American drug regulator US FDA has listed facilities of Indian companies, including those of stock-exchange listed Biocon and Sharon Bio-Medicine, among the ones who have not paid the annual facility fee.
This means no new generic drug submission linked to the facility will be received until the fees are paid.
As fees for the current financial year, each foreign API (active pharmaceutical ingredients) facility was directed to pay $60,367 and every foreign FDF (finished dosage form) unit required to shell out $226,087.
For this fiscal, the facility fee was due on October 2. The facility is placed on a publicly available arrears list if the fee is not fully paid within 20 days of the due date.
“The following facilities have not satisfied one or more annual facility fee(s) as required under the Generic Drug User Fee Amendments (GDUFA). Failure to timely submit the annual facility payment means that the Food and Drug Administration (FDA) will not be able to receive new ANDAs (abbreviated new drug applications) or PASs (prior approval supplements) referencing these facilities... The FDA will also not be able to receive applications submitted by the owners, or affiliates of the owners, of these facilities,” said a US FDA list dated December 8, 2017.
A total of 33 foreign facilities are mentioned in the GDUFA facility arrears list. The list includes Biocon Ltd (FEI Number 3003981475), Deccan Nutraceuticals Private Ltd (FEI Number 3007607026), Sidmak Laboratories India Private (FEI number 3008127341) and Flamingo Pharmaceuticals Ltd (FEI number 3005636769). Besides, there is mention of two facilities belonging to Sharon Bio-Medicine Ltd (FEI numbers 3005925733 and 3004455093) marked with an “N/A” status for FY2018.
The FEI (FDA Establishment Identifier) number is assigned by the US FDA for tracking inspections.
The US FDA notifies the ANDA applicant of the facility’s failure to satisfy its user fee obligations. Furthermore, all FDFs or APIs manufactured in a non-paying facility and all FDFs containing APIs manufactured in such a facility will be deemed misbranded. This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States.
Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products misbranded because of failure to pay facility fees are subject to being denied entry into the United States, as per US FDA.
If a company believes that its appearance on the arrears list is an error, it is required to contact the Generic Drug User Fee staff at US FDA for correction.
MISSED DOSE
- For this fiscal, the facility fee was due on October 2
- Products misbranded because of failure to pay facility fees are subject to being denied entry into the US, as per US FDA
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
 "Pharma sector")
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}