01 1Boehringer Ingelheim Pharma GmbH & Co. K.G.
02 2DNP Fine Chemicals Utsunomiya Co., Ltd.
03 1Daito Co., Ltd.
04 2Daiwa Pharmaceutical Industries Co., Ltd.
05 1Hubei Haosun Pharmaceutical Co. , Ltd.
06 1IcromS. r. l.
07 4JEIL PHARMACEUTICAL CO. , LTD.
08 1Permakem Asia Co., Ltd.
09 2Pharmacostech CO. ,LTD
10 1Sanyo Chemical Research Institute Co., Ltd.
11 1UK Chemipharm Co. , Ltd.
12 1YUIL PHARM TECH. C.O. , LTD.
01 2Epinastine Hydrochloride
02 8Epinastine hydrochloride
03 1Epinastine hydrochloride "Sanyo"
04 1Epinastine hydrochloride (C) (production only)
05 1Epinastine hydrochloride (for manufacturing use only)
06 2Epinastine hydrochloride (production only)
07 3epinastine hydrochloride
01 1China
02 1Egypt
03 1Gabon
04 1Germany
05 1India
06 1Italy
07 6Japan
08 6South Korea
Registration Number : 224MF10100
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2012-05-23
Latest Date of Registration : 2017-10-06
Epinastine hydrochloride (for manufacturing purposes only)
Registration Number : 226MF10049
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2014-02-27
Latest Date of Registration : 2014-02-27
Epinastine hydrochloride (for manufacturing purposes only)
Registration Number : 305MF10001
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2023-01-11
Latest Date of Registration : 2023-10-04
Epinastine hydrochloride (for manufacturing purposes only)
Registration Number : 221MF10218
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2009-10-07
Latest Date of Registration : 2023-06-14
Registration Number : 227MF10217
Registrant's Address : No. 20 Juxian Road, Gedian Economic & Technology Development Area, Hubei, 436070, P. ...
Initial Date of Registration : 2015-08-31
Latest Date of Registration : 2015-08-31
Registration Number : 226MF10231
Registrant's Address : Via Delle Arti 33, 20863 Concorezzo (MB), Italy
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2020-06-11
Registration Number : 302MF10108
Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea
Initial Date of Registration : 2020-09-08
Latest Date of Registration : 2020-09-08
Registration Number : 302MF10008
Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea
Initial Date of Registration : 2020-01-10
Latest Date of Registration : 2020-01-10
Epinastine hydrochloride (C) (for manufacturing purposes only)
Registration Number : 229MF10196
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2017-11-07
Latest Date of Registration : 2017-11-07
Registration Number : 303MF10009
Registrant's Address : 3, Mulmi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do, Republic of Korea
Initial Date of Registration : 2021-01-20
Latest Date of Registration : 2021-01-20
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.
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 Epinastine Drug Master File in Japan (Epinastine JDMF) empowers Epinastine 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 Epinastine JDMF during the approval evaluation for pharmaceutical products. At the time of Epinastine 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 Epinastine suppliers with JDMF on PharmaCompass.
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