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 1Jai Radhe Sales
03 1Macsen Labs
04 1Allastir
05 1Anthem Biosciences
06 1Cerbios-Pharma SA
07 1Chemspec-API
08 1Lupin Ltd
09 1Wuxi Taxus Pharmaceutical
01 1China
02 6India
03 1Switzerland
04 1U.S.A
01 4Active
02 5Blank
01 9Blank
01 9Blank
01 1WC-0523
02 8Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-062
Start Marketing Date : 2020-03-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-17
Pay. Date : 2021-12-14
DMF Number : 36528
Submission : 2021-12-20
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-05
Written Confirmation Number : WC-0523
Address of the Firm :
NDC Package Code : 76438-005
Start Marketing Date : 2021-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-21
Pay. Date : 2016-08-31
DMF Number : 26016
Submission : 2012-04-30
Status : Active
Type : II
NDC Package Code : 54239-008
Start Marketing Date : 2012-01-01
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 : 25789
Submission : 2013-03-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2013-04-03
DMF Number : 26531
Submission : 2013-03-12
Status : Active
Type : II
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