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List of Japan Drug Master File (JDMF) for Fexofenadine Hydrochloride Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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  • SUSPENSION;ORAL - 30MG/5ML
  • TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
  • TABLET;ORAL - 180MG
  • TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 60MG
  • TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
  • TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
  • SUSPENSION;ORAL - 30MG/5ML

Looking for 153439-40-8 / Fexofenadine Hydrochloride API manufacturers, exporters & distributors?

Fexofenadine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Fexofenadine Hydrochloride 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 Fexofenadine Hydrochloride manufacturer or Fexofenadine Hydrochloride supplier for your needs.

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

PharmaCompass also assists you with knowing the Fexofenadine Hydrochloride API Price utilized in the formulation of products. Fexofenadine Hydrochloride API Price is not always fixed or binding as the Fexofenadine Hydrochloride Price is obtained through a variety of data sources. The Fexofenadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fexofenadine Hydrochloride

Synonyms

153439-40-8, Fexofenadine hcl, Allegra, Telfast, 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride, Mdl 16,455a

Cas Number

153439-40-8

Unique Ingredient Identifier (UNII)

2S068B75ZU

About Fexofenadine Hydrochloride

Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine, a carboxylated metabolic derivative of terfenadine and second generation, long-lasting selective histamine H1 receptor antagonist, with antihistaminic activity. Upon administration, fexofenadine competitively binds of peripheral H1-receptors in the gastrointestinal (GI) tract, blood vessels, and bronchial smooth muscle. This prevents binding of histamine to peripheral H1-receptors and prevents their activation. This prevents a histamine-mediated allergic reaction. Fexofenadine does not cross the blood-brain-barrier (BBB).

Fexofenadine Hydrochloride Manufacturers

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

Fexofenadine Hydrochloride Suppliers

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

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

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

Fexofenadine Hydrochloride Manufacturers | Traders | Suppliers

Fexofenadine Hydrochloride Manufacturers, Traders, Suppliers 1
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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