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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
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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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
EUROAPI
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
A POLY-RX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of POLY-RX, including repackagers and relabelers. The FDA regulates POLY-RX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. POLY-RX 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 POLY-RX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A POLY-RX supplier is an individual or a company that provides POLY-RX active pharmaceutical ingredient (API) or POLY-RX finished formulations upon request. The POLY-RX suppliers may include POLY-RX API manufacturers, exporters, distributors and traders.
click here to find a list of POLY-RX suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A POLY-RX DMF (Drug Master File) is a document detailing the whole manufacturing process of POLY-RX active pharmaceutical ingredient (API) in detail. Different forms of POLY-RX DMFs exist exist since differing nations have different regulations, such as POLY-RX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A POLY-RX DMF submitted to regulatory agencies in the US is known as a USDMF. POLY-RX USDMF includes data on POLY-RX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The POLY-RX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of POLY-RX 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 POLY-RX Drug Master File in Japan (POLY-RX JDMF) empowers POLY-RX 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 POLY-RX JDMF during the approval evaluation for pharmaceutical products. At the time of POLY-RX 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 POLY-RX 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 POLY-RX Drug Master File in Korea (POLY-RX KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of POLY-RX. The MFDS reviews the POLY-RX KDMF as part of the drug registration process and uses the information provided in the POLY-RX KDMF to evaluate the safety and efficacy of the drug.
After submitting a POLY-RX 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 POLY-RX API can apply through the Korea Drug Master File (KDMF).
click here to find a list of POLY-RX suppliers with KDMF on PharmaCompass.
A POLY-RX CEP of the European Pharmacopoeia monograph is often referred to as a POLY-RX Certificate of Suitability (COS). The purpose of a POLY-RX CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of POLY-RX EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of POLY-RX to their clients by showing that a POLY-RX CEP has been issued for it. The manufacturer submits a POLY-RX CEP (COS) as part of the market authorization procedure, and it takes on the role of a POLY-RX CEP holder for the record. Additionally, the data presented in the POLY-RX CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the POLY-RX DMF.
A POLY-RX CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. POLY-RX 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 POLY-RX suppliers with CEP (COS) on PharmaCompass.
A POLY-RX written confirmation (POLY-RX WC) is an official document issued by a regulatory agency to a POLY-RX manufacturer, verifying that the manufacturing facility of a POLY-RX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting POLY-RX APIs or POLY-RX finished pharmaceutical products to another nation, regulatory agencies frequently require a POLY-RX WC (written confirmation) as part of the regulatory process.
click here to find a list of POLY-RX 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 POLY-RX as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for POLY-RX 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 POLY-RX 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 POLY-RX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a POLY-RX NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of POLY-RX suppliers with NDC on PharmaCompass.
POLY-RX 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 POLY-RX GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right POLY-RX GMP manufacturer or POLY-RX GMP API supplier for your needs.
A POLY-RX CoA (Certificate of Analysis) is a formal document that attests to POLY-RX's compliance with POLY-RX specifications and serves as a tool for batch-level quality control.
POLY-RX CoA mostly includes findings from lab analyses of a specific batch. For each POLY-RX 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.
POLY-RX may be tested according to a variety of international standards, such as European Pharmacopoeia (POLY-RX EP), POLY-RX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (POLY-RX USP).
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