Market Place
The deadline to pay the Generic Drug User Fee Amendments (GDUFA) dues to the US Food and Drug Administration (FDA) for financial year 2016 expired last week. The GDUFA law was introduced in 2012 to speed up access to safe and effective generic drugs. The law mandated the industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
The fee, unlike in some other countries, is not insignificant (see the table below). However, 1,578 facilities, that manufacture or intend to produce active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for the US market, ‘self-identified’ with the FDA.
|
GDUFA fee for FY 2016 |
||
|
Facility |
Domestic API |
US $ 40,867 |
|
Foreign API |
US $ 55,867 |
|
|
Domestic FDF |
US $ 243,905 |
|
|
Foreign FDF |
US $ 258,905 |
|
Our analysis this week attempts to provide an insight into
companies that have ambitious business plans for the US market, while also
looking at others that have decided to withdraw due to either compliance
concerns or unviability of their American business.
India and China lead the charge of new listings
Unlike the past few years when many new facilities got listed, this year our analysis shows less than 50 new API and FDF facilities getting registered with the FDA. However, unsurprisingly, almost 60 percent of these new listings were for manufacturing facilities located in India and China.
Most of the nine new Indian facilities that paid the fees, belong to established generic manufacturers such as Amneal, Biocon, Dr. Reddy’s, Intas and Lupin.
Aurobindo Pharma’s foray into one of the most complicated areas of organic chemistry – peptide chemistry – has been announced through the registration of its facility, Auro Peptides.
On the other hand, China – with 20 new facility registrations – has less-established companies with strong compliance records. Companies like Nantong Chanyoo and Sichuan Xieli, which demonstrated strong compliance records with European regulators, appear to be setting their sights on the US markets.
Established producer Zhejiang Kangle has two new facilities that paid the fees this year and this includes a paracetamol manufacturing division – Lianyungang Kangle Pharmaceutical Co. – which has recently undergone a series of successful foreign inspections.
And then there are others like Hubei Xunda, a leading ketoprofen manufacturer. Years after having filed its Drug Master File in the United States, the company is showing a renewed vigor to capture the American market.
While news reports have been doing the rounds of Chinese companies poaching Indian scientists to develop the finished formulation business for regulated markets, four new FDF facilities in China self-identified this year. Most of these facilities belong to the larger pharmaceutical operations in China like Zhejiang Hisoar’s subsidiary Jiangsu Hansoh and Yabao Pharmaceuticals.
Despite compliance issues, some companies paid up
Zhejiang Hisun Pharmaceuticals, recently subjected to an FDA import ban, “self-identified” its API operations in Nantong. Despite the FDA import alert, Hisun paid its dues for the facility which ran afoul with FDA regulators, indicating an expectation to get its compliance back online.
Hisun isn’t alone. Most companies across the world that had problems with international regulatory inspections recently, have chosen to pay the fees. Whether its Mylan’s operations in India or Ipca Laboratories, Emcure Pharmaceuticals, VUAB Pharma from the Czech Republic, Hikma Farmaceutica in Portugal, Minsheng Group Shaoxing Pharmaceutical Co or Jinan Jinda Pharmaceutical Chemistry of China, regardless of their regulatory challenges they have all paid the necessary amount to the FDA.
Over 100 facilities that didn’t pay the GDUFA fee
However, over 100 facilities with more than 20 facilities each in China, United States and India did not pay the 2016 fees. While some cases could be those of corporate oversight, there are others where compliance problems have been highlighted in the past.
IDT Biologika in Germany, Ben Venue Laboratories, Boehringer Ingelheim’s API facility in the United States, Sharon Bioscience, Parabolic Drugs, Cadila’s Zyfine facility in India and China’s Suzhou No. 4 Pharmaceutical Factory are examples of those that did not meet the October 1 deadline to pay the GDUFA fee.
Our view
The GDUFA fee is one of the many ways available to the pharmaceutical industry to assess the consistently evolving state of the pharmaceutical supply chain.
Forewarned is forearmed, and should our readers wish to receive our compilation of who is in and who is out, please email us at support@pharmacompass.com.
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Image Credit : Brisbane Lightening by Steve Arnold is licensed under CC BY 2.0
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