Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
01 1Minakem
02 1HRV Global Life Sciences
03 1Acura Labs
04 1Arene Lifesciences
05 1Cipla
06 1DEAFARMA
07 1Hetero Drugs
08 2Johnson & Johnson Innovative Medicine
09 1Laurus Labs
10 1MSN Laboratories
11 1Reyoung pharmaceutical
12 1Shanghai Desano Bio-Pharmaceutical
13 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
14 1Viatris
01 3China
02 1France
03 7India
04 1Italy
05 3U.S.A
01 8Active
02 1Inactive
03 6Blank
01 15Blank
01 1229MF10183
02 1229MF10184
03 13Blank
01 1WC-0022
02 1WC-0066
03 1WC-0213
04 12Blank
Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39552
Submission : 2024-02-27
Status : Active
Type : II
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 : Reviewed
Rev. Date : 2016-03-11
Pay. Date : 2015-09-24
DMF Number : 29301
Submission : 2015-04-16
Status : Active
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
NDC Package Code : 65977-0104
Start Marketing Date : 2011-05-20
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 : 37479
Submission : 2022-09-23
Status : Active
Type : II
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 : Reviewed
Rev. Date : 2018-05-04
Pay. Date : 2018-03-07
DMF Number : 30423
Submission : 2016-03-31
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0052
Start Marketing Date : 2016-02-01
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 : 26305
Submission : 2012-08-03
Status : Inactive
Type : II
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