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USDMF
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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**Federal...DOSAGE - CREAM;TOPICAL - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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 Mupirocin Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mupirocin Calcium, including repackagers and relabelers. The FDA regulates Mupirocin Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mupirocin Calcium 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 Mupirocin Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mupirocin Calcium supplier is an individual or a company that provides Mupirocin Calcium active pharmaceutical ingredient (API) or Mupirocin Calcium finished formulations upon request. The Mupirocin Calcium suppliers may include Mupirocin Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Mupirocin Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mupirocin Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mupirocin Calcium active pharmaceutical ingredient (API) in detail. Different forms of Mupirocin Calcium DMFs exist exist since differing nations have different regulations, such as Mupirocin Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mupirocin Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Mupirocin Calcium USDMF includes data on Mupirocin Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mupirocin Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mupirocin Calcium 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 Mupirocin Calcium Drug Master File in Japan (Mupirocin Calcium JDMF) empowers Mupirocin Calcium 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 Mupirocin Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Mupirocin Calcium 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 Mupirocin Calcium suppliers with JDMF on PharmaCompass.
A Mupirocin Calcium CEP of the European Pharmacopoeia monograph is often referred to as a Mupirocin Calcium Certificate of Suitability (COS). The purpose of a Mupirocin Calcium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mupirocin Calcium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mupirocin Calcium to their clients by showing that a Mupirocin Calcium CEP has been issued for it. The manufacturer submits a Mupirocin Calcium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mupirocin Calcium CEP holder for the record. Additionally, the data presented in the Mupirocin Calcium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mupirocin Calcium DMF.
A Mupirocin Calcium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mupirocin Calcium 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 Mupirocin Calcium suppliers with CEP (COS) on PharmaCompass.
A Mupirocin Calcium written confirmation (Mupirocin Calcium WC) is an official document issued by a regulatory agency to a Mupirocin Calcium manufacturer, verifying that the manufacturing facility of a Mupirocin Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mupirocin Calcium APIs or Mupirocin Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Mupirocin Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Mupirocin Calcium 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 Mupirocin Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mupirocin Calcium 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 Mupirocin Calcium 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 Mupirocin Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mupirocin Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mupirocin Calcium suppliers with NDC on PharmaCompass.
Mupirocin Calcium 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 Mupirocin Calcium 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 Mupirocin Calcium GMP manufacturer or Mupirocin Calcium GMP API supplier for your needs.
A Mupirocin Calcium CoA (Certificate of Analysis) is a formal document that attests to Mupirocin Calcium's compliance with Mupirocin Calcium specifications and serves as a tool for batch-level quality control.
Mupirocin Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Mupirocin Calcium 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.
Mupirocin Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Mupirocin Calcium EP), Mupirocin Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mupirocin Calcium USP).
