This Request Page has been designed in an interactive format that will prompt you to provide us with the specific information we need in order to process your request. Please fill in all required fields.
Select Checkbox to Include
MSDS
Material Safety Datasheet
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Product Regulatory Datasheet (PRD)
Product specific document that contains information on ingredient source, BSE/TSE, allergens,gluten, GMO's, resdiual solvent,aflatoxin, Prop 65 and other product specific information.
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Product Specification
Includes Qualitative Disclosure
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Test Method
Colorcon method of analysis for a specified attribute
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Certificate of Analysis
Typical/Example (not batch specific)
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Kosher Certificate
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Nutritional Statement
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Drug Master File (DMF Reference)
Letter of Reference allowing FDA or Health Canada to access Colorcon's Drug Master File on behalf of an applicant.
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
ARTG Number (AU)
Australian Register of Therapeutic Goods (ARTG) Number for Colorcon Formulated Products
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Quantitative Disclosure
Contains Quantitative details for specific formulated Colorcon Product. An applicable Confidentialtiy Agreement is required.
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Regulatory Assessment
Customized, product specific regulatory assessment based on your individual needs.
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Please select the countries/regions in your target market. To select multiple values, press the ctrl key while clicking on the desired values.
If the country of interest is not listed, please submit the request using General Question (Regulatory).
Each product assessment is individually prepared. Requests that require evaluation of use in many countries may extend the time needed to prepare the assessment.
Compliance Statement for EU Purity Criteria for Colours
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Color Regulation Information
Report from Colorcon's extensive color regulations database for colorants available in Colorcon formulated products. Customized reports provide a list of the colors selected that are permitted in all of the countries selected.
Country
Colorant
Site Quality Overview
Site and Supply Chain Security Overview
Lake Certification
Lot Number(s)
Please provide sublot(s) for Lake products.
Pure Dye Content
Approximate pure dye content for a specific formulated Colorcon Product
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
IR Scan
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
UV Reference Scan
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
Example Label
Colorcon Product Line
Stability Summary
Colorcon internal report providing justification for a product re-evaluation date
Enter the Colorcon Product Code only. Do not include product name or color. Separate multiple codes with a comma.
