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List of Drug Master Files (DMF) of Ketotifen Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Quimica Sintetica S.A. (1)

02 Sifavitor srl (2)

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01 KETOTIFEN (1)

02 KETOTIFEN FUMERATE (1)

03 KETOTIFEN HYDROGEN FUMARATE (1)

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01 Italy (2)

02 Spain (1)

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01 Active (1)

02 Inactive (2)

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01 Complete (1)

02 Blank (2)

URL Supplier Web Content
9440
Inactive
1991-11-11
N/A
II
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URL Supplier Web Content
16201
Active
2002-10-14
Complete
2015-02-22
2015-02-13
II
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URL Supplier Web Content
21687
Inactive
2008-06-11
N/A
II
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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 Manufacturers

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.

Ketotifen Suppliers

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.

Ketotifen USDMF

A Ketotifen DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketotifen active pharmaceutical ingredient (API) in detail. Different forms of Ketotifen DMFs exist exist since differing nations have different regulations, such as Ketotifen USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ketotifen DMF submitted to regulatory agencies in the US is known as a USDMF. Ketotifen USDMF includes data on Ketotifen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketotifen USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

Ketotifen Manufacturers | Traders | Suppliers

Ketotifen Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Ketotifen

Get in contact with the supplier of your choice:

  1. Quimica Sintetica S.A.
  2. Sifavitor srl
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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