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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Mupirocin 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 manufacturer or Mupirocin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mupirocin manufacturer or Mupirocin supplier.
PharmaCompass also assists you with knowing the Mupirocin API Price utilized in the formulation of products. Mupirocin API Price is not always fixed or binding as the Mupirocin Price is obtained through a variety of data sources. The Mupirocin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bactroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bactroban, including repackagers and relabelers. The FDA regulates Bactroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bactroban 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 Bactroban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bactroban supplier is an individual or a company that provides Bactroban active pharmaceutical ingredient (API) or Bactroban finished formulations upon request. The Bactroban suppliers may include Bactroban API manufacturers, exporters, distributors and traders.
click here to find a list of Bactroban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bactroban DMF (Drug Master File) is a document detailing the whole manufacturing process of Bactroban active pharmaceutical ingredient (API) in detail. Different forms of Bactroban DMFs exist exist since differing nations have different regulations, such as Bactroban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bactroban DMF submitted to regulatory agencies in the US is known as a USDMF. Bactroban USDMF includes data on Bactroban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bactroban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bactroban suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bactroban Drug Master File in Korea (Bactroban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bactroban. The MFDS reviews the Bactroban KDMF as part of the drug registration process and uses the information provided in the Bactroban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bactroban 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 Bactroban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bactroban suppliers with KDMF on PharmaCompass.
A Bactroban CEP of the European Pharmacopoeia monograph is often referred to as a Bactroban Certificate of Suitability (COS). The purpose of a Bactroban CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bactroban EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bactroban to their clients by showing that a Bactroban CEP has been issued for it. The manufacturer submits a Bactroban CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bactroban CEP holder for the record. Additionally, the data presented in the Bactroban CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bactroban DMF.
A Bactroban CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bactroban 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 Bactroban suppliers with CEP (COS) on PharmaCompass.
A Bactroban written confirmation (Bactroban WC) is an official document issued by a regulatory agency to a Bactroban manufacturer, verifying that the manufacturing facility of a Bactroban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bactroban APIs or Bactroban finished pharmaceutical products to another nation, regulatory agencies frequently require a Bactroban WC (written confirmation) as part of the regulatory process.
click here to find a list of Bactroban 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 Bactroban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bactroban 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 Bactroban 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 Bactroban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bactroban NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bactroban suppliers with NDC on PharmaCompass.
Bactroban 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 Bactroban 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 Bactroban GMP manufacturer or Bactroban GMP API supplier for your needs.
A Bactroban CoA (Certificate of Analysis) is a formal document that attests to Bactroban's compliance with Bactroban specifications and serves as a tool for batch-level quality control.
Bactroban CoA mostly includes findings from lab analyses of a specific batch. For each Bactroban 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.
Bactroban may be tested according to a variety of international standards, such as European Pharmacopoeia (Bactroban EP), Bactroban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bactroban USP).
