --
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0009
Start Marketing Date : 1987-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-08
Pay. Date : 2023-03-16
DMF Number : 38132
Submission : 2023-03-03
Status : Active
Type : II
Certificate Number : CEP 2022-434 - Rev 02
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 218MF10592
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Andhra Pradesh, INDIA
Initial Date of Registration : 2006-06-22
Latest Date of Registration : --
NDC Package Code : 65977-0009
Start Marketing Date : 1987-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15026
Submission : 2000-09-07
Status : Inactive
Type : II
Certificate Number : R0-CEP 2006-065 - Rev 00
Issue Date : 2008-08-12
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12912
Submission : 1998-01-26
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-051 - Rev 03
Issue Date : 2011-03-23
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
Registration Number : 219MF10198
Registrant's Address : Budapest, Gyomroi ut 19-21, Hungary, H-1103
Initial Date of Registration : 2007-06-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12968
Submission : 1998-04-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-024 - Rev 04
Issue Date : 2015-06-30
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21206
Submission : 2007-12-18
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-134 - Rev 01
Issue Date : 2014-09-29
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
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