Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Aspen API
03 1American Pacific Corporation
04 1Apothecon Pharmaceuticals
05 1Cilag AG
06 1Yichang Humanwell Pharmaceutical
01 1REMIFENTANIL HCL
02 1REMIFENTANIL HCL DRUG SUBSTANCE
03 4REMIFENTANIL HYDROCHLORIDE
01 1China
02 1India
03 1Netherlands
04 1Switzerland
05 2U.S.A
01 6Active
01 5Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25811
Submission : 2011-12-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-12-04
DMF Number : 28106
Submission : 2014-03-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-14
Pay. Date : 2021-02-17
DMF Number : 34303
Submission : 2020-11-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-07
Pay. Date : 2016-09-26
DMF Number : 30156
Submission : 2016-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2013-09-26
DMF Number : 27513
Submission : 2013-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-21
Pay. Date : 2018-09-28
DMF Number : 33151
Submission : 2018-09-21
Status : Active
Type : II
A Remifentanil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remifentanil, including repackagers and relabelers. The FDA regulates Remifentanil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remifentanil 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 Remifentanil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remifentanil supplier is an individual or a company that provides Remifentanil active pharmaceutical ingredient (API) or Remifentanil finished formulations upon request. The Remifentanil suppliers may include Remifentanil API manufacturers, exporters, distributors and traders.
click here to find a list of Remifentanil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Remifentanil DMF (Drug Master File) is a document detailing the whole manufacturing process of Remifentanil active pharmaceutical ingredient (API) in detail. Different forms of Remifentanil DMFs exist exist since differing nations have different regulations, such as Remifentanil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Remifentanil DMF submitted to regulatory agencies in the US is known as a USDMF. Remifentanil USDMF includes data on Remifentanil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remifentanil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Remifentanil suppliers with USDMF on PharmaCompass.
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