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DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50065
DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50168
DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50218
DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;E...DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50417
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 10,000 U...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50567
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PharmaCompass offers a list of Polymyxin B Sulfate 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 Polymyxin B Sulfate manufacturer or Polymyxin B Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polymyxin B Sulfate manufacturer or Polymyxin B Sulfate supplier.
PharmaCompass also assists you with knowing the Polymyxin B Sulfate API Price utilized in the formulation of products. Polymyxin B Sulfate API Price is not always fixed or binding as the Polymyxin B Sulfate Price is obtained through a variety of data sources. The Polymyxin B Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Polymyxin B Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polymyxin B Sulfate, including repackagers and relabelers. The FDA regulates Polymyxin B Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polymyxin B Sulfate 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 Polymyxin B Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polymyxin B Sulfate supplier is an individual or a company that provides Polymyxin B Sulfate active pharmaceutical ingredient (API) or Polymyxin B Sulfate finished formulations upon request. The Polymyxin B Sulfate suppliers may include Polymyxin B Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Polymyxin B Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polymyxin B Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Polymyxin B Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Polymyxin B Sulfate DMFs exist exist since differing nations have different regulations, such as Polymyxin B Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polymyxin B Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Polymyxin B Sulfate USDMF includes data on Polymyxin B Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polymyxin B Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polymyxin B Sulfate 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 Polymyxin B Sulfate Drug Master File in Japan (Polymyxin B Sulfate JDMF) empowers Polymyxin B Sulfate 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 Polymyxin B Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Polymyxin B Sulfate 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 Polymyxin B Sulfate suppliers with JDMF 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 Polymyxin B Sulfate Drug Master File in Korea (Polymyxin B Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Polymyxin B Sulfate. The MFDS reviews the Polymyxin B Sulfate KDMF as part of the drug registration process and uses the information provided in the Polymyxin B Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Polymyxin B Sulfate 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 Polymyxin B Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Polymyxin B Sulfate suppliers with KDMF on PharmaCompass.
A Polymyxin B Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Polymyxin B Sulfate Certificate of Suitability (COS). The purpose of a Polymyxin B Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Polymyxin B Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Polymyxin B Sulfate to their clients by showing that a Polymyxin B Sulfate CEP has been issued for it. The manufacturer submits a Polymyxin B Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Polymyxin B Sulfate CEP holder for the record. Additionally, the data presented in the Polymyxin B Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Polymyxin B Sulfate DMF.
A Polymyxin B Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Polymyxin B Sulfate 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 Polymyxin B Sulfate suppliers with CEP (COS) on PharmaCompass.
A Polymyxin B Sulfate written confirmation (Polymyxin B Sulfate WC) is an official document issued by a regulatory agency to a Polymyxin B Sulfate manufacturer, verifying that the manufacturing facility of a Polymyxin B Sulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Polymyxin B Sulfate APIs or Polymyxin B Sulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Polymyxin B Sulfate WC (written confirmation) as part of the regulatory process.
click here to find a list of Polymyxin B Sulfate 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 Polymyxin B Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Polymyxin B Sulfate 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 Polymyxin B Sulfate 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 Polymyxin B Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Polymyxin B Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Polymyxin B Sulfate suppliers with NDC on PharmaCompass.
Polymyxin B Sulfate 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 Polymyxin B Sulfate 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 Polymyxin B Sulfate GMP manufacturer or Polymyxin B Sulfate GMP API supplier for your needs.
A Polymyxin B Sulfate CoA (Certificate of Analysis) is a formal document that attests to Polymyxin B Sulfate's compliance with Polymyxin B Sulfate specifications and serves as a tool for batch-level quality control.
Polymyxin B Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Polymyxin B Sulfate 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.
Polymyxin B Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Polymyxin B Sulfate EP), Polymyxin B Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polymyxin B Sulfate USP).
