Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
01 1Transo-Pharm Handels GmbH
02 13M Company
03 1Amphastar Pharmaceuticals
04 1Cambrex Corporation
05 1Derivados Quimicos SAU
06 2GLAND PHARMA LIMITED
07 1Olon S.p.A
08 1Phlow Corporation
09 1Sun Pharmaceutical Industries Limited
10 1Viatris
11 1Wockhardt
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-11
Pay. Date : 2016-12-28
DMF Number : 30997
Submission : 2016-09-20
Status :
Type : II
100
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A Epipen EZ Pen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epipen EZ Pen, including repackagers and relabelers. The FDA regulates Epipen EZ Pen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epipen EZ Pen 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 Epipen EZ Pen supplier is an individual or a company that provides Epipen EZ Pen active pharmaceutical ingredient (API) or Epipen EZ Pen finished formulations upon request. The Epipen EZ Pen suppliers may include Epipen EZ Pen API manufacturers, exporters, distributors and traders.
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A Epipen EZ Pen DMF (Drug Master File) is a document detailing the whole manufacturing process of Epipen EZ Pen active pharmaceutical ingredient (API) in detail. Different forms of Epipen EZ Pen DMFs exist exist since differing nations have different regulations, such as Epipen EZ Pen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epipen EZ Pen DMF submitted to regulatory agencies in the US is known as a USDMF. Epipen EZ Pen USDMF includes data on Epipen EZ Pen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epipen EZ Pen USDMF is kept confidential to protect the manufacturer’s intellectual property.
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