Japan · APIs · 原薬等登録原簿 (MF)

Japan Drug Master File (MF/DMF) Tracker

Name: Japan Drug Master File (MF) registrations: monthly counts by registrant country
Creator: Japan Pharma Regulatory Brief

New Japan DMF registrations from PMDA's Master File list, in English: how many per month and from which countries, which molecules, and where they meet Japan's drug shortages. How the MF system, in-country caretakers and accreditation work ↓

Last updated: 2026-09-27 · PMDA MF list as of 2026-08-15 · foreign manufacturer list as of 2026-09-16 · source: PMDA (PDL1.0), edited and translated

New Japan DMFs per month, by registrant country

New MF registrations by month of first registration, last 24 months. Choose APIs & intermediates for drug-substance filings; All MF types adds culture media, excipients and other materials — most new US and UK filings are culture media (54 US/UK MFs of all types in the last 12 months, 1 of them APIs). Hover a month for the numbers. Download: monthly counts by country (CSV, aggregated).

APIs & intermediatesAll MF types (incl. culture media, excipients)

China
India
Japan
South Korea
Europe (incl. UK & Switzerland)
United States
Other / unknown

Show as a table

Month	China	India	Japan	South Korea	Europe (incl. UK & Switzerland)	United States	Other / unknown	Total
Aug 26*	1	1	3	0	0	0	0	5
Jul 26	6	3	0	1	4	0	0	14
Jun 26	5	4	1	0	2	0	0	12
May 26	3	3	0	1	0	0	0	7
Apr 26	6	6	4	0	2	0	0	18
Mar 26	6	1	2	0	1	0	0	10
Feb 26	12	4	4	0	2	0	0	22
Jan 26	9	4	3	4	2	0	1	23
Dec 25	4	4	1	0	2	0	0	11
Nov 25	4	3	2	0	2	0	0	11
Oct 25	7	4	1	0	2	0	0	14
Sep 25	3	2	1	1	1	0	0	8
Aug 25	8	3	2	0	2	0	0	15
Jul 25	7	7	3	2	2	0	0	21
Jun 25	1	2	2	0	3	1	1	10
May 25	2	0	0	1	0	0	0	3
Apr 25	5	3	1	1	1	0	1	12
Mar 25	2	0	1	0	1	0	1	5
Feb 25	5	7	3	0	3	0	0	18
Jan 25	5	5	3	1	8	0	0	22
Dec 24	3	2	4	2	12	0	0	23
Nov 24	4	3	1	1	5	0	0	14
Oct 24	0	6	0	1	2	0	0	9
Sep 24	3	4	2	2	1	0	0	12

Show as a table

Month	China	India	Japan	South Korea	Europe (incl. UK & Switzerland)	United States	Other / unknown	Total
Aug 26*	1	1	3	0	0	0	0	5
Jul 26	6	3	0	2	5	4	0	20
Jun 26	5	4	1	0	5	4	1	20
May 26	3	3	0	1	0	3	0	10
Apr 26	6	6	4	0	2	1	0	19
Mar 26	6	1	2	0	4	0	0	13
Feb 26	13	4	5	0	2	0	0	24
Jan 26	9	4	3	6	5	5	1	33
Dec 25	4	4	1	0	8	2	0	19
Nov 25	4	3	2	0	7	6	0	22
Oct 25	7	4	4	0	12	7	0	34
Sep 25	3	2	1	1	2	1	0	10
Aug 25	8	3	3	0	2	1	0	17
Jul 25	7	7	3	2	5	4	0	28
Jun 25	1	2	2	0	3	2	1	11
May 25	2	0	2	1	3	3	0	11
Apr 25	5	3	1	1	7	5	1	23
Mar 25	2	0	3	0	2	2	1	10
Feb 25	5	7	3	1	3	2	0	21
Jan 25	5	5	4	1	11	8	1	35
Dec 24	3	2	4	2	16	0	0	27
Nov 24	4	3	2	1	5	0	0	15
Oct 24	0	6	3	1	4	12	1	27
Sep 24	3	4	2	2	1	1	0	13

Country = country in the registrant's address (a foreign registrant's MF is filed through its Japanese in-country caretaker, but the registrant is the foreign company). * August 2026 is partial: the PMDA list is dated 2026-08-15, and registrations from later in the month appear in the next notice.

Top 15 ingredients with new MFs (September 2025–August 2026)

APIs and intermediates. Several registrants filing for the same molecule in a year usually means Japanese generic makers are sourcing it (for example ahead of a patent expiry).

