FDA DMF filings 2020

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.


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.

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. Access full pharmacompass article here

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