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  • TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

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

click here to find a list of Levocetirizine suppliers with USDMF 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 KDMF

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

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

After submitting a Levocetirizine 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 Levocetirizine API can apply through the Korea Drug Master File (KDMF).

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

Levocetirizine WC

A Levocetirizine written confirmation (Levocetirizine WC) is an official document issued by a regulatory agency to a Levocetirizine manufacturer, verifying that the manufacturing facility of a Levocetirizine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levocetirizine APIs or Levocetirizine finished pharmaceutical products to another nation, regulatory agencies frequently require a Levocetirizine WC (written confirmation) as part of the regulatory process.

click here to find a list of Levocetirizine suppliers with Written Confirmation (WC) on PharmaCompass.

Levocetirizine NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Levocetirizine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Levocetirizine API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Levocetirizine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Levocetirizine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levocetirizine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Levocetirizine suppliers with NDC on PharmaCompass.

Levocetirizine GMP

Levocetirizine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Levocetirizine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Levocetirizine GMP manufacturer or Levocetirizine GMP API supplier for your needs.

Levocetirizine CoA

A Levocetirizine CoA (Certificate of Analysis) is a formal document that attests to Levocetirizine's compliance with Levocetirizine specifications and serves as a tool for batch-level quality control.

Levocetirizine CoA mostly includes findings from lab analyses of a specific batch. For each Levocetirizine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Levocetirizine may be tested according to a variety of international standards, such as European Pharmacopoeia (Levocetirizine EP), Levocetirizine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levocetirizine USP).

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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