What is PharmaExcel.com?
It is an open source platform developed by using and integrating publicly available databases of pharmaceutical drug products approved by Food and Drugs Administration (FDA) in United States. Public databases include but are not limited to Drugs@FDA, NDC directory, Orange Book, Drug Master Files, Inactive Ingredient Guidance, Dissolution Methods, Guidelines, etc. Our experts process these data based on their knowledge and understanding, and create links between datasets and transfer them into highly accessible and user-friendly interface.
The platform is primarily designed for students and professionals working closely with pharmaceutical market of United States. PharmaExcel is your companion for generic product identification in highly competitive market needs.
Who can use PharmaExcel?
- Business development professionals working to identify, screen and compare different pharmaceutical products.
- Formulation & analytical scientist working to develop pharmaceutical drug products can find useful information such as documents (reviews. labels, etc.), chemical properties (from PubChem), dissolution methods, patents (listed in orange book) and FDA product specific guidelines.
- Formulation scientist & regulatory specialist can predict the shelf life of drug product using Arrhenius equation.
- Analytical, regulatory or product development scientist can calculate reporting, identification and qualification threshold for impurity limits based on maximum daily dose.
- Scientist developing new pharmaceutical drug products can refer inactive ingredient guidelines (IIG) to confirm safe use of inactive ingredients.
- Regulatory Affairs members can see the approval history or documents of specific product or look up general guidelines available at FDA
- Marketing personnel from a generic development company can refer the pack style of reference listed drug product along with NDC code at their fingertips.
- Sourcing/purchasing group can check the list and status of DMFs along with completeness assessment status.
- Search for publicly available FDA guidelines.
- Intellectual property group members who want to refer orange book listed patents, PharmaExcel lists orange book listed patents with direct hyperlink to USPTO website and google patents.
- Any person seeking knowledge of pharmaceutical market or marketed product can refer this website for information only.
PharmaExcel integrates all the scattered information from different public domains to make it available as one stop platform to all its users. When all the information is scattered in different websites, it is challenging and cumbersome to visit all these different websites to find all available resources. We at PharmaExcel provide a comprehensive single platform with excellent user interface that makes it easier for our users to retrieve product information in organized manner. Some information is very difficult to retrieve from open source datasets, for example see below questions.
- Which reference listed drug products (RLD) in market have no potential generics?
- Which reference listed drug products (RLD) in market have 3 or less potential generics?
- Which RLD products have no unexpired patents or exclusivity?
- Which “Injectable” RLD products are approved in/after 2015 with no potential generics or unexpired patent/exclusivity?
- Find DMF (drug master file) holder along with status for particular API.
- Which RLD drug products are approved in/after 2013 and discontinued from market?
- Latest drug product label available at Drugs@FDA.
- All documents available at Drugs@FDA for particular product.
- Which RLD products’ patents and/or exclusivity are expiring in 2020?
- Which products are approved by FDA with patent number XXXXXXXX?
- What is the pack style for particular pharmaceutical product?
- What are dissolution method parameters for specific product?
- Find the latest label (PIL) of any particular FDA approved product.
- What is the limit of specific ingredient approved in any FDA approved product? (IIG limit)
- What are the other products approved by FDA for specific applicant?
- Does any particular API DMF passed completeness assessment and is available for reference by ANDA?