Indian firm, 26 others cited for failing to pay GDUFA fees

By Zachary Brennan contact

- Last updated on GMT

Related tags: Food and drug administration

Indian firm, 26 others cited for failing to pay GDUFA fees
Indian generic manufacturer Marck Biosciences has received a warning letter from the US FDA for failing to pay its annual facility fees for the past two years, which for foreign fixed-dose formulation facilities in 2014 was $235,152.

The warning letter​ noted that the facility was identified in a pending and/or approved ANDA (Abbreviated New Drug Application) on the dates for self-identification for FY 2013 and 2014.

The facility has self-identified for 2013 and 2014 but, has not paid the 2013 or 2014 facility fees as required by GDUFA [Generic Drug User Fee Amendment]. Therefore, all finished dosage forms of drugs or APIs, as well as drug containing an API, manufactured at the facility are misbranded​,” the FDA warned.

But the problems for Marck Biosciences extend beyond their failure to pay the facility fees. The firm was cited in a warning letter in August for data falsification and unsanitary conditions​.

Marck did not respond to a request for comment.

Other Firms

Germany-based CMO CPM Contract Pharma in 2013 became the first firm to receive a warning letter​ for failing to pay a facility fee.

Twenty-seven firms are included on this year’s arrears list​ for GDUFA facilities. Meanwhile, 20 other firms, including Pfizer, Bristol-Myers Squibb and AstraZeneca are included in a list of companies with outstanding facility fees​.

Only facilities that manufacture positron emission tomography drugs are exempted from the facility fee and other GDUFA fee requirements.

Foreign generic firms saw a more than $40,000 increase in facility fees in 2014 when compared with the fees for 2013.

Related topics: Markets & Regulations, QA/QC, Regulations

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