FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

At a Glance

• The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, Raptim Research Pvt. Ltd.
• This finding has different ramifications for sponsors of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) depending on whether the data was generated during an in vitro or an in vivo study.
• FDA is requiring any sponsor that relies on Raptim Research’s in vitro study data as an essential part of an approved or pending NDA or ANDA to repeat the study at a different site; the agency will consider reliance on Raptim Research’s in vivo studies on a case-by-case basis.

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization (CRO), Raptim Research Pvt. Ltd.¹ This finding followed an inspection conducted by the FDA’s Bioresearch Monitoring Program (BIMO) in April 2023 and post-inspection data analysis.² Sixteen months later, in August 2024, FDA wrote to Raptim Research to address issues concerning studies conducted at its Mumbai facility between 2019 and 2023, including concerns with data integrity and potential data falsification. Additional correspondence was exchanged, including FDA’s rejection of proposed corrective and preventive actions (CAPA), and FDA held a regulatory meeting with Raptim Research in February 2025.

In an untitled letter dated March 27, 2025, FDA addressed significant issues with both in vitro and in vivo studies that were conducted by Raptim Research from 2019 to 2023.

In Vitro Study Conduct

According to FDA, Raptim Research’s in vitro study conduct “resulted in the submission of false information” concerning the bioavailability of certain drug products.³ Specifically, FDA’s review of four studies in support of certain ANDAs revealed that Raptim Research “reanalyzed or reused skin donor replicates from one donor whose results [Raptim Research] knew and recorded them as different skin donor replicates from a different donor in a different study.”⁴ As a result, FDA determined that any study data from an in vitro study conducted by Raptim Research must be rejected. Any sponsor that relies on such data as an essential part of its NDA or ANDA, whether approved or still under FDA review, must repeat the study at a different site.

In Vivo Study Conduct

Further, FDA identified significant issues with Raptim Research’s conduct of various in vivo studies. Although there is no allegation that Raptim Research falsified data in its in vivo studies, FDA called into question the “reliability of [Raptim Research’s] methods and the study results generated using those methods.”⁵ These concerns stem from processes and procedures that result in “inconsistent study practice,” including frequent repeat analysis of valid sample results and failure to perform repeat analysis on invalid sample results.”⁶

Conclusion

For those companies that have relied on Raptim Research’s data in support of an NDA or ANDA, the upshot depends on whether the data was generated during an in vitro or in vivo study. Any data that was generated during the former is “not acceptable” and will be rejected. However, FDA offers more flexibility concerning data that was generated during an in vivo study. Indeed, FDA will review such data on a “case-by case basis” during the evaluation of the sponsor’s NDA or ANDA.⁷ During this time, sponsors can address the concerns associated with in vivo studies by “re-analyzing the study samples and re-conducting statistical analysis to demonstrate bioequivalence, or conducting a new study.”

FDA has not made public the exact number of drugs affected, but we know there are a significant number of applications that relied on bioequivalence and bioavailability studies conducted by Raptim Research. FDA wrote a letter to each of the implicated sponsors, informing them of the potential need to redo studies and to submit new data to support maintenance of their marketing applications. FDA also changed the therapeutic equivalence (TE) rating in the Orange Book for any approved ANDA that relied on bioequivalence data from Raptim Research to BX, making the generic no longer automatically substitutable for branded drugs at pharmacies.

This announcement demonstrates FDA’s continued willingness to scrutinize regulatory submissions and its ability to pay close attention to the quality of study data. For sponsors of clinical trials, it serves as a reminder of the importance of adequately vetting CROs before you engage them and conducting due diligence throughout the relationship.