Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Seqens
03 1AKSHAT PHARMA PRIVATE LTD
04 1Amsa Spa
05 1Aurobindo Pharma Limited
06 1BIOFIRST PHARMACEUTICALS LLC
07 1Boehringer Ingelheim GmbH
08 1Breathgreen Pharmaceuticals
09 1CSL Vifor
10 1Endo International
11 1Hainan Poly Pharm
12 1Harman Finochem
13 1Hikma Pharmaceuticals
14 1Hovione
15 1Melody Healthcare Pvt Ltd
16 1Nishchem International Pvt. Ltd
17 1Resonance Laboratories Pvt. Ltd
18 1Siegfried AG
19 1Sifavitor srl
20 1Suven Life Sciences Limited
21 1Swati Spentose
22 1Tai Heng Industry Co., Ltd
23 1Viyash Life Sciences
01 9GLYCOPYRROLATE
02 1GLYCOPYRROLATE INHALATION GRADE
03 9GLYCOPYRROLATE USP
04 1GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE
05 1GLYCOPYRRONIUM BROMIDE
06 1GLYCOPYRRONIUM BROMIDE (MICRONIZED AND NON-MICRONIZED)
07 1VIT-45 POWDER
01 2China
02 1France
03 1Germany
04 9India
05 1Ireland
06 2Italy
07 1Portugal
08 1Spain
09 2Switzerland
10 2U.S.A
11 1United Kingdom
01 18Active
02 5Inactive
01 8Complete
02 15Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-16
Pay. Date : 2017-07-06
DMF Number : 31836
Submission : 2017-07-22
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 18106
Submission : 2005-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19026
Submission : 2005-12-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2015-03-06
DMF Number : 16972
Submission : 2003-11-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16967
Submission : 2003-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-06
DMF Number : 19710
Submission : 2006-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18727
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26470
Submission : 2012-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-27
Pay. Date : 2018-04-24
DMF Number : 29990
Submission : 2015-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21326
Submission : 2008-02-07
Status : Active
Type : II
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