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KDMF
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DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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DOSAGE - OINTMENT;NASAL - EQ 2% BASE
USFDA APPLICATION NUMBER - 50703
DOSAGE - CREAM;TOPICAL - EQ 2% BASE **Federal...DOSAGE - CREAM;TOPICAL - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50746
Related Excipient Companies
Rochem International Inc
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Co-Processed Excipients
Thickeners and Stabilizers
Solubilizers
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Mupirocin Calcium 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 Mupirocin Calcium manufacturer or Mupirocin Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mupirocin Calcium manufacturer or Mupirocin Calcium supplier.
PharmaCompass also assists you with knowing the Mupirocin Calcium API Price utilized in the formulation of products. Mupirocin Calcium API Price is not always fixed or binding as the Mupirocin Calcium Price is obtained through a variety of data sources. The Mupirocin Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Turixin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Turixin, including repackagers and relabelers. The FDA regulates Turixin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Turixin 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 Turixin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Turixin supplier is an individual or a company that provides Turixin active pharmaceutical ingredient (API) or Turixin finished formulations upon request. The Turixin suppliers may include Turixin API manufacturers, exporters, distributors and traders.
click here to find a list of Turixin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Turixin DMF (Drug Master File) is a document detailing the whole manufacturing process of Turixin active pharmaceutical ingredient (API) in detail. Different forms of Turixin DMFs exist exist since differing nations have different regulations, such as Turixin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Turixin DMF submitted to regulatory agencies in the US is known as a USDMF. Turixin USDMF includes data on Turixin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Turixin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Turixin suppliers with USDMF on PharmaCompass.
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 Turixin Drug Master File in Japan (Turixin JDMF) empowers Turixin 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 Turixin JDMF during the approval evaluation for pharmaceutical products. At the time of Turixin 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 Turixin suppliers with JDMF on PharmaCompass.
A Turixin CEP of the European Pharmacopoeia monograph is often referred to as a Turixin Certificate of Suitability (COS). The purpose of a Turixin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Turixin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Turixin to their clients by showing that a Turixin CEP has been issued for it. The manufacturer submits a Turixin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Turixin CEP holder for the record. Additionally, the data presented in the Turixin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Turixin DMF.
A Turixin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Turixin 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 Turixin suppliers with CEP (COS) on PharmaCompass.
A Turixin written confirmation (Turixin WC) is an official document issued by a regulatory agency to a Turixin manufacturer, verifying that the manufacturing facility of a Turixin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Turixin APIs or Turixin finished pharmaceutical products to another nation, regulatory agencies frequently require a Turixin WC (written confirmation) as part of the regulatory process.
click here to find a list of Turixin 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 Turixin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Turixin 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 Turixin 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 Turixin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Turixin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Turixin suppliers with NDC on PharmaCompass.
Turixin 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 Turixin 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 Turixin GMP manufacturer or Turixin GMP API supplier for your needs.
A Turixin CoA (Certificate of Analysis) is a formal document that attests to Turixin's compliance with Turixin specifications and serves as a tool for batch-level quality control.
Turixin CoA mostly includes findings from lab analyses of a specific batch. For each Turixin 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.
Turixin may be tested according to a variety of international standards, such as European Pharmacopoeia (Turixin EP), Turixin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Turixin USP).
