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List of Drug Master Files (JDMF) for Ketotifen Fumarate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 LABORATORI ALCHEMIA SRL (1)

02 Olon S. p. A. (1)

03 Zhejiang Huahai Pharmaceutical Co. , Ltd. (1)

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01 "Japan-station" ketotifen fumarate (production only) (1)

02 KETOTIFEN FUMARATE (2)

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01 China (1)

02 Italy (2)

URL Supplier Web Content
219MF10162
Via San Faustino, 68 20134 Milano-I...
2016-05-26
2007-05-15
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218MF10545
Strada Rivoltana Km 6/7 20090 Rodan...
2009-04-14
2006-06-02
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URL Supplier Web Content
217MF10883
Xunqiao, Linhai, Zhejiang 317024, C...
2006-12-18
2005-11-07
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Looking for 34580-14-8 / Ketotifen Fumarate API manufacturers, exporters & distributors?

Ketotifen Fumarate manufacturers, exporters & distributors 1

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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.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketotifen Fumarate manufacturer or Ketotifen Fumarate supplier.

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.

API | Excipient name

Ketotifen Fumarate

Synonyms

34580-14-8, Zaditen, Zaditor, Ketotifen hydrogen fumarate, Alaway, Hc 20,511 fumarate

Cas Number

34580-14-8

Unique Ingredient Identifier (UNII)

HBD503WORO

About Ketotifen Fumarate

A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.

Ketotifen Fumarate Manufacturers

A Ketotifen Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen Fumarate, including repackagers and relabelers. The FDA regulates Ketotifen Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen Fumarate 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 Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ketotifen Fumarate Suppliers

A Ketotifen Fumarate supplier is an individual or a company that provides Ketotifen Fumarate active pharmaceutical ingredient (API) or Ketotifen Fumarate finished formulations upon request. The Ketotifen Fumarate suppliers may include Ketotifen Fumarate API manufacturers, exporters, distributors and traders.

click here to find a list of Ketotifen Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ketotifen Fumarate JDMF

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 Fumarate Drug Master File in Japan (Ketotifen Fumarate JDMF) empowers Ketotifen Fumarate 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 Fumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Ketotifen Fumarate 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 Fumarate suppliers with JDMF on PharmaCompass.

Ketotifen Fumarate Manufacturers | Traders | Suppliers

Ketotifen Fumarate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Ketotifen Fumarate

Get in contact with the supplier of your choice:

  1. Laboratori Alchemia Srl
  2. Sifavitor srl
  3. Zhejiang Huahai Pharmaceutical
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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