LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Metrochem API Private Limited
03 2Cohance Lifesciences
04 1Jai Radhe Sales
05 1Apotex Pharmachem
06 1Aspire Lifesciences Pvt Ltd
07 1Delmar Biopharma
08 1Dipharma
09 1Emnar Pharma
10 1Forel Labs
11 2Glenmark Life Sciences
12 1Glenmark Pharmaceuticals
13 1Gurvey & Berry
14 3Hetero Drugs
15 1Juzen Chemical Corporation
16 1Kotobuki Pharmaceutical
17 1Maithri Drugs
18 1Noucor
19 1Perrigo API India Private Limited
20 1Procos
21 1R L Fine Chem
22 1Ramdev Chemicals Pvt Ltd
23 1Sumitomo Pharma
24 1Sun Pharmaceutical Industries Limited
25 1Synergene Active Ingredients Pvt Ltd
26 1Teva API
27 1Unipex
28 1Viatris
29 1Virchow Group
30 1Wockhardt
31 2Yamamoto Corporation
32 1Zydus Lifesciences
01 2Canada
02 1France
03 23India
04 1Israel
05 2Italy
06 5Japan
07 1Spain
08 2U.S.A
01 13Active
02 5Inactive
03 19Blank
01 37Blank
01 1217MF10565
02 1229MF10153
03 1230MF10086
04 1230MF10115
05 1231MF10074
06 1303MF10061
07 1305MF10011
08 1305MF10014
09 1305MF10021
10 28Blank
01 1WC-0041
02 1WC-0057n
03 1WC-0150
04 1WC-0168
05 1WC-0195
06 1WC-0310
07 1WC-0407
08 30Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-12
Pay. Date : 2019-06-11
DMF Number : 31298
Submission : 2017-01-04
Status : Active
Type : II
Registration Number : 231MF10074
Registrant's Address : 215 Atrium, C Wing, 8th Floor, 819-821, Andheri Kurla Road, Chakala MIDC, Chakala, Andheri East, Mumbai-400 093 Maharash
Initial Date of Registration : 2019-03-19
Latest Date of Registration : --
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-137
Start Marketing Date : 2018-10-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2020-12-08
Registration Number : 20201208-211-J-593
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-11-26
DMF Number : 33256
Submission : 2018-10-09
Status : Active
Type : II
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 17511-137
Start Marketing Date : 2018-10-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2020-12-08
Registration Number : 20201208-211-J-593
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18059
Submission : 2005-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12198
Submission : 1996-11-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17661
Submission : 2004-09-02
Status : Active
Type : II
NDC Package Code : 59361-002
Start Marketing Date : 2005-02-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Dong-A ST Co., Ltd.
Registration Date : 2020-07-21
Registration Number : 20200721-211-J-423
Manufacturer Name : Juzen Chemical Corporation
Manufacturer Address : 1-10, Kiba-machi, Toyama-city, Toyama, 930-0806, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18191
Submission : 2005-03-22
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-334
Start Marketing Date : 2023-01-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-14
Pay. Date : 2019-09-27
DMF Number : 31009
Submission : 2016-09-30
Status : Active
Type : II
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
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