01 1Boehringer Ingelheim Pharma GmbH & Co. K.G.
02 1Cambrex Profarmaco Milano S. r. l.
03 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Adrenalin
02 2Epinephrine
01 1Germany
02 1Taiwan
03 1U.S.A
Registration Number : 218MF10483
Registrant's Address : Binger Strasse 173, 55216 Ingelheim am Rhein Germany
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2015-12-15
Registration Number : 226MF10196
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2014-10-27
Latest Date of Registration : 2020-04-22
Registration Number : 230MF10047
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2018-03-27
Latest Date of Registration : 2018-03-27
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Epipen Drug Master File in Japan (Epipen JDMF) empowers Epipen API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Epipen JDMF during the approval evaluation for pharmaceutical products. At the time of Epipen JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Epipen suppliers with JDMF on PharmaCompass.
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