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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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Nanjing Well Pharmaceutical
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Parenteral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.
Solubilizers
Film Formers & Plasticizers
Emulsifying Agents
Thickeners and Stabilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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APIs
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15 Sep 2018
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ABOUT THIS PAGE
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PharmaCompass offers a list of Phenobarbital Sodium 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 Phenobarbital Sodium manufacturer or Phenobarbital Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenobarbital Sodium manufacturer or Phenobarbital Sodium supplier.
PharmaCompass also assists you with knowing the Phenobarbital Sodium API Price utilized in the formulation of products. Phenobarbital Sodium API Price is not always fixed or binding as the Phenobarbital Sodium Price is obtained through a variety of data sources. The Phenobarbital Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Luminal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Luminal, including repackagers and relabelers. The FDA regulates Luminal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Luminal 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 Luminal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Luminal supplier is an individual or a company that provides Luminal active pharmaceutical ingredient (API) or Luminal finished formulations upon request. The Luminal suppliers may include Luminal API manufacturers, exporters, distributors and traders.
click here to find a list of Luminal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Luminal DMF (Drug Master File) is a document detailing the whole manufacturing process of Luminal active pharmaceutical ingredient (API) in detail. Different forms of Luminal DMFs exist exist since differing nations have different regulations, such as Luminal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Luminal DMF submitted to regulatory agencies in the US is known as a USDMF. Luminal USDMF includes data on Luminal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Luminal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Luminal 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 Luminal Drug Master File in Japan (Luminal JDMF) empowers Luminal 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 Luminal JDMF during the approval evaluation for pharmaceutical products. At the time of Luminal 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 Luminal suppliers with JDMF on PharmaCompass.
A Luminal CEP of the European Pharmacopoeia monograph is often referred to as a Luminal Certificate of Suitability (COS). The purpose of a Luminal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Luminal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Luminal to their clients by showing that a Luminal CEP has been issued for it. The manufacturer submits a Luminal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Luminal CEP holder for the record. Additionally, the data presented in the Luminal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Luminal DMF.
A Luminal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Luminal 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 Luminal suppliers with CEP (COS) on PharmaCompass.
A Luminal written confirmation (Luminal WC) is an official document issued by a regulatory agency to a Luminal manufacturer, verifying that the manufacturing facility of a Luminal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Luminal APIs or Luminal finished pharmaceutical products to another nation, regulatory agencies frequently require a Luminal WC (written confirmation) as part of the regulatory process.
click here to find a list of Luminal 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 Luminal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Luminal 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 Luminal 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 Luminal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Luminal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Luminal suppliers with NDC on PharmaCompass.
Luminal 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 Luminal 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 Luminal GMP manufacturer or Luminal GMP API supplier for your needs.
A Luminal CoA (Certificate of Analysis) is a formal document that attests to Luminal's compliance with Luminal specifications and serves as a tool for batch-level quality control.
Luminal CoA mostly includes findings from lab analyses of a specific batch. For each Luminal 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.
Luminal may be tested according to a variety of international standards, such as European Pharmacopoeia (Luminal EP), Luminal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Luminal USP).
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