01 1Bal Pharma Limited
02 1ESTECHPHARMA CO. , LTD.
03 1Polaris AI Pharma Corp.
04 1Ranke Quimica S. A.
01 2EBASTINE
02 1Ebastine
03 1Japanese Pharmacopoeia ebastine
01 1India
02 2South Korea
03 1Spain
Registration Number : 221MF10107
Registrant's Address : General Miter, 151, 08022 Barcelona, Spain
Initial Date of Registration : 2009-06-02
Latest Date of Registration : 2017-04-19
Japanese Pharmacopoeia Ebastine
Registration Number : 227MF10209
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2015-08-11
Latest Date of Registration : 2015-08-11
Registration Number : 227MF10114
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2015-04-21
Latest Date of Registration : 2015-04-21
Registration Number : 219MF10038
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2007-02-13
Latest Date of Registration : 2007-02-13
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PharmaCompass offers a list of Ebastine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ebastine manufacturer or Ebastine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ebastine manufacturer or Ebastine supplier.
PharmaCompass also assists you with knowing the Ebastine API Price utilized in the formulation of products. Ebastine API Price is not always fixed or binding as the Ebastine Price is obtained through a variety of data sources. The Ebastine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ebastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebastine, including repackagers and relabelers. The FDA regulates Ebastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebastine 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 Ebastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ebastine supplier is an individual or a company that provides Ebastine active pharmaceutical ingredient (API) or Ebastine finished formulations upon request. The Ebastine suppliers may include Ebastine API manufacturers, exporters, distributors and traders.
click here to find a list of Ebastine 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 Ebastine Drug Master File in Japan (Ebastine JDMF) empowers Ebastine 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 Ebastine JDMF during the approval evaluation for pharmaceutical products. At the time of Ebastine 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 Ebastine suppliers with JDMF on PharmaCompass.
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