01 1Indena
02 1Mallinckrodt Pharmaceuticals
03 1Pfizer Inc
04 1Siegfried AG
05 1Vital Laboratories Private Limited
06 1Blank
01 4RESERPINE
02 2RESERPINE USP
01 1India
02 1Ireland
03 1Italy
04 1Switzerland
05 1U.S.A
06 1Blank
01 2Active
02 4Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-25
Pay. Date : 2014-07-07
DMF Number : 4942
Submission : 1983-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 192
Submission : 1956-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 147
Submission : 1954-09-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 136
Submission : 1954-04-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25030
Submission : 2011-02-04
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 193
Submission : 1956-02-17
Status : Inactive
Type : II
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A Reserpine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Reserpine, including repackagers and relabelers. The FDA regulates Reserpine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Reserpine 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 Reserpine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Reserpine supplier is an individual or a company that provides Reserpine active pharmaceutical ingredient (API) or Reserpine finished formulations upon request. The Reserpine suppliers may include Reserpine API manufacturers, exporters, distributors and traders.
click here to find a list of Reserpine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Reserpine DMF (Drug Master File) is a document detailing the whole manufacturing process of Reserpine active pharmaceutical ingredient (API) in detail. Different forms of Reserpine DMFs exist exist since differing nations have different regulations, such as Reserpine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Reserpine DMF submitted to regulatory agencies in the US is known as a USDMF. Reserpine USDMF includes data on Reserpine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Reserpine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Reserpine suppliers with USDMF on PharmaCompass.
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