In case you thought Covid-19 had slowed down the speed at
which generic active
pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the
US Food and Drug Administration (FDA), you are in for a pleasant surprise.
During the first half of this year, the industry maintained its momentum of
filing DMFs with the FDA.
In the
first six months of this year, FDA received 283 DMF submissions (against 616
for the full year of 2019). Expectedly, India continued to lead with 155 DMF
filings. Submissions from India were more than double the amount of those made
by Chinese (45) and American firms (30) combined.
This
trend has been witnessed for some time now. In 2019, out of the 616 active DMF submissions to the FDA, Indian
companies had submitted more than half (331), though the submissions from India
were a little less than double of those made by Chinese and American firms.
Drug
master files (DMFs) are submissions made to the FDA by manufacturers who
provide the agency with confidential, detailed information about facilities, processes,
or articles used in manufacturing, processing, packaging, and storing of
human drug products.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)
India’s MSN Labs leads total count of DMF filings
As in the past, India’s MSN Laboratories continued to
lead the DMF filings by a single company with 40 submissions, followed by Dr Reddy’s (8) and Metrochem API (7).
MSN has always been a pioneer in being the first to file a DMF for new products. This year was no different. The firm submitted the first DMF for 11 products — Abaloparatide, Abemaciclib, Amifampridine Phosphate, Betrixaban Maleate, Fenfluramine Hydrochloride, Lofexidine Hydrochloride, Neratinib Maleate, Ozenoxacin, Rolapitant Hydrochloride, Tafamidis, Valbenazine Tosylate.
There
were also first DMF filings by AMRI (Brexanolone), Formosa Laboratories (Elagolix Sodium), Glenmark Life Sciences (Solriamfetol Hydrochloride) and Hikal (Ertugliflozin L-Pyroglutamic Acid).
The API
DMF is part of the final generic drug product submission to the FDA. Therefore,
the owner of a DMF incurs a one-time fee, the first time the generic drug
submission references that DMF. DMF holders may also pay the fee in advance in
order to have their DMF subjected to an initial completeness assessment by the
FDA. This would allow their DMF to be included on a publicly available list of
DMFs that have paid their fee and have not failed the initial completeness
assessment.
View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)
Assessment
review of only 62 DMFs completed by the FDA
While 283 DMFs were submitted to the FDA, only 22 percent of them — or 62 DMFs — have had their assessment review completed by the FDA so far. The GDUFA fee associated with a DMF assessment review for the current fiscal year is US$ 57,795. It has been revised upward
to US$ 69,921 (an increase of US$ 12,126) for the upcoming fiscal year, which
starts in October.
Although
MSN led in the number of DMF filings, it had no assessments completed for its
DMF submissions in the first half of the year. Three Indian companies, Aurobindo, Honour Lab and Intas, and one Chinese company, Jiangsu Hengrui, led in the maximum (three
each) number of assessments completed by the FDA.
The
products with the most commonly filed DMFs were Brivaracetam, Cetrorelix, Edaravone and Lifitegrast, with four
submissions each.
DMF filings also help provide insights into some of the new
drug approvals that can be expected in the future. In the first half of the
year, we witnessed submissions for Dapoxetine Hydrochloride (MSN), Fasoracetam (MSN), Indoximod (MSN), Resiniferatoxin (Indena), Omidenepag Isopropyl (UBE Industries), Treosulphan (Fermion), Roxadustat (Dr Reddy’s), Bexagliflozin (Piramal), Antazoline Phosphate (Metrochem)
and Dyphylline (Shanghai Wonder) which are all products that
have currently not been approved by the FDA and could potentially be approved
in the future.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)
Our view
The Covid
crisis and the surging demand for APIs like hydroxychloroquine, favipiravir and dexamethasone has revealed the global
dependence on India and China for APIs.
India, a
prominent API manufacturer, admitted to its extreme dependence on China
for APIs and intermediates when it shared a list of products which
included antibiotics, vitamins, hormones and even commonly used medicines
like aspirin and paracetamol.
In July this year, India announced the guidelines for its schemes for the development of bulk drugs and medical device parks across the country. These schemes are part of India’s self-reliance campaign. Similar reshoring initiatives have been announced by the United States, France
and Japan, and many other countries
also want to reduce their reliance on China.
While shifting supply chains is certainly a long drawn out process, the wheels have definitely started to turn. It remains to be seen what impact these initiatives will have on the DMF filings with the FDA in the next few quarters.
View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)
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