01 1Janssen Pharmaceutica NV
02 2Katsura Chemical Co., Ltd.
01 1Levocabastine Hydrochloride-K
02 2Levocabastine hydrochloride
01 2Japan
02 1U.S.A
Registration Number : 228MF10206
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2016-11-02
Latest Date of Registration : 2016-11-02
Registration Number : 230MF10168
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2018-12-19
Latest Date of Registration : 2018-12-19
Registration Number : 218MF10995
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2008-11-25
A LEVOCABASTINE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LEVOCABASTINE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates LEVOCABASTINE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LEVOCABASTINE HYDROCHLORIDE 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 LEVOCABASTINE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LEVOCABASTINE HYDROCHLORIDE supplier is an individual or a company that provides LEVOCABASTINE HYDROCHLORIDE active pharmaceutical ingredient (API) or LEVOCABASTINE HYDROCHLORIDE finished formulations upon request. The LEVOCABASTINE HYDROCHLORIDE suppliers may include LEVOCABASTINE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of LEVOCABASTINE HYDROCHLORIDE 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 LEVOCABASTINE HYDROCHLORIDE Drug Master File in Japan (LEVOCABASTINE HYDROCHLORIDE JDMF) empowers LEVOCABASTINE HYDROCHLORIDE 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 LEVOCABASTINE HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of LEVOCABASTINE HYDROCHLORIDE 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 LEVOCABASTINE HYDROCHLORIDE suppliers with JDMF on PharmaCompass.
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