Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Panexcell Clinical Lab or Synchron Research Services Are Unacceptable
[09/16/2021] FDA is notifying sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that clinical and bioanalytical studies conducted by Synchron Research Services or Panexcell Clinical Lab are not acceptable because of data integrity concerns, and the studies must be repeated.
FDA is taking this action as a result of inspections at Synchron’s and Panexcell’s facilities, as well as FDA analyses of study data generated at these companies and submitted in several applications, that found significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA. The agency issued “untitled letters” to Synchron and Panexcell detailing our findings related to each facility. A copy of the letters and other information on the respective facilities is available below.
FDA is requiring sponsors of approved, tentatively approved, or currently under review applications, to repeat the bioequivalence/bioavailability studies, when those studies are essential for approval, using an entity other than Synchron, Panexcell, or any other contract research organizations with known unresolved data integrity concerns. FDA encourages affected sponsors to contact the relevant FDA review division in the Office of Generic Drugs or the Office of New Drugs for further information.
The agency is conducting a review of currently approved products to ensure this data integrity issue will not affect public health.
FDA has determined that data from Synchron or Panexcell are not acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic products are bioequivalent to brand name products. FDA is changing the therapeutic equivalence rating to “BX” for any approved ANDA that relied on data from Synchron or Panexcell. A “BX” rating indicates data reviewed by the agency are insufficient to determine therapeutic equivalence (substitutability) of the generic product to its brand name product. A drug with a “BX” rating is still approved and can be prescribed but is not recommended as automatically substitutable at the pharmacy (or by a pharmacist) for the brand-name drug.
FDA has been conducting an investigation of postmarket safety reports for marketing applications that relied on bioequivalence studies conducted by Synchron or Panexcell for approval. To date, the agency has not identified signals related to problems with the safety or quality of the approved drugs. FDA remains vigilant and if the agency finds safety issues, we will take action and provide the latest information as appropriate. Patients should not make changes to their treatment except in consultation with their health care professional.
FDA is committed to protecting the health of the American public by holding approved products to high standards of quality, safety, and efficacy. Additional information is available on the Questions and Answers Regarding Data Integrity Violations at Panexcell Clinical Lab and Synchron Research Services webpage.
Panexcell Clinical Lab
Panexcell is a contract research organization located in Navi Mumbai, India, that conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies. During an inspection conducted between November 18 and 22, 2019, FDA found significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA. On September 15, 2021, FDA issued an “untitled letter” to Panexcell detailing its findings related to their facility and concerns identified in FDA review of data originating at Panexcell.
Additional Information
Synchron Research Services
Synchron is a contract research organization located in Ahmedabad Gujarat, India, that conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies. During an inspection conducted between November 18 and 22, 2019, FDA found significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA. On September 15, 2021, FDA issued an “untitled letter” to Synchron detailing its findings related to their facility and concerns identified in FDA review of data originating at Synchron.
Additional Information