#	Ingredient (English / Japanese)	New MFs	Registrant countries (top 3)
1	Tofacitinib トファシチニブ	7	China 3, Japan 2, India 2
2	Macitentan マシテンタン	6	Japan 3, China 2, India 1
3	Venlafaxine ベンラファキシン	6	China 3, India 2, Japan 1
4	Apixaban アピキサバン	3	China 2, South Korea 1
5	Edoxaban エドキサバン	3	China 2, India 1
6	Indometacin インドメタシン	3	China 3
7	Rasagiline ラサギリン	3	Japan 1, South Korea 1, Malta 1
8	Riociguat リオシグアト	3	China 1, Japan 1, India 1
9	Acetaminophen アセトアミノフェン	2	China 2
10	Cefuroxime axetil セフロキシムアキセチル	2	China 2
11	Desloratadine デスロラタジン	2	India 2
12	Dienogest ジエノゲスト	2	Italy 2
13	Epinastine エピナスチン	2	South Korea 1, China 1
14	Iguratimod イグラチモド	2	China 2
15	Ketoconazole ケトコナゾール	2	China 2

Latest 20 API filings

The 20 most recent API/intermediate MFs on PMDA's list (as of 2026-08-15), by first registration date. The free list shows the date, ingredient and registrant country only.

Registered	Ingredient (English / Japanese)	Registrant country
2026-08-05	Rasagiline ラサギリン	Japan
2026-08-05	Tofacitinib トファシチニブ	Japan
2026-08-05	Riociguat リオシグアト	China
2026-08-05	Riociguat リオシグアト	Japan
2026-08-05	Bosutinib ボスチニブ	India
2026-07-29	Rasagiline ラサギリン	South Korea
2026-07-29	Tofacitinib トファシチニブ	China
2026-07-29	Iopamidol イオパミドール	China
2026-07-29	Granisetron グラニセトロン	China
2026-07-22	Nintedanib ニンテダニブ	India
2026-07-22	Clotiazepam クロチアゼパム	Italy
2026-07-15	Duloxetine デュロキセチン	India
2026-07-15	Estradiol valerate エストラジオール吉草酸エステル	Netherlands
2026-07-15	Rasagiline ラサギリン	Malta
2026-07-15	Tofacitinib トファシチニブ	China
2026-07-08	Amlodipine アムロジピン	India
2026-07-08	Nintedanib ニンテダニブ	China
2026-07-08	Diflucortolone valerate ジフルコルトロン吉草酸エステル	Italy
2026-07-01	Testosterone enanthate テストステロンエナント酸エステル	China
2026-06-25	Riociguat リオシグアト	India

Japan drug shortages × MF registrants: top 10

Ingredients with products on limited shipment or suspended in Japan (MHLW file of 2026-09-25, excluding NHI delisting), ranked by shortage severity relative to the number of distinct MF registrants for the drug substance. See the Japan drug shortage tracker for the shortage side.

#	Ingredient	Products limited + suspended limited / suspended	MF registrants	Foreign registrant countries (top)
1	Cefaclor セファクロル	10 2 / 8	2	China 1, Italy 1
2	Iomeprol イオメプロール	5 0 / 5	0 †	—
3	Lidocaine hydrochloride リドカイン塩酸塩	11 5 / 6	2	Sweden 1
4	Pyridoxal phosphate hydrate ピリドキサールリン酸エステル水和物	7 5 / 2	1	none (Japan only)
7	Glycyrrhizin / glycine / cysteine combination グリチルリチン・グリシン・システイン配合剤	5 3 / 2	0 †	—
8	Theophylline テオフィリン	14 9 / 5	3	China 2
9	Isosorbide dinitrate 硝酸イソソルビド	10 6 / 4	2	none (Japan only)
10	Iohexol イオヘキソール	9 0 / 9	3	China 3
11	Dexamethasone sodium phosphate デキサメタゾンリン酸エステルナトリウム	9 9 / 0	1	France 1
12	Flecainide acetate フレカイニド酢酸塩	8 8 / 0	1	Italy 1

Read with care: MF registration is not mandatory in Japan — an API source can be written directly into the drug maker's application — so “few MF registrants” is not “few suppliers”. Many shortages are caused on the formulation side (manufacturing, quality, demand surges), which more API sources would not fix. † = no MF found under this name (could be a naming difference, or the API is supplied through the maker's application). Blood products, infusions, kampo and other non-chemical products are left out. # = rank in the full table. Check the sources before acting.

Accredited foreign drug manufacturers by country

Active accreditations of foreign manufacturers of drugs (医薬品外国製造業者) on the list PMDA publishes for MHLW, as of 2026-09-16 — one per manufacturing site and category, excluding abolished and expired ones. Accreditation is required before a foreign site can supply a drug or API to Japan, and before an MF can be filed.

