01 1Boehringer Ingelheim GmbH & Co.KG
02 1Chongqing Succeway Pharmaceutical Co., Ltd. @Jeil Pharmaceutical Co., Ltd. @[Starting Material (Epinastine Bromide) Manufacturer ①] Pharmacostec Co., Ltd. @[Starting Material (Epinastine Bromide) Manufacturer ②] Dong-in Chemical Co., Ltd. @[Starting Mater
03 2Excella GmbH & Co. KG
04 1Hubei Haosun Pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd.
05 5ICROM SpA
06 1Pharmacostec Co., Ltd.
07 1Yuil Farm Tech Co., Ltd.
01 1Boehringer Ingelheim Korea Ltd.
02 1Colmar Pharma Co., Ltd.
03 1Donggu Biopharmaceutical Co., Ltd.
04 1Insung Trading Co., Ltd.
05 1Jeil Pharmaceutical Co., Ltd.
06 1Jeil Pharmtech Co., Ltd.
07 1Kukjeon Pharmaceutical Co., Ltd.
08 1Pharmacostec Co., Ltd.
09 2Samchundang Pharmaceutical Co., Ltd.
10 1Samoh Pharmaceutical Co., Ltd.
11 1Yuil Farm Tech Co., Ltd.
01 12Epinastine hydrochloride
01 1Germany
02 5Italy
03 1Japan
04 2Luxembourg
05 3South Korea
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2014-04-24
Registration Number : 20140327-194-I-378-04(1)
Manufacturer Name : Excella GmbH & Co. KG
Manufacturer Address : Nurnberger Str. 12 90537 Feucht, Germany
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2014-03-27
Registration Number : 20140327-194-I-378-04
Manufacturer Name : Excella GmbH & Co. KG
Manufacturer Address : Nurnberger Str. 12 90537 Feucht, Germany
Registrant Name : Jeil Pharmtech Co., Ltd.
Registration Date : 2013-07-31
Registration Number : 20130731-194-I-355-03
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo (MB) - Via Delle Arti, 33, Italy.
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2019-05-27
Registration Number : 20130731-194-I-355-03(6)
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo(MB)-Via Delle Arti,33,Italy
Registrant Name : Donggu Biopharmaceutical Co., Ltd.
Registration Date : 2014-02-18
Registration Number : 20130731-194-I-355-03(1)
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo (MB) - Via Delle Arti, 33, Italy.
Registrant Name : Colmar Pharma Co., Ltd.
Registration Date : 2016-05-17
Registration Number : 20130731-194-I-355-03(4)
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo (MB) - Via Delle Arti, 33, Italy.
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2016-04-26
Registration Number : 20130731-194-I-355-03(5)
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo (MB) - Via Delle Arti. 33. Italy.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2015-04-15
Registration Number : 20150415-194-I-466-05
Manufacturer Name : Hubei Haosun Pharmaceutical ...
Manufacturer Address : 8 , Balan Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ No.20 Jux...
Registrant Name : Pharmacostec Co., Ltd.
Registration Date : 2018-05-16
Registration Number : 20180516-194-I-554-06
Manufacturer Name : Pharmacostec Co., Ltd.
Manufacturer Address : Block 35-2, Balan Local Industrial Complex, 47, Pharmaceutical Complex, Hyangnam-eup,...
Registrant Name : Yuil Farm Tech Co., Ltd.
Registration Date : 2021-09-16
Registration Number : 20210916-194-I-625-07
Manufacturer Name : Yuil Farm Tech Co., Ltd.
Manufacturer Address : 3 Mulmi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do
A Epinastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epinastine, including repackagers and relabelers. The FDA regulates Epinastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epinastine 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 Epinastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epinastine supplier is an individual or a company that provides Epinastine active pharmaceutical ingredient (API) or Epinastine finished formulations upon request. The Epinastine suppliers may include Epinastine API manufacturers, exporters, distributors and traders.
click here to find a list of Epinastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Epinastine Drug Master File in Korea (Epinastine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epinastine. The MFDS reviews the Epinastine KDMF as part of the drug registration process and uses the information provided in the Epinastine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epinastine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Epinastine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epinastine suppliers with KDMF on PharmaCompass.
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