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
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PharmaCompass offers a list of Ketotifen Fumarate 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 Ketotifen Fumarate manufacturer or Ketotifen Fumarate supplier for your needs.
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PharmaCompass also assists you with knowing the Ketotifen Fumarate API Price utilized in the formulation of products. Ketotifen Fumarate API Price is not always fixed or binding as the Ketotifen Fumarate Price is obtained through a variety of data sources. The Ketotifen Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ketotifen fumerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen fumerate, including repackagers and relabelers. The FDA regulates Ketotifen fumerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen fumerate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ketotifen fumerate supplier is an individual or a company that provides Ketotifen fumerate active pharmaceutical ingredient (API) or Ketotifen fumerate finished formulations upon request. The Ketotifen fumerate suppliers may include Ketotifen fumerate API manufacturers, exporters, distributors and traders.
click here to find a list of Ketotifen fumerate 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 fumerate Drug Master File in Japan (Ketotifen fumerate JDMF) empowers Ketotifen fumerate 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 fumerate JDMF during the approval evaluation for pharmaceutical products. At the time of Ketotifen fumerate 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 fumerate suppliers with JDMF on PharmaCompass.
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