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01 1Fermion Oy
02 1ChemWerth Inc
03 2Moehs Iberica
04 1Alcami
05 1Ascensus Specialties
06 1Asymchem Laboratories
07 1Emcure Pharmaceuticals
08 1Fuan Pharmaceutical
09 2GLAND PHARMA LIMITED
10 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
11 1Interquim Mexico
12 1Jiangsu Hengrui Medicine
13 1Maithri Drugs
14 1Recipharm AB
15 1Reliable Biopharmaceutical Corporation
16 1Blank
01 1DEXMEDETOMIDINE DRUG SUBSTANCE
02 1DEXMEDETOMIDINE HCI
03 2DEXMEDETOMIDINE HCL
04 6DEXMEDETOMIDINE HYDROCHLORIDE
05 5DEXMEDETOMIDINE HYDROCHLORIDE USP
06 1DEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)
07 1DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
08 1DEXMEDETOMIDINE TRANSDERMAL SYSTEM (DEXMED TX) REDWOOD CITY, CA.
01 4China
02 1Finland
03 4India
04 1Mexico
05 2Spain
06 1Sweden
07 4U.S.A
08 1Blank
01 17Active
02 1Inactive
01 12Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-31
Pay. Date : 2021-08-26
DMF Number : 13810
Submission : 1998-10-30
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-27
Pay. Date : 2012-12-17
DMF Number : 24202
Submission : 2011-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2018-12-11
DMF Number : 33404
Submission : 2018-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-08
Pay. Date : 2022-01-27
DMF Number : 36478
Submission : 2022-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-24
DMF Number : 22681
Submission : 2009-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2012-12-19
DMF Number : 26223
Submission : 2012-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23232
Submission : 2009-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2013-04-29
DMF Number : 26377
Submission : 2012-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2014-04-09
DMF Number : 26984
Submission : 2013-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23132
Submission : 2009-09-28
Status : Active
Type : II
A Dexmedetomidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmedetomidine Hydrochloride, including repackagers and relabelers. The FDA regulates Dexmedetomidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmedetomidine Hydrochloride 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 Dexmedetomidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexmedetomidine Hydrochloride supplier is an individual or a company that provides Dexmedetomidine Hydrochloride active pharmaceutical ingredient (API) or Dexmedetomidine Hydrochloride finished formulations upon request. The Dexmedetomidine Hydrochloride suppliers may include Dexmedetomidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dexmedetomidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexmedetomidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexmedetomidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dexmedetomidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dexmedetomidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexmedetomidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dexmedetomidine Hydrochloride USDMF includes data on Dexmedetomidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexmedetomidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexmedetomidine Hydrochloride suppliers with USDMF on PharmaCompass.
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