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  • TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 81103-11-9 / Clarithromycin API manufacturers, exporters & distributors?

Clarithromycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Clarithromycin

Synonyms

81103-11-9, Biaxin, 6-o-methylerythromycin, Klaricid, 6-o-methylerythromycin a, Abbott-56268

Cas Number

81103-11-9

Unique Ingredient Identifier (UNII)

H1250JIK0A

About Clarithromycin

A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.

Prevpac Manufacturers

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

Prevpac Suppliers

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

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

Prevpac USDMF

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

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

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

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

Prevpac KDMF

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

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

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

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

Prevpac CEP

A Prevpac CEP of the European Pharmacopoeia monograph is often referred to as a Prevpac Certificate of Suitability (COS). The purpose of a Prevpac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prevpac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prevpac to their clients by showing that a Prevpac CEP has been issued for it. The manufacturer submits a Prevpac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prevpac CEP holder for the record. Additionally, the data presented in the Prevpac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prevpac DMF.

A Prevpac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prevpac CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Prevpac suppliers with CEP (COS) on PharmaCompass.

Prevpac WC

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

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

Prevpac 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 Prevpac as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Prevpac 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 Prevpac 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 Prevpac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prevpac NDC to their finished compounded human drug products, they may choose to do so.

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

Prevpac GMP

Prevpac 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 Prevpac 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 Prevpac GMP manufacturer or Prevpac GMP API supplier for your needs.

Prevpac CoA

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

Prevpac CoA mostly includes findings from lab analyses of a specific batch. For each Prevpac 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.

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