Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 1Bal Pharma Limited
02 1ESTECHPHARMA CO. , LTD.
03 1Polaris AI Pharma Corp.
04 1Ranke Quimica S. A.
05 1Sanyo Chemical Research Institute Co., Ltd.
01 2EBASTINE
02 2Ebastine
03 1Japanese Pharmacopoeia ebastine
01 1Gabon
02 1India
03 2South Korea
04 1Spain
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
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 : 221MF10107
Registrant's Address : General Miter, 151, 08022 Barcelona, Spain
Initial Date of Registration : 2009-06-02
Latest Date of Registration : 2017-04-19
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
Registration Number : 218MF10851
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2006-10-20
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.
We have 3 companies offering Ebastine
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