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DRUG PRODUCT COMPOSITIONS0
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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.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., is a leading manufacturer and supplier of high-quality biological APIs. With GLP labs and WHO-GMP-certified facilities, Fishfa ...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
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Topical
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Topical, Parenteral
Brand Name : Purified Glycerin
Application : Parenteral, Topical
Excipient Details : Purified glycerin is used in topical dosage forms such as creams, lotions, and ointments. It is also used as a solvent in parenteral formulations.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Cream / Lotion / Ointment, Ophthalmic Solution
Grade : Topical, Parenteral
Application : Solubilizers, Topical
Excipient Details : Syntadex 7702 is used as a solubilizer in ophthalmic drug products and in topical formulations such as creams, lotions, and ointments.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Tablet
Grade : Oral, Topical
Brand Name : Sorbitan Stearate (Span 60)
Application : Emulsifying Agents, Solubilizers, Thickeners and Stabilizers, Topical
Excipient Details : Sorbitan stearate (Span 60) is used as an emulsifier, solubilizer, and stabilizer in creams, gels, tablets, etc.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Emulsion
Grade : Topical
Brand Name : Polyoxyl 25 Cetostearyl Ether
Application : Emulsifying Agents, Surfactant & Foaming Agents, Topical
Excipient Details : Cetostearyl alcohol polyoxyethylene (25) ether is used as a surfactant and emulsifying agent in topical formulations, mainly in emulsions.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Thickeners and Stabilizers, Topical
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Suspension
Grade : Topical
Application : Emulsifying Agents, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 60 is used as a solubilizer, wetting agent, surfactant, emulsifier & stabilizer in topical dosage forms such as creams, suspensions, etc.
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Controlled & Modified Release
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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).
