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 4CARGLUMIC ACID
01 1India
02 2Italy
03 1Switzerland
01 4Active
01 3Complete
02 1Blank
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 : 2019-01-11
Pay. Date : 2018-12-14
DMF Number : 33166
Submission : 2018-12-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-06
Pay. Date : 2024-02-01
DMF Number : 39329
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-03
Pay. Date : 2023-09-27
DMF Number : 38477
Submission : 2023-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26955
Submission : 2013-03-06
Status : Active
Type : II
A Carglumic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carglumic Acid, including repackagers and relabelers. The FDA regulates Carglumic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carglumic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Carglumic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carglumic Acid supplier is an individual or a company that provides Carglumic Acid active pharmaceutical ingredient (API) or Carglumic Acid finished formulations upon request. The Carglumic Acid suppliers may include Carglumic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Carglumic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carglumic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Carglumic Acid active pharmaceutical ingredient (API) in detail. Different forms of Carglumic Acid DMFs exist exist since differing nations have different regulations, such as Carglumic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carglumic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Carglumic Acid USDMF includes data on Carglumic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carglumic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carglumic Acid suppliers with USDMF on PharmaCompass.
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