Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1Dr. Reddy's Laboratories
03 1Actavis Inc
04 1Apotex Pharmachem
05 1Corden Pharma Bergamo S.p.A
06 1Hetero Drugs
07 1Par Pharmaceutical
08 1Sandoz B2B
09 1Sun Pharmaceutical Industries Limited
10 1Symed Labs
11 1Unichem Laboratories Limited
12 1Viatris
13 1Zydus Lifesciences
01 1TIZANIDINE HCL
02 1TIZANIDINE HCL USP
03 3TIZANIDINE HYDROCHLORIDE
04 7TIZANIDINE HYDROCHLORIDE USP
05 1TIZANIDINE HYDROCHLORIDE, USP
01 1Canada
02 1Czech Republic
03 6India
04 1Ireland
05 1Italy
06 1Switzerland
07 2U.S.A
01 9Active
02 4Inactive
01 6Complete
02 7Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-10-14
DMF Number : 15525
Submission : 2001-07-04
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-23
Pay. Date : 2013-04-12
DMF Number : 15699
Submission : 2001-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15820
Submission : 2002-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-10
DMF Number : 28176
Submission : 2014-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9242
Submission : 1991-07-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-17
DMF Number : 15727
Submission : 2001-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-09
Pay. Date : 2022-01-27
DMF Number : 33900
Submission : 2019-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15739
Submission : 2001-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22354
Submission : 2008-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-30
DMF Number : 34929
Submission : 2020-06-23
Status : Active
Type : II
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