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By PharmaCompass
2020-09-03
Impressions: 60336
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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Image Credit : FDA DMF Filings 2020 by PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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