Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Fareva
03 1Apotex Pharmachem
04 1ISHIHARA SANGYO KAISHA LTD
05 1Kalintis Healthcare
06 1Viatris
01 2CEVIMELINE HYDROCHLORIDE
02 1CEVIMELINE HYDROCHLORIDE HEMIHYDRATE
03 3CEVIMELINE HYDROCHLORIDE USP
01 1Canada
02 2India
03 1Japan
04 1Luxembourg
05 1U.S.A
01 6Active
01 4Complete
02 2Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-27
DMF Number : 38577
Submission : 2023-09-28
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 : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22200
Submission : 2008-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22509
Submission : 2009-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13074
Submission : 1998-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-09-20
DMF Number : 38880
Submission : 2023-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-12
DMF Number : 24949
Submission : 2011-10-31
Status : Active
Type : II
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