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List of Drug Master Files (KDMF) for Ketotifen Fumarate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Fleming Laboratories Limited (1)

02 Novartis ringaskiddy ltd (1)

03 Olon SpA (2)

04 Zhejiang Huahai Pharmaceutical co., ltd (1)

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01 Eltech Pharmachem Co., Ltd. (1)

02 Samil Pharmaceutical Co., Ltd. (1)

03 Samo Pharmaceutical Co., Ltd. (1)

04 Sungwoo Chemical Co., Ltd. (1)

05 Unimed Pharmaceutical Co., Ltd. (1)

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01 Ketotifen fumarate (5)

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01 China (1)

02 India (1)

03 Italy (2)

04 Switzerland (1)

URL Supplier Web Content
Eltech Pharmachem Co., Ltd.
2021-11-23
20211123-92-E-165-04
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Samil Pharmaceutical Co., Ltd.
2007-12-06
20071204-92-E-49-01
Novartis ringaskiddy ltd
Ireland
Ringaskiddy, Country Cork...
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Unimed Pharmaceutical Co., Ltd.
2011-10-07
20080228-92-E-44-02(1)
Olon SpA
Italy
Via Livelli 1, Frazione M...
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Samo Pharmaceutical Co., Ltd.
2008-02-29
20080228-92-E-44-02
Olon SpA
Italy
Via Livelli 1, Frazione M...
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Sungwoo Chemical Co., Ltd.
2008-06-27
20080627-92-E-71-03
Zhejiang Huahai Pharmaceu...
China
Linhai 317024, Zhejiang
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Ketotifen Fumarate Drug Master File in Korea (Ketotifen Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ketotifen Fumarate. The MFDS reviews the Ketotifen Fumarate KDMF as part of the drug registration process and uses the information provided in the Ketotifen Fumarate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Ketotifen Fumarate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ketotifen Fumarate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ketotifen Fumarate suppliers with KDMF on PharmaCompass.

Ketotifen Fumarate Manufacturers | Traders | Suppliers

Ketotifen Fumarate Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Ketotifen Fumarate

Get in contact with the supplier of your choice:

  1. Fleming Laboratories
  2. Novartis Pharmaceuticals Corporation
  3. Olon S.p.A
  4. 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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