01 1Fujifilm Diosynth Biotechnologies
02 1Roche Diagnostics GmbH
03 1Seratec SAS
01 1L-ALPHA-METHYLDOPATE HYDROCHLORIDE
02 1METHYLDOPATE HYDROCHLORIDE
03 1METHYLDOPATE HYDROCHLORIDE USP
01 1France
02 1Germany
03 1United Kingdom
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5270
Submission : 1983-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5316
Submission : 1984-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24152
Submission : 2010-08-01
Status : Active
Type : II
A Methyldopate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methyldopate Hydrochloride, including repackagers and relabelers. The FDA regulates Methyldopate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methyldopate 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.
A Methyldopate Hydrochloride supplier is an individual or a company that provides Methyldopate Hydrochloride active pharmaceutical ingredient (API) or Methyldopate Hydrochloride finished formulations upon request. The Methyldopate Hydrochloride suppliers may include Methyldopate Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methyldopate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methyldopate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methyldopate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Methyldopate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Methyldopate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methyldopate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methyldopate Hydrochloride USDMF includes data on Methyldopate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methyldopate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methyldopate Hydrochloride suppliers with USDMF on PharmaCompass.
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