Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Aspen API
03 1Fareva
04 13M Drug Delivery Systems
05 1Bayer AG
06 1Catalent Pharma Solutions
07 1Gedeon Richter
08 1Lupin Ltd
09 1Merck & Co
10 1Perlen Packaging
11 1Productos Quimicos Naturales
01 1(18F) FES,16 ALPHA-[18F]-FLUORO-17BETAESTRADIOL
02 117 ALPHA-ESTRADIOL
03 1ALPHA-ESTRADIOL
04 2ESTRADIOL
05 1ESTRADIOL HEMIHYDRATE
06 2ESTRADIOL HEMIHYDRATE USP
07 1ESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM
08 1ESTRADIOL USP
09 1ESTRADIOL VAGINAL SOFT GELATIN CAPSULES
01 1Germany
02 1Hungary
03 2India
04 1Luxembourg
05 1Mexico
06 1Netherlands
07 1Switzerland
08 3U.S.A
01 7Active
02 4Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-23
DMF Number : 34147
Submission : 2019-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-20
DMF Number : 3829
Submission : 1980-05-21
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-04-24
DMF Number : 22972
Submission : 2009-07-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9841
Submission : 1992-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-08
DMF Number : 4684
Submission : 1982-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22843
Submission : 2009-06-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2016-04-26
DMF Number : 4066
Submission : 1981-01-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-02-26
DMF Number : 25816
Submission : 2012-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1388
Submission : 1969-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23856
Submission : 2010-05-27
Status : Inactive
Type : II
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