Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
01 1Gentec Pharmaceutical Group
02 1SCI Pharmtech
03 3Neuland Laboratories
04 1Pharmathen SA
05 1ALP Pharm
06 1Biocon
07 1FDC
08 1Icrom
09 1Indoco Remedies Limited
10 1Industriale Chimica
11 1Viwit Pharmaceuticals Limited
01 2BRINZOLAMIDE
02 1BRINZOLAMIDE (MICRONIZED, MICRONIZED AND STERILE)
03 1BRINZOLAMIDE MICRONIZED USP
04 3BRINZOLAMIDE USP
05 1BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE)
06 1BRINZOLAMIDE USP (PROCESS-II)
07 1BRINZOLAMIDE USP (STERILE)
08 1BRINZOLAMIDE USP (STERILIZED)
09 2BRINZOLAMIDE, USP
01 2China
02 1Greece
03 6India
04 2Italy
05 1Spain
06 1Taiwan
01 11Active
02 2Inactive
01 6Complete
02 7Blank
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32202
Submission : 2018-02-27
Status : Active
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-20
Pay. Date : 2015-09-25
DMF Number : 29746
Submission : 2015-09-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25817
Submission : 2012-02-22
Status : Active
Type : II
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-06
Pay. Date : 2019-10-21
DMF Number : 34167
Submission : 2019-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26936
Submission : 2013-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36452
Submission : 2023-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-22
DMF Number : 28933
Submission : 2015-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-19
Pay. Date : 2020-02-07
DMF Number : 25478
Submission : 2011-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-24
Pay. Date : 2015-05-15
DMF Number : 28134
Submission : 2014-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-08
Pay. Date : 2012-11-20
DMF Number : 25918
Submission : 2012-03-28
Status : Active
Type : II
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