01 1FAES FARMA, S. A.
02 1Lee Pharma Limited
03 1Sai Life Sciences Limited
04 1Sumitomo Chemical Co., Ltd.
01 3Bilastine
02 1Birasuchin
01 2India
02 1Japan
03 1Spain
Registration Number : 306MF10049
Registrant's Address : Ma(´)ximo Aguirre, 14, 48940 Leioa, SPAIN
Initial Date of Registration : 2024-04-03
Latest Date of Registration : 2024-04-03
Registration Number : 303MF10159
Registrant's Address : SY. No. :257 & 258/1, Door No: 11-6/56-C, Opp: IDPL Factory, Moosapet, Balanagar (Pos...
Initial Date of Registration : 2021-10-21
Latest Date of Registration : 2021-10-21
Registration Number : 227MF10243
Registrant's Address : Plot No. DS-7, IKP Knowledge Pk, Turkapally Village, Shameerpet Mandal, Medchal Malka...
Initial Date of Registration : 2015-10-07
Latest Date of Registration : 2023-04-05
Registration Number : 306MF10158
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2024-12-11
Latest Date of Registration : 2024-12-11
A Bilastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilastine, including repackagers and relabelers. The FDA regulates Bilastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilastine 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 Bilastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilastine supplier is an individual or a company that provides Bilastine active pharmaceutical ingredient (API) or Bilastine finished formulations upon request. The Bilastine suppliers may include Bilastine API manufacturers, exporters, distributors and traders.
click here to find a list of Bilastine 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 Bilastine Drug Master File in Japan (Bilastine JDMF) empowers Bilastine 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 Bilastine JDMF during the approval evaluation for pharmaceutical products. At the time of Bilastine 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 Bilastine suppliers with JDMF on PharmaCompass.
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