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 1Metrochem API Private Limited
03 1ALP Pharm
04 1MSN Laboratories
05 1Torrent Pharmaceuticals Limited
01 5STIRIPENTOL
01 1China
02 4India
01 5Active
01 2Complete
02 3Blank
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 : 2019-04-11
Pay. Date : 2019-02-22
DMF Number : 33252
Submission : 2019-03-05
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38097
Submission : 2023-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35817
Submission : 2021-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34328
Submission : 2019-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-22
Pay. Date : 2023-12-12
DMF Number : 39256
Submission : 2023-12-29
Status : Active
Type : II
A Stiripentol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stiripentol, including repackagers and relabelers. The FDA regulates Stiripentol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stiripentol 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 Stiripentol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Stiripentol supplier is an individual or a company that provides Stiripentol active pharmaceutical ingredient (API) or Stiripentol finished formulations upon request. The Stiripentol suppliers may include Stiripentol API manufacturers, exporters, distributors and traders.
click here to find a list of Stiripentol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Stiripentol DMF (Drug Master File) is a document detailing the whole manufacturing process of Stiripentol active pharmaceutical ingredient (API) in detail. Different forms of Stiripentol DMFs exist exist since differing nations have different regulations, such as Stiripentol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Stiripentol DMF submitted to regulatory agencies in the US is known as a USDMF. Stiripentol USDMF includes data on Stiripentol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stiripentol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Stiripentol suppliers with USDMF on PharmaCompass.
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