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 LIGNOSPAN FORTE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LIGNOSPAN FORTE, including repackagers and relabelers. The FDA regulates LIGNOSPAN FORTE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LIGNOSPAN FORTE 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 LIGNOSPAN FORTE supplier is an individual or a company that provides LIGNOSPAN FORTE active pharmaceutical ingredient (API) or LIGNOSPAN FORTE finished formulations upon request. The LIGNOSPAN FORTE suppliers may include LIGNOSPAN FORTE API manufacturers, exporters, distributors and traders.
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A LIGNOSPAN FORTE DMF (Drug Master File) is a document detailing the whole manufacturing process of LIGNOSPAN FORTE active pharmaceutical ingredient (API) in detail. Different forms of LIGNOSPAN FORTE DMFs exist exist since differing nations have different regulations, such as LIGNOSPAN FORTE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LIGNOSPAN FORTE DMF submitted to regulatory agencies in the US is known as a USDMF. LIGNOSPAN FORTE USDMF includes data on LIGNOSPAN FORTE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LIGNOSPAN FORTE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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