01 1Actavis Inc
02 1Alcami
03 1Apotex Pharmachem
04 1Edmond Pharma
05 1Emcure Pharmaceuticals
06 1Enaltec Labs Private Limited
07 1Industriale Chimica
08 1Ipca Laboratories
09 1Nycomed Austria GmbH
10 1Optimus Pharma
11 1Par Pharmaceutical
12 1Tianjin Weijie Pharmaceutical Co., Ltd.
13 2Zydus Lifesciences
01 5MIDODRINE HYDROCHLORIDE
02 1MIDODRINE HYDROCHLORIDE BULK DRUG SUBSTANCE
03 7MIDODRINE HYDROCHLORIDE USP
04 1MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
01 1Austria
02 1Canada
03 1China
04 7India
05 1Ireland
06 1Italy
07 2U.S.A
01 12Active
02 2Inactive
01 7Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16135
Submission : 2002-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16481
Submission : 2003-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18470
Submission : 2005-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-11
Pay. Date : 2018-10-04
DMF Number : 16017
Submission : 2002-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-12-08
DMF Number : 30990
Submission : 2016-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2016-09-26
DMF Number : 30806
Submission : 2016-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-29
Pay. Date : 2014-05-12
DMF Number : 16006
Submission : 2002-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-16
Pay. Date : 2013-09-25
DMF Number : 27464
Submission : 2013-09-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-01
Pay. Date : 2014-04-29
DMF Number : 28211
Submission : 2014-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30216
Submission : 2016-02-01
Status : Active
Type : II
A Midodrine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midodrine Hydrochloride, including repackagers and relabelers. The FDA regulates Midodrine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midodrine 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 Midodrine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Midodrine Hydrochloride supplier is an individual or a company that provides Midodrine Hydrochloride active pharmaceutical ingredient (API) or Midodrine Hydrochloride finished formulations upon request. The Midodrine Hydrochloride suppliers may include Midodrine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Midodrine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Midodrine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Midodrine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Midodrine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Midodrine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Midodrine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Midodrine Hydrochloride USDMF includes data on Midodrine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Midodrine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Midodrine Hydrochloride suppliers with USDMF on PharmaCompass.
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