01 1LABORATORI ALCHEMIA SRL
02 1Olon S. p. A.
03 1Zhejiang Huahai Pharmaceutical Co. , Ltd.
01 1"Japan-station" ketotifen fumarate (production only)
02 2KETOTIFEN FUMARATE
01 1China
02 2Italy
Registration Number : 219MF10162
Registrant's Address : Via San Faustino, 68 20134 Milano-Italy
Initial Date of Registration : 2007-05-15
Latest Date of Registration : 2016-05-26
Registration Number : 218MF10545
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2024-08-22
"JP" Ketotifen Fumarate (for manufacturing purposes only)
Registration Number : 217MF10883
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2006-12-18
A Ketotifen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen, including repackagers and relabelers. The FDA regulates Ketotifen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen 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 Ketotifen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketotifen supplier is an individual or a company that provides Ketotifen active pharmaceutical ingredient (API) or Ketotifen finished formulations upon request. The Ketotifen suppliers may include Ketotifen API manufacturers, exporters, distributors and traders.
click here to find a list of Ketotifen 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 Ketotifen Drug Master File in Japan (Ketotifen JDMF) empowers Ketotifen 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 Ketotifen JDMF during the approval evaluation for pharmaceutical products. At the time of Ketotifen 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 Ketotifen suppliers with JDMF on PharmaCompass.
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