ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 2Bachem AG
03 1GLAND PHARMA LIMITED
04 1Johnson & Johnson Innovative Medicine
05 1Pisgah Labs
06 1Reliable Biopharmaceutical Corporation
07 1Solara Active Pharma Sciences
01 6ETOMIDATE
02 1ETOMIDATE PROCESS B
03 1ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE
01 2India
02 2Switzerland
03 4U.S.A
01 6Active
02 2Inactive
01 5Complete
02 3Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-13
DMF Number : 20500
Submission : 2007-04-30
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-16
Pay. Date : 2014-10-14
DMF Number : 20234
Submission : 2007-01-29
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-12
Pay. Date : 2023-09-22
DMF Number : 38855
Submission : 2023-09-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-11
Pay. Date : 2020-02-04
DMF Number : 34205
Submission : 2019-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10635
Submission : 1993-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-30
DMF Number : 15983
Submission : 2002-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11229
Submission : 1994-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27580
Submission : 2013-09-20
Status : Active
Type : II
A Etomidate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etomidate, including repackagers and relabelers. The FDA regulates Etomidate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etomidate 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 Etomidate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etomidate supplier is an individual or a company that provides Etomidate active pharmaceutical ingredient (API) or Etomidate finished formulations upon request. The Etomidate suppliers may include Etomidate API manufacturers, exporters, distributors and traders.
click here to find a list of Etomidate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etomidate DMF (Drug Master File) is a document detailing the whole manufacturing process of Etomidate active pharmaceutical ingredient (API) in detail. Different forms of Etomidate DMFs exist exist since differing nations have different regulations, such as Etomidate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etomidate DMF submitted to regulatory agencies in the US is known as a USDMF. Etomidate USDMF includes data on Etomidate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etomidate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etomidate suppliers with USDMF on PharmaCompass.
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