The cost and time spent on filing an ANDA with FDA are demanding. Once all aspects of the file are ready for submission, it would be assuring to know that you’ve done all you can to be granted approval. There are four major areas that FDA cites in Good ANDA Submission Practices-Guidance for Industry which applicants should pay special attention to:
- Product quality
- Patent and exclusivity
Experts exist to review and guide generic pharmaceutical companies through each of these areas to avoid the delays and costs associated with not providing full information to FDA with their ANDA submission. Avomeen serves a multitude of biopharmaceutical clients to address the deficiencies found in the product quality section of the ANDA. Within this section of the guidance, there are some common themes from applicants that lead for deficiencies rather than approval.
Impurity Control is Essential to a Successful ANDA Submission
Impurity control is an area that tends to be missed in ANDAs, or at least not fully supported. From characterization of the drug product through full evaluation of the manufacturing train in terms of chemical contaminants, Avomeen has the knowledge and instrumentation to identify impurities and recommend a path forward that stand up to regulatory scrutiny, whether method development and validation are required, or simple assays are needed. We’ve developed enough analytical methods over the years in our cGMP-compliant facilities to know if a method is suitable to back up the intended use in controlling product quality.
More common types of impurities that we deal with are residual solvents and elemental impurities. As test-to-RLD comparisons become more intensive, utilizing appropriate dissolution methodology has also been identified by the FDA as a common deficiency occurring in ANDA applications. Avomeen follows recommendations in USP <1092> for development and validation of these tests.
The Right Analytical Partner to Support your ANDA
We also handle more complex analytical projects such as grade identification of excipients in order to make Q1/Q2 comparisons to the reference listed drug (RLD). Impurity profiles are also important to understand when comparing the test product to the RLD, and Avomeen is able to provide full characterization as needed for verifying impurities in-line with regulatory expectations.
In a more general sense, FDA has also refused to approve ANDAs where analytical methods have not been validated appropriately. FDA recommends labs follow ICH Q2 (R1) procedures. Avomeen is deeply familiar with designing and conducting appropriate validations to ensure that both the results and inference made from analytical data are scientifically sound.
Plan to succeed in obtaining approval for your ANDA by consulting with Avomeen experts on any of these issues, and more.
Our featured blogger is Mike Lindenmuth, Avomeen’s Director of Business Development for the Mid-Atlantic and Southeast regions. Mike has been involved in the pharmaceutical industry for nearly 20 years, from working in drug discovery to serving in technical sales and business development roles for organizations supporting pharmaceutical research and development.