Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
01 1Transo-Pharm Handels GmbH
02 1Boehringer Ingelheim GmbH
03 1Cambrex Corporation
04 1Viatris
01 1EPINEPHRINE BITARTRATE
02 1EPINEPHRINE BITARTRATE USP
03 1EPINEPHRINE HYDROGENTARTRATE
04 1EPINEPHRINE TARTRATE/ADRENALINE TARTRATE
01 2Germany
02 2U.S.A
01 3Active
02 1Inactive
01 2Complete
02 2Blank
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2016-12-28
DMF Number : 30996
Submission : 2016-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5779
Submission : 1984-05-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-18
Pay. Date : 2014-06-23
DMF Number : 28385
Submission : 2014-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28750
Submission : 2014-12-13
Status : Active
Type : II
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A Medihaler-Epi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medihaler-Epi, including repackagers and relabelers. The FDA regulates Medihaler-Epi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medihaler-Epi API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Medihaler-Epi supplier is an individual or a company that provides Medihaler-Epi active pharmaceutical ingredient (API) or Medihaler-Epi finished formulations upon request. The Medihaler-Epi suppliers may include Medihaler-Epi API manufacturers, exporters, distributors and traders.
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A Medihaler-Epi DMF (Drug Master File) is a document detailing the whole manufacturing process of Medihaler-Epi active pharmaceutical ingredient (API) in detail. Different forms of Medihaler-Epi DMFs exist exist since differing nations have different regulations, such as Medihaler-Epi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medihaler-Epi DMF submitted to regulatory agencies in the US is known as a USDMF. Medihaler-Epi USDMF includes data on Medihaler-Epi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medihaler-Epi USDMF is kept confidential to protect the manufacturer’s intellectual property.
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