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 1HRV Global Life Sciences
03 1Apothecon Pharmaceuticals
04 1Aurobindo Pharma Limited
05 1CPL Sachse
06 1ISP Chemicals, LLC
07 1Lonza Group
08 1Par Pharmaceutical
09 1Raks Pharma
10 1Viatris
01 1Germany
02 5India
03 1Switzerland
04 3U.S.A
01 5Active
02 2Inactive
03 3Blank
01 10Blank
01 10Blank
01 1WC-0416
02 9Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-29
Pay. Date : 2018-01-12
DMF Number : 32443
Submission : 2018-01-25
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 : 58159-044
Start Marketing Date : 2022-10-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25580
Submission : 2012-01-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-11
Pay. Date : 2019-01-28
DMF Number : 33477
Submission : 2018-12-27
Status : Active
Type : II
NDC Package Code : 59651-298
Start Marketing Date : 2024-01-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-16
Pay. Date : 2020-03-05
DMF Number : 31746
Submission : 2017-12-28
Status : Active
Type : II
NDC Package Code : 76339-143
Start Marketing Date : 2019-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (4.999kg/4.999kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20011
Submission : 2006-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4264
Submission : 1981-09-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16593
Submission : 2003-05-13
Status : Inactive
Type : II
NDC Package Code : 47621-309
Start Marketing Date : 2019-09-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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