LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Fermion Oy
03 1Cohance Lifesciences
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 1Neuland Laboratories
07 1Arch Pharmalabs
08 1Aurobindo Pharma Limited
09 1Dipharma
10 1Divis Laboratories
11 1Erregierre SpA
12 1F.I.S. Fabbrica Italiana Sintetici
13 1Guangzhou Tosun Pharmaceutical
14 1HEC Pharm
15 1Hermes Chemical
16 1Hetero Drugs
17 1Ipca Laboratories
18 1JRC
19 1Jubilant Generics
20 2Kyongbo Pharmaceutical Co., Ltd
21 2Macleods Pharmaceuticals Limited
22 1Piramal Pharma Solutions
23 1R L Fine Chem
24 1RANBAXY LABORATORIES LIMITED
25 1Ramdev Chemicals Pvt Ltd
26 1Signa S.A. de C.V.
27 1Standard Chem. & Pharm. Co., Ltd
28 1Sun Pharmaceutical Industries Limited
29 2Suven Life Sciences Limited
30 2TATEYAMA KASEI CO LTD
31 1Wockhardt
01 3China
02 1Finland
03 21India
04 3Italy
05 2Japan
06 1Mexico
07 2South Korea
08 2U.S.A
01 15Active
02 4Inactive
03 16Blank
01 1Expired
02 11Valid
03 3Withdrawn by Holder
04 20Blank
01 1226MF10119
02 1227MF10029
03 1227MF10041
04 1227MF10070
05 1230MF10071
06 1302MF10042
07 29Blank
01 1WC-0030
02 1WC-0037
03 1WC-0041
04 1WC-0042
05 1WC-0079
06 1WC-0120
07 1WC-0123
08 1WC-0150
09 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 : 12444
Submission : 1997-03-26
Status : Active
Type : II
Certificate Number : R0-CEP 2021-156 - Rev 00
Issue Date : 2023-06-29
Type : Chemical
Substance Number : 2574
Status : Valid
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2022-01-07
Registration Number : 20220107-209-J-1200
Manufacturer Name : Fermion Oy Hanko Plant
Manufacturer Address : Orioninkatu 2, Hanko, FI-10900, Finland
Available Reg Filing : ASMF |
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2015-09-29
DMF Number : 23937
Submission : 2010-06-30
Status : Active
Type : II
Certificate Number : R1-CEP 2010-337 - Rev 03
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 2574
Status : Valid
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-109
Start Marketing Date : 2010-07-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-03-20
Registration Number : 20190320-209-J-208
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India
Available Reg Filing : CN |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-10
Pay. Date : 2013-02-22
DMF Number : 21526
Submission : 2008-04-11
Status : Active
Type : II
Certificate Number : R1-CEP 2011-191 - Rev 04
Issue Date : 2023-03-24
Type : Chemical
Substance Number : 2574
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2003
Start Marketing Date : 2017-12-14
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 : 2021-01-13
Registration Number : 20180110-209-J-10(1)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Plot Nos. 92,93,94,257,258,259 IDA, Pashamylaram, Isnapur, Patancheru (M), Medak Dist.-502319, Andhra Pradesh, India (204, 6-3-853/1, Meridian Plaza, Ameerpet, Hyderabad-500016, Andhra Pradesh, India )
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29010
Submission : 2015-03-13
Status : Active
Type : II
Certificate Number : R1-CEP 2015-051 - Rev 01
Issue Date : 2022-01-07
Type : Chemical
Substance Number : 2574
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0050
Start Marketing Date : 2015-05-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19385
Submission : 2006-03-01
Status : Active
Type : II
Certificate Number : R0-CEP 2011-211 - Rev 00
Issue Date : 2012-10-15
Type : Chemical
Substance Number : 2574
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20326
Submission : 2007-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23804
Submission : 2010-05-11
Status : Inactive
Type : II
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