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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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