LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Evonik
03 1Metrochem API Private Limited
04 1TAPI Technology & API Services
05 1Amara Labs
06 3AstraZeneca
07 1Aurobindo Pharma Limited
08 1Calyx Chemicals & Pharmaceuticals Limited
09 1DEAFARMA
10 1Emcure Pharmaceuticals
11 1Esteve Quimica
12 1Gedeon Richter
13 1Guangzhou Tosun Pharmaceutical
14 3Hetero Drugs
15 1Ipca Laboratories
16 1Lek Pharmaceuticals
17 2Lupin Ltd
18 1Qingdao Qingmei Biotech
19 1RANBAXY LABORATORIES LIMITED
20 1RICHTER THEMIS MEDICARE I PVT LTD
21 1Sms Lifesciences
22 1Themis Medicare
23 1Unimark Remedies Limited
24 1Viatris
25 1Zhejiang Changming Pharmaceuticals
26 2Zhejiang Huahai Pharmaceutical
01 5China
02 1Germany
03 1Hungary
04 16India
05 1Israel
06 1Italy
07 1Slovenia
08 1Spain
09 2U.S.A
10 3United Kingdom
01 8Active
02 11Inactive
03 13Blank
01 1Suspended by Holder
02 8Valid
03 7Withdrawn by Holder
04 16Blank
01 1218MF10592
02 1218MF10860
03 1219MF10148
04 1219MF10198
05 1222MF10145
06 1301MF10069
07 26Blank
01 1WC-0040
02 1WC-0112nA2
03 1WC-0118
04 1WC-0170
05 1WC-0202
06 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
NDC Package Code : 51593-5010
Start Marketing Date : 2006-01-26
End Marketing Date : 2025-12-31
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.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14774
Submission : 2000-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15098
Submission : 2000-10-18
Status : Active
Type : II
Certificate Number : R1-CEP 2001-311 - Rev 04
Issue Date : 2019-09-27
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 301MF10069
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India
Initial Date of Registration : 2019-09-20
Latest Date of Registration : --
Date of Issue : 2019-07-05
Valid Till : 2022-07-04
Written Confirmation Number : WC-0202
Address of the Firm :
NDC Package Code : 57297-511
Start Marketing Date : 2000-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-10
Pay. Date : 2013-03-13
DMF Number : 17626
Submission : 2004-08-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-063 - Rev 04
Issue Date : 2020-03-11
Type : Chemical
Substance Number : 1120
Status : Suspended by Holder
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
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 : 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 : 2025-12-31
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 : Reviewed
Rev. Date : 2021-06-15
Pay. Date : 2021-04-28
DMF Number : 35620
Submission : 2021-03-31
Status : Active
Type : II
NDC Package Code : 14593-944
Start Marketing Date : 2020-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-28
Pay. Date : 2013-03-19
DMF Number : 14801
Submission : 2000-03-24
Status : Active
Type : II
Certificate Number : CEP 2003-064 - Rev 06
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 219MF10148
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2007-04-27
Latest Date of Registration : --
NDC Package Code : 64220-142
Start Marketing Date : 2010-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 6911
Submission : 1987-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7141
Submission : 1987-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10853
Submission : 1994-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18104
Submission : 2005-02-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18117
Submission : 2005-02-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-211 - Rev 04
Issue Date : 2017-12-13
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
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 : 14995
Submission : 2000-08-14
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-121 - Rev 04
Issue Date : 2011-03-16
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 :
Certificate Number : R1-CEP 2012-370 - Rev 00
Issue Date : 2020-02-21
Type : Chemical
Substance Number : 1120
Status : Withdrawn by Holder
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
Certificate Number : CEP 2022-237 - Rev 02
Issue Date : 2024-07-24
Type : Chemical
Substance Number : 1120
Status : Valid
NDC Package Code : 64220-142
Start Marketing Date : 2010-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2018-223 - Rev 00
Issue Date : 2020-05-14
Type : Chemical
Substance Number : 1120
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0112nA2
Address of the Firm :
A ZESTRIL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZESTRIL, including repackagers and relabelers. The FDA regulates ZESTRIL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZESTRIL API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A ZESTRIL supplier is an individual or a company that provides ZESTRIL active pharmaceutical ingredient (API) or ZESTRIL finished formulations upon request. The ZESTRIL suppliers may include ZESTRIL API manufacturers, exporters, distributors and traders.
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