Synopsis
0
CEP/COS
0
EU WC
0
VMF
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Solubilizers
Topical
Parenteral
Thickeners and Stabilizers
Emulsifying Agents
Film Formers & Plasticizers
Rheology Modifiers
API Stability Enhancers
Surfactant & Foaming Agents
Controlled & Modified Release
Direct Compression
Co-Processed Excipients
Coating Systems & Additives
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Levulan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levulan, including repackagers and relabelers. The FDA regulates Levulan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levulan 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 Levulan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levulan supplier is an individual or a company that provides Levulan active pharmaceutical ingredient (API) or Levulan finished formulations upon request. The Levulan suppliers may include Levulan API manufacturers, exporters, distributors and traders.
click here to find a list of Levulan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levulan DMF (Drug Master File) is a document detailing the whole manufacturing process of Levulan active pharmaceutical ingredient (API) in detail. Different forms of Levulan DMFs exist exist since differing nations have different regulations, such as Levulan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levulan DMF submitted to regulatory agencies in the US is known as a USDMF. Levulan USDMF includes data on Levulan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levulan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levulan 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 Levulan Drug Master File in Japan (Levulan JDMF) empowers Levulan 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 Levulan JDMF during the approval evaluation for pharmaceutical products. At the time of Levulan 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 Levulan 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 Levulan Drug Master File in Korea (Levulan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levulan. The MFDS reviews the Levulan KDMF as part of the drug registration process and uses the information provided in the Levulan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levulan 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 Levulan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levulan suppliers with KDMF 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 Levulan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levulan 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 Levulan 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 Levulan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levulan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levulan suppliers with NDC on PharmaCompass.
Levulan 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 Levulan 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 Levulan GMP manufacturer or Levulan GMP API supplier for your needs.
A Levulan CoA (Certificate of Analysis) is a formal document that attests to Levulan's compliance with Levulan specifications and serves as a tool for batch-level quality control.
Levulan CoA mostly includes findings from lab analyses of a specific batch. For each Levulan 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.
Levulan may be tested according to a variety of international standards, such as European Pharmacopoeia (Levulan EP), Levulan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levulan USP).
LOOKING FOR A SUPPLIER?
