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 1Aarti Pharmalabs
03 1CF Pharma
04 1Apotex Pharmachem
05 1Arevipharma
06 1COSMA S.p.A
07 1Cipla
08 1Emcure Pharmaceuticals
09 1Fresenius Kabi AB Brunna
10 1GENESEN LABS LTD
11 1Gedeon Richter
12 1Hetero Drugs
13 1Kekule Pharma
14 1Lupin Ltd
15 1MSN Laboratories
16 1Mac-Chem Products (India) Pvt.Ltd
17 1Olon S.p.A
18 1Shilpa Medicare
19 1Sumitomo Chemical
20 1Sun Pharmaceutical Industries Limited
21 1TAPI Technology & API Services
22 1Tai Heng Industry Co., Ltd
23 1UQUIFA
24 1Viatris
25 1Zhejiang Hisun Pharmaceutical
01 9BICALUTAMIDE
02 1BICALUTAMIDE (FORM-H1)
03 1BICALUTAMIDE (MICRONIZED)
04 1BICALUTAMIDE ADSORBATE
05 2BICALUTAMIDE DRUG SUBSTANCE
06 1BICALUTAMIDE MILLED Z
07 8BICALUTAMIDE USP
08 1BICALUTAMIDE USP [ROUTE CODE - "BL"]
09 1Bicalutamide
01 1Canada
02 2China
03 1Germany
04 2Hungary
05 11India
06 1Israel
07 2Italy
08 1Japan
09 1Luxembourg
10 1Spain
11 1Sweden
12 1U.S.A
01 12Active
02 13Inactive
01 4Complete
02 21Blank
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 : 2015-08-19
Pay. Date : 2015-08-10
DMF Number : 21863
Submission : 2008-08-04
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 : 2023-11-22
Pay. Date : 2023-11-09
DMF Number : 20502
Submission : 2007-05-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22158
Submission : 2008-11-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18723
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18496
Submission : 2005-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19624
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20263
Submission : 2007-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17008
Submission : 2003-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21103
Submission : 2007-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 17878
Submission : 2004-12-03
Status : Active
Type : II
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