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 1Boehringer Ingelheim GmbH
05 1Cambrex Corporation
06 2Curia
07 1Derivados Quimicos SAU
08 2GLAND PHARMA LIMITED
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
A Epipen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epipen, including repackagers and relabelers. The FDA regulates Epipen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epipen 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 Epipen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epipen supplier is an individual or a company that provides Epipen active pharmaceutical ingredient (API) or Epipen finished formulations upon request. The Epipen suppliers may include Epipen API manufacturers, exporters, distributors and traders.
click here to find a list of Epipen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epipen DMF (Drug Master File) is a document detailing the whole manufacturing process of Epipen active pharmaceutical ingredient (API) in detail. Different forms of Epipen DMFs exist exist since differing nations have different regulations, such as Epipen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epipen DMF submitted to regulatory agencies in the US is known as a USDMF. Epipen USDMF includes data on Epipen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epipen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epipen suppliers with USDMF on PharmaCompass.
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