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

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302MF10110
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  • SOLUTION;ORAL - 2.5MG/5ML
  • TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 130018-87-0 / Levocetirizine Dihydrochloride API manufacturers, exporters & distributors?

Levocetirizine Dihydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier for your needs.

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

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

API | Excipient name

Levocetirizine Dihydrochloride

Synonyms

130018-87-0, Xyzal, Xusal, (r)-cetirizine dihydrochloride, Levocetirizine hcl, Levocetirizine dihydrochloride [usan]

Cas Number

130018-87-0

Unique Ingredient Identifier (UNII)

SOD6A38AGA

About Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride is the dihydrochloride salt form of the active levorotatory enantiomer of cetirizine, levocetirizine; a third generation, non-sedating, selective histamine H1 receptor antagonist, with antihistamine, anti-inflammatory and potential anti-angiogenic activities. Levocetirizine competes with endogenous histamine for binding at peripheral H1-receptor sites on the effector cell surface. This prevents the negative symptoms associated with histamine release and an allergic reaction. In addition, as histamine plays an important role in angiogenesis during an allergic inflammatory reaction, blocking the action of histamine may modulate the expression of proangiogenic factors and thus may prevent angiogenesis. As a third-generation histamine H1 receptor antagonist, levocetirizine has fewer side effects than most second-generation antihistamines.

Levocetirizine Manufacturers

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

Levocetirizine Suppliers

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

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

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

Levocetirizine Manufacturers | Traders | Suppliers

Levocetirizine Manufacturers, Traders, Suppliers 1
63

We have 4 companies offering Levocetirizine

Get in contact with the supplier of your choice:

  1. Metrochem API Private Limited
  2. IWAKI SEIYAKU
  3. Sato Yakuhin Kogyo Co., Ltd
  4. Yoshindo
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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