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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocabastine, including repackagers and relabelers. The FDA regulates Levocabastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocabastine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocabastine supplier is an individual or a company that provides Levocabastine active pharmaceutical ingredient (API) or Levocabastine finished formulations upon request. The Levocabastine suppliers may include Levocabastine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocabastine 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 Drug Master File in Japan (Levocabastine JDMF) empowers Levocabastine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Levocabastine 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 suppliers with JDMF on PharmaCompass.
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