Country / territory	Accreditations	Share
China	538	21.3%
United States	350	13.9%
India	321	12.7%
Germany	185	7.3%
Italy	127	5.0%
France	123	4.9%
South Korea	108	4.3%
Switzerland	82	3.3%
Spain	82	3.3%
United Kingdom	70	2.8%
Taiwan	60	2.4%
Ireland	56	2.2%
Netherlands	50	2.0%
Belgium	46	1.8%
Denmark	33	1.3%
Canada	33	1.3%
Sweden	26	1.0%
Singapore	22	0.9%
Austria	20	0.8%
Puerto Rico (US)	18	0.7%
Other (34 countries / territories)	172	6.8%
Total	2,522	100%

What the full MF table adds (subscribers)

This page is the free summary. The planned subscriber edition adds:

Every new MF, every two weeks — the full table for each PMDA notice: MF number, type, item name (Japanese + English), registration dates.
Registrant details — registrant name and address, all their MFs, and foreign-manufacturer accreditation status.
The full shortage × MF table — all 506 ingredients, with shortage status, reason split, share of products affected, MF holders by country and first-seen dates.
CSV of every table, and ingredient alerts: an email when a molecule you choose gets a new MF or a new shortage.

Join the free weekly email to get the Japan MF headline now and the launch note for the full table. Sign up free ↓

What is a Japan Drug Master File (MF / “Japan DMF”)?

Japan's Master File (MF) system (原薬等登録原簿) lets Japanese or foreign manufacturers of drug substances voluntarily register quality and manufacturing data with the Pharmaceuticals and Medical Devices Agency (PMDA). A drug maker's marketing application quotes the MF number, and the registered data are reviewed as part of that product's approval review. There is no fee for MF registration. The point is the same as a US DMF: the API maker's know-how stays confidential from its customer.
What can be registered: drug substances (APIs), intermediates and pharmaceutical product materials, new excipients, and container/packaging materials, among others. The application form must be written in Japanese (Article 283 of the Enforcement Regulation); Module 3 data may be attached in English or Japanese.
In-Country Caretaker (ICC). A foreign manufacturer applying for MF registration must appoint a person with an address in Japan to handle the registration (the in-country caretaker of drug substances, Article 280-3 of the Enforcement Regulation). Foreign holders cannot file with PMDA directly; the ICC submits the forms and relays PMDA's queries.
Foreign manufacturer accreditation (AFM). A manufacturer outside Japan that makes drugs for export to Japan — including one that makes only the drug substance — must be accredited by the Minister of Health, Labour and Welfare (Article 13-3 of the PMD Act). PMDA examines the site's buildings and facilities; accreditation is per site and category and must be renewed every 5 years. The MF form asks for the accreditation category, number and date, so accreditation comes first.
MF registration is not mandatory. API information can instead be written directly into the drug maker's application, so a low MF count does not prove a low number of suppliers.

Checked against PMDA's English pages on 2026-09-27: Master File System, Master File System for Drug Substances, etc. (PDF), Accreditation of Foreign Manufacturers and Application for Accreditation of Foreign Manufacturers (PDF). This is a summary, not regulatory advice; the Japanese originals prevail.

Methodology

PMDA publishes a cumulative Excel list of all current MFs with each notice. We keep the latest copy and count MFs by first registration date (初回登録年月日). MFs later withdrawn drop off PMDA's list, so older months can shrink slightly.
Type (API, intermediate, excipient, container, other) is from the registration category and item name; “other” is mostly culture media and cell-culture materials.
Country is read from the registrant's address; where the address is unclear the foreign-manufacturer list is used. The registrant's country can differ from the actual manufacturing site.
English ingredient names come from our dictionary (salts and hydrates folded into the base molecule): 140 of 155 API/intermediate MFs in the last 12 months have one; the rest keep the Japanese name (JP).
The CSV has monthly counts by country and type group for the 24 months shown — no MF-level data.

Sources & attribution

Source: Pharmaceuticals and Medical Devices Agency (PMDA) website (https://www.pmda.go.jp/), PDL1.0: “原薬等登録原簿（MF）の公示” (public notice of Master File registrations, https://www.pmda.go.jp/review-services/drug-reviews/master-files/0008.html, list as of 2026-08-15) and “外国製造業者認定・登録番号の公表” (accredited foreign manufacturers, https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html, as of 2026-09-16). Shortage counts: Ministry of Health, Labour and Welfare (MHLW), “医療用医薬品供給状況” (https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/kouhatu-iyaku/04_00003.html, file of 2026-09-25), PDL1.0. Created by editing, translating and aggregating these materials (English ingredient names, country assignment, monthly counts, the shortage join and charts are ours). Not an official PMDA or MHLW list.

出典：独立行政法人医薬品医療機器総合機構（PMDA）ウェブサイト「原薬等登録原簿（MF）の公示」（https://www.pmda.go.jp/review-services/drug-reviews/master-files/0008.html）、「外国製造業者認定・登録番号の公表」（https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html）及び厚生労働省ホームページ「医療用医薬品供給状況」（https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/kouhatu-iyaku/04_00003.html）を加工して Japan Pharma Regulatory Brief が作成

Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0); see PMDA's site policy. This page is not made by, affiliated with or endorsed by PMDA or MHLW. The English text is an unofficial translation; the Japanese originals prevail.

Last built: 2026-09-27.