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 1Aurobindo Pharma Limited
03 1Hetero Drugs
04 1Lupin Ltd
05 1MSN Laboratories
06 1Teva Pharmaceutical Industries
01 6GLYCEROL PHENYLBUTYRATE
01 5India
02 1Israel
01 6Active
01 6Complete
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 : 2013-09-16
Pay. Date : 2013-07-02
DMF Number : 27125
Submission : 2013-07-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-15
Pay. Date : 2024-08-29
DMF Number : 40388
Submission : 2024-09-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-13
Pay. Date : 2020-02-26
DMF Number : 34468
Submission : 2020-04-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-12
Pay. Date : 2014-06-12
DMF Number : 28298
Submission : 2014-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-22
Pay. Date : 2024-01-04
DMF Number : 34618
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-08
Pay. Date : 2022-05-24
DMF Number : 37042
Submission : 2022-06-27
Status : Active
Type : II
A Glycerol Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycerol Phenylbutyrate, including repackagers and relabelers. The FDA regulates Glycerol Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycerol 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 Glycerol Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycerol Phenylbutyrate supplier is an individual or a company that provides Glycerol Phenylbutyrate active pharmaceutical ingredient (API) or Glycerol Phenylbutyrate finished formulations upon request. The Glycerol Phenylbutyrate suppliers may include Glycerol Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycerol Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycerol Phenylbutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycerol Phenylbutyrate active pharmaceutical ingredient (API) in detail. Different forms of Glycerol Phenylbutyrate DMFs exist exist since differing nations have different regulations, such as Glycerol Phenylbutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycerol Phenylbutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycerol Phenylbutyrate USDMF includes data on Glycerol Phenylbutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycerol Phenylbutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycerol Phenylbutyrate suppliers with USDMF on PharmaCompass.
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