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 1ASolution Pharmaceuticals
03 1HRV Global Life Sciences
04 1Apicore LLC
05 1Apotex Pharmachem
06 1Fareva
07 1ISHIHARA SANGYO KAISHA LTD
08 1Kalintis Healthcare
09 1Laboratori Alchemia Srl
10 1Shenzhen Haorui
11 1Sms Lifesciences
12 1Viatris
01 1Canada
02 1China
03 6India
04 1Italy
05 1Japan
06 1Luxembourg
07 1U.S.A
01 6Active
02 6Blank
01 12Blank
01 1218MF10409
02 11Blank
01 1WC-0110n
02 1WC-0416
03 10Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-27
DMF Number : 38577
Submission : 2023-09-28
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-087
Start Marketing Date : 2021-07-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-12
DMF Number : 24949
Submission : 2011-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13074
Submission : 1998-07-17
Status : Active
Type : II
Registration Number : 218MF10409
Registrant's Address : 1-3-15 Edobori, Nishi-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-04-14
Latest Date of Registration : --
NDC Package Code : 64642-011
Start Marketing Date : 2000-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-02
Pay. Date : 2023-09-20
DMF Number : 38880
Submission : 2023-09-25
Status : Active
Type : II
NDC Package Code : 72166-012
Start Marketing Date : 2021-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22509
Submission : 2009-02-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22200
Submission : 2008-11-17
Status : Active
Type : II
NDC Package Code : 46014-1002
Start Marketing Date : 2013-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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