LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Cohance Lifesciences
03 1HRV Global Life Sciences
04 1Medichem S.A
05 1Arevipharma
06 2Aurore Life Sciences
07 1Cambrex Corporation
08 1Global Calcium
09 1Jiangsu Nhwa Pharmaceutical
10 1Jin Dun Medical
11 1Mankind Pharma
12 1Medilux Laboratories
13 1Otto Brandes
14 1R L Fine Chem
15 1SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL
16 1SMS Pharmaceuticals
17 1Sandoz B2B
18 1Shouguang Fukang Pharmaceutical Co., Ltd
19 1Smilax Laboratories Limited
20 1Viatris
21 1WUHAN SHIJI PHARMACEUTICAL CO LTD
22 1Wuhan Shiji Pharmaceutical
23 3Blank
01 6China
02 2Germany
03 10India
04 1Spain
05 1Switzerland
06 3U.S.A
07 3Blank
01 11Active
02 4Inactive
03 11Blank
01 8Valid
02 1Withdrawn by Holder
03 17Blank
01 1301MF10021
02 25Blank
01 1WC-0015
02 1WC-0104
03 1WC-0119
04 1WC-0119A10
05 1WC-0195
06 21Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status : Active
Type : II
Certificate Number : R0-CEP 2018-192 - Rev 01
Issue Date : 2021-02-12
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1010
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2015-01-26
DMF Number : 10534
Submission : 1993-10-21
Status : Active
Type : II
Certificate Number : R1-CEP 2008-151 - Rev 00
Issue Date : 2015-07-13
Type : Chemical
Substance Number : 1191
Status : Valid
Registration Number : 301MF10021
Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona) Spain
Initial Date of Registration : 2019-06-25
Latest Date of Registration : --
NDC Package Code : 53296-0033
Start Marketing Date : 2010-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2020-05-04
Registration Number : 20180903-209-J-157(2)
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36869
Submission : 2022-03-23
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19822
Submission : 2006-10-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-29
Pay. Date : 2013-09-25
DMF Number : 25182
Submission : 2011-08-03
Status : Active
Type : II
Certificate Number : R1-CEP 2012-006 - Rev 00
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1191
Status : Valid
NDC Package Code : 64374-004
Start Marketing Date : 2016-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-04
Pay. Date : 2013-08-27
DMF Number : 27379
Submission : 2013-09-17
Status : Active
Type : II
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-706
Start Marketing Date : 2015-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-26
Pay. Date : 2022-12-12
DMF Number : 36645
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : R0-CEP 2021-110 - Rev 00
Issue Date : 2022-07-08
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11195
Submission : 1994-11-16
Status : Active
Type : II
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