Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Gangwal Healthcare
03 1Aarti Pharmalabs
04 1Neuland Laboratories
05 1Porton Pharma Solutions
06 1Amphastar Pharmaceuticals
07 1Asymchem Laboratories
08 3Cipla
09 1GSK
10 2Hovione
11 2MSN Laboratories
12 2Melody Healthcare Pvt Ltd
13 1Natco Pharma
14 1Viatris
15 1Zydus Lifesciences
01 8SALMETEROL XINAFOATE
02 1SALMETEROL XINAFOATE API
03 1SALMETEROL XINAFOATE INHALATION GRADE
04 1SALMETEROL XINAFOATE IP/BP
05 1SALMETEROL XINAFOATE MICRONIZED
06 6SALMETEROL XINAFOATE USP
07 1SALMETEROL XINAFOATE USP [ROUTE CODE - SX]
08 1SALMETEROL XINAFOATE, USP
01 2China
02 12India
03 2Portugal
04 1Spain
05 2U.S.A
06 1United Kingdom
01 13Active
02 7Inactive
01 7Complete
02 13Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-12
Pay. Date : 2015-05-20
DMF Number : 23914
Submission : 2010-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26863
Submission : 2013-02-04
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-05
Pay. Date : 2015-01-05
DMF Number : 22054
Submission : 2008-10-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-14
Pay. Date : 2015-12-07
DMF Number : 22973
Submission : 2009-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37070
Submission : 2022-05-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-06
Pay. Date : 2015-08-21
DMF Number : 29491
Submission : 2015-08-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24582
Submission : 2011-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-25
Pay. Date : 2017-08-18
DMF Number : 30387
Submission : 2016-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31242
Submission : 2016-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-27
Pay. Date : 2015-05-08
DMF Number : 18394
Submission : 2005-06-03
Status : Active
Type : II
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