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 2Seqens
03 1Apothecon Pharmaceuticals
04 1Scandinavian Formulas
05 1Sri Krishna Pharmaceuticals
06 1Vintage Pharmaceuticals-Charlotte
01 14-PHENYLBUTYRIC ACID SODIUM SALT
02 2SODIUM 4-PHENYLBUTYRATE
03 1SODIUM PHENYLBUTYRATE GRANULES 100% (KRISOSPB-100)
04 2SODIUM PHENYLBUTYRATE USP
05 1SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-GRAM TABLETS
01 2France
02 3India
03 2U.S.A
01 6Active
02 1Inactive
01 2Complete
02 5Blank
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 : 2023-11-15
Pay. Date : 2023-09-27
DMF Number : 38890
Submission : 2023-09-29
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-08
DMF Number : 9716
Submission : 1992-06-08
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22048
Submission : 2008-10-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20699
Submission : 2007-07-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17536
Submission : 2004-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23972
Submission : 2010-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25560
Submission : 2011-12-22
Status : Active
Type : II
A Sodium Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Phenylbutyrate, including repackagers and relabelers. The FDA regulates Sodium Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Phenylbutyrate 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 Sodium Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Phenylbutyrate supplier is an individual or a company that provides Sodium Phenylbutyrate active pharmaceutical ingredient (API) or Sodium Phenylbutyrate finished formulations upon request. The Sodium Phenylbutyrate suppliers may include Sodium Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Phenylbutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Phenylbutyrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Phenylbutyrate DMFs exist exist since differing nations have different regulations, such as Sodium Phenylbutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Phenylbutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Phenylbutyrate USDMF includes data on Sodium Phenylbutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Phenylbutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Phenylbutyrate suppliers with USDMF on PharmaCompass.
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