Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Transo-Pharm USA LLC
03 1HRV Global Life Sciences
04 1Acura Labs
05 1Arene Lifesciences
06 1Cipla
07 1DEAFARMA
08 1Hetero Drugs
09 2Johnson & Johnson Innovative Medicine
10 1Laurus Labs
11 1MSN Laboratories
12 1Reyoung pharmaceutical
13 1Shanghai Desano Bio-Pharmaceutical
14 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
15 1Viatris
01 3China
02 1France
03 7India
04 1Italy
05 4U.S.A
01 8Active
02 1Inactive
03 7Blank
01 16Blank
01 1229MF10183
02 1229MF10184
03 14Blank
01 1WC-0022
02 1WC-0066
03 1WC-0213
04 13Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-07
Pay. Date : 2012-12-26
DMF Number : 23824
Submission : 2010-07-19
Status : Active
Type : II
Registration Number : 229MF10183
Registrant's Address : Little Island Industrial Estate, Little Island, Co. Cork, Ireland
Initial Date of Registration : 2017-10-06
Latest Date of Registration : --
NDC Package Code : 65267-501
Start Marketing Date : 2010-07-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2011-10-28
Registration Number : Su217-14-ND
Manufacturer Name : Janssen Pharmaceutical Sciences Unlimited Company
Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland_x000D_
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-15
Pay. Date : 2015-11-02
DMF Number : 29841
Submission : 2015-12-08
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37479
Submission : 2022-09-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-04
Pay. Date : 2019-07-29
DMF Number : 30773
Submission : 2017-01-02
Status : Active
Type : II
NDC Package Code : 53104-7734
Start Marketing Date : 2018-02-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-30
Pay. Date : 2013-07-08
DMF Number : 27253
Submission : 2013-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39552
Submission : 2024-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26305
Submission : 2012-08-03
Status : Inactive
Type : II
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