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
05 1Saurav Chemicals
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 :
Type : II
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PharmaCompass offers a list of Carglumic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Carglumic Acid manufacturer or Carglumic Acid supplier for your needs.
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A (2S)-2-(carbamoylamino)pentanedioic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S)-2-(carbamoylamino)pentanedioic acid, including repackagers and relabelers. The FDA regulates (2S)-2-(carbamoylamino)pentanedioic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S)-2-(carbamoylamino)pentanedioic 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.
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A (2S)-2-(carbamoylamino)pentanedioic acid supplier is an individual or a company that provides (2S)-2-(carbamoylamino)pentanedioic acid active pharmaceutical ingredient (API) or (2S)-2-(carbamoylamino)pentanedioic acid finished formulations upon request. The (2S)-2-(carbamoylamino)pentanedioic acid suppliers may include (2S)-2-(carbamoylamino)pentanedioic acid API manufacturers, exporters, distributors and traders.
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A (2S)-2-(carbamoylamino)pentanedioic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (2S)-2-(carbamoylamino)pentanedioic acid active pharmaceutical ingredient (API) in detail. Different forms of (2S)-2-(carbamoylamino)pentanedioic acid DMFs exist exist since differing nations have different regulations, such as (2S)-2-(carbamoylamino)pentanedioic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (2S)-2-(carbamoylamino)pentanedioic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (2S)-2-(carbamoylamino)pentanedioic acid USDMF includes data on (2S)-2-(carbamoylamino)pentanedioic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2S)-2-(carbamoylamino)pentanedioic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 5 companies offering (2S)-2-(carbamoylamino)pentanedioic acid
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