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 1Dipharma SA
03 1Procos
04 1Recordati
01 1India
02 2Italy
03 1Switzerland
01 4Active
01 4Blank
01 1227MF10276
02 3Blank
01 1WC-0416
02 3Blank
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 : 2019-01-11
Pay. Date : 2018-12-14
DMF Number : 33166
Submission : 2018-12-07
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 : 58159-053
Start Marketing Date : 2017-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-03
Pay. Date : 2023-09-27
DMF Number : 38477
Submission : 2023-07-12
Status : Active
Type : II
NDC Package Code : 46016-1180
Start Marketing Date : 2019-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-06
Pay. Date : 2024-02-01
DMF Number : 39329
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26955
Submission : 2013-03-06
Status : Active
Type : II
Registration Number : 227MF10276
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2015-12-11
Latest Date of Registration : --
A N-Carbamylglutamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Carbamylglutamate, including repackagers and relabelers. The FDA regulates N-Carbamylglutamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Carbamylglutamate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A N-Carbamylglutamate supplier is an individual or a company that provides N-Carbamylglutamate active pharmaceutical ingredient (API) or N-Carbamylglutamate finished formulations upon request. The N-Carbamylglutamate suppliers may include N-Carbamylglutamate API manufacturers, exporters, distributors and traders.
click here to find a list of N-Carbamylglutamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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