LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Neuland Laboratories
03 1USV Private Limited
04 1Actavis Inc
05 2Alembic Pharmaceuticals Limited
06 1Almelo
07 1Cadila Pharmaceuticals
08 1Chemeca Drugs
09 1Estechpharma
10 1Glenmark Life Sciences
11 1Glenmark Pharmaceuticals
12 1Ind Swift Laboratories Limited
13 1Orchid Pharma
14 1Synthimed Labs
15 1Torrent Pharmaceuticals Limited
16 1Urquima S.A. Grupo Uriach
17 1Xian Libang Pharmaceutical Co.,Ltd
18 1Zhejiang Huahai Pharmaceutical
01 2China
02 13India
03 1Ireland
04 1South Korea
05 1Spain
06 1U.S.A
01 8Active
02 3Inactive
03 8Blank
01 5Valid
02 14Blank
01 1227MF10031
02 1227MF10077
03 1227MF10080
04 1228MF10173
05 15Blank
01 1WC-0003
02 1WC-0012
03 1WC-0036
04 1WC-0057n
05 1WC-0081
06 1WC-0082
07 13Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19590
Submission : 2006-07-10
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0133
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-209-J-678
Manufacturer Name : Neuland laboratories Ltd. (Unit-I)
Manufacturer Address : Sy. No. 347, 473, 474, 490/2 Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District-502313 Telangana State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19045
Submission : 2005-12-19
Status : Active
Type : II
Date of Issue : 2022-06-27
Valid Till : 2025-06-02
Written Confirmation Number : WC-0012
Address of the Firm :
NDC Package Code : 62147-0008
Start Marketing Date : 2010-02-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-11-16
Pay. Date : 2022-11-14
DMF Number : 20593
Submission : 2007-06-12
Status : Active
Type : II
Certificate Number : R0-CEP 2017-242 - Rev 01
Issue Date : 2022-12-13
Type : Chemical
Substance Number : 2604
Status : Valid
Registration Number : 227MF10031
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India
Initial Date of Registration : 2015-01-23
Latest Date of Registration : --
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-853
Start Marketing Date : 2007-06-12
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 : 21938
Submission : 2008-10-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20829
Submission : 2007-04-25
Status : Active
Type : II
Certificate Number : CEP 2017-026 - Rev 01
Issue Date : 2024-09-13
Type : Chemical
Substance Number : 2604
Status : Valid
NDC Package Code : 64220-121
Start Marketing Date : 2011-02-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-17
Pay. Date : 2023-01-13
DMF Number : 18564
Submission : 2005-07-30
Status : Active
Type : II
Registration Number : 227MF10080
Registrant's Address : Village-Bhagwanpur, Barwala Road, Derabassi-140 507 District-S. A. S. Nagar (Mohali)Punjab, India
Initial Date of Registration : 2015-03-12
Latest Date of Registration : --
Date of Issue : 2022-06-03
Valid Till : 2025-05-27
Written Confirmation Number : WC-0003
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19780
Submission : 2006-09-11
Status : Active
Type : II
Certificate Number : R0-CEP 2022-227 - Rev 00
Issue Date : 2023-08-09
Type : Chemical
Substance Number : 2604
Status : Valid
Registration Number : 228MF10173
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2016-08-29
Latest Date of Registration : --
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-10-25
Registration Number : 20190104-209-J-175(1)
Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-I).
Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17880
Submission : 2004-12-08
Status : Inactive
Type : II
Certificate Number : R1-CEP 2016-117 - Rev 00
Issue Date : 2022-06-10
Type : Chemical
Substance Number : 2604
Status : Valid
Registration Number : 227MF10077
Registrant's Address : Poli(')gon Industrial Riera de Caldes Avinguda Cami(') Reial 51-57 08184 Palau-Solita(') i Pleamans Barcelona SPAIN
Initial Date of Registration : 2015-03-12
Latest Date of Registration : --
NDC Package Code : 54752-0005
Start Marketing Date : 1997-09-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2019-09-06
Registration Number : 20190906-209-J-261
Manufacturer Name : URQUIMA SA
Manufacturer Address : Arnau de vilanova 22-42 08105 Sant fost de Campsentelles (Barcelona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19933
Submission : 2006-08-18
Status : Inactive
Type : II
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