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**Federal...DOSAGE - CREAM;TOPICAL - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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