Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
01 1Fareva
02 1Aurobindo Pharma Limited
03 1CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
04 1Charioteer
05 2RANBAXY LABORATORIES LIMITED
06 1Trifarma
01 3GANCICLOVIR
02 1GANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE)
03 1GANCICLOVIR USP
04 1GANCICLOVIR USP (NON-STERILE API)
05 1GANCICLOVIR, USP
01 2China
02 3India
03 1Italy
04 1Luxembourg
01 4Active
02 3Inactive
01 3Complete
02 4Blank
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 : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 15567
Submission : 2001-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-07
Pay. Date : 2017-02-15
DMF Number : 31402
Submission : 2017-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-02
Pay. Date : 2015-08-07
DMF Number : 28973
Submission : 2015-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27133
Submission : 2013-05-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16043
Submission : 2002-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19049
Submission : 2005-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23721
Submission : 2010-04-16
Status : Active
Type : II
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