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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21497
DOSAGE - FOR SUSPENSION;ORAL - 100MG/5ML
USFDA APPLICATION NUMBER - 21498
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
32
PharmaCompass offers a list of Nitazoxanide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nitazoxanide manufacturer or Nitazoxanide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitazoxanide manufacturer or Nitazoxanide supplier.
A Celectan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Celectan, including repackagers and relabelers. The FDA regulates Celectan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Celectan 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 Celectan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Celectan supplier is an individual or a company that provides Celectan active pharmaceutical ingredient (API) or Celectan finished formulations upon request. The Celectan suppliers may include Celectan API manufacturers, exporters, distributors and traders.
click here to find a list of Celectan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Celectan DMF (Drug Master File) is a document detailing the whole manufacturing process of Celectan active pharmaceutical ingredient (API) in detail. Different forms of Celectan DMFs exist exist since differing nations have different regulations, such as Celectan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Celectan DMF submitted to regulatory agencies in the US is known as a USDMF. Celectan USDMF includes data on Celectan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Celectan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Celectan suppliers with USDMF on PharmaCompass.
A Celectan written confirmation (Celectan WC) is an official document issued by a regulatory agency to a Celectan manufacturer, verifying that the manufacturing facility of a Celectan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Celectan APIs or Celectan finished pharmaceutical products to another nation, regulatory agencies frequently require a Celectan WC (written confirmation) as part of the regulatory process.
click here to find a list of Celectan suppliers with Written Confirmation (WC) on PharmaCompass.
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 Celectan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Celectan API and other APIs are published in this directory by the FDA.
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 Celectan 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.
The NDC directory also contains data on finished compounded human drug products that contain Celectan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Celectan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Celectan suppliers with NDC on PharmaCompass.
Celectan 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 Celectan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Celectan GMP manufacturer or Celectan GMP API supplier for your needs.
A Celectan CoA (Certificate of Analysis) is a formal document that attests to Celectan's compliance with Celectan specifications and serves as a tool for batch-level quality control.
Celectan CoA mostly includes findings from lab analyses of a specific batch. For each Celectan 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.
Celectan may be tested according to a variety of international standards, such as European Pharmacopoeia (Celectan EP), Celectan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Celectan USP).
