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 1Cambrex Corporation
03 1F.I.S. Fabbrica Italiana Sintetici
04 1Takeda Pharmaceutical
01 2ESTAZOLAM
02 1ESTAZOLAM (TA-8)
03 1ESTAZOLAM USP
01 1India
02 1Italy
03 1Japan
04 1U.S.A
01 3Active
02 1Inactive
01 1Complete
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 : 2023-11-06
Pay. Date : 2023-09-27
DMF Number : 38680
Submission : 2023-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12228
Submission : 1996-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11784
Submission : 1995-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2859
Submission : 1977-02-10
Status : Inactive
Type : II
A Esilgan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esilgan, including repackagers and relabelers. The FDA regulates Esilgan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esilgan 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 Esilgan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esilgan supplier is an individual or a company that provides Esilgan active pharmaceutical ingredient (API) or Esilgan finished formulations upon request. The Esilgan suppliers may include Esilgan API manufacturers, exporters, distributors and traders.
click here to find a list of Esilgan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esilgan DMF (Drug Master File) is a document detailing the whole manufacturing process of Esilgan active pharmaceutical ingredient (API) in detail. Different forms of Esilgan DMFs exist exist since differing nations have different regulations, such as Esilgan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esilgan DMF submitted to regulatory agencies in the US is known as a USDMF. Esilgan USDMF includes data on Esilgan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esilgan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esilgan suppliers with USDMF on PharmaCompass.
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