Data views / Active FDA Type II DMF holders

Active FDA Type II DMF holders

1,130 records Updated 9 July 2026

1130 suppliers in this directory hold at least one active US Type II drug master file. The list is ranked by active DMF count and shows each holder's latest FDA inspection outcome.

Top 100 of 1,130

SupplierActive US DMFsCEPsLatest FDA inspectionCountry
MSN Laboratories 517121NAI 2026India
Hetero 38067VAI 2025India
Apitoria Pharma 303173VAI 2025India
Dr Reddy's Laboratories 27990NAI 2025India
Alivus Life Sciences 27243NAI 2025India
Matrix Pharmacorp 223—VAI 2025India
Jubilant Biosys 182—VAI 2022India
Changzhou Pharmaceutical Factory 174—VAI 2024China
Olon 16780NAI 2025Italy
Cipla 161272VAI 2025India
Acs Dobfar 16018VAI 2023Italy
MSN Life Sciences 16048VAI 2024India
Biophore India Pharmaceuticals 152—NAI 2024India
Zydus Lifesciences 15052VAI 2025India
Neuland Laboratories 14831VAI 2025India
Alembic Pharmaceuticals 145124VAI 2025India
Wavelength Enterprises 136—NAI 2022Israel
Lupin 13537VAI 2025India
Macleods Pharmaceuticals 12952VAI 2024India
Laurus Labs 11828VAI 2025India
Curia 1168OAI 2026Spain
Cohance Lifesciences 10833NAI 2025India
Maithri Drugs 10624VAI 2025India
Natco Pharma 10212VAI 2025India
Granules India 9542VAI 2025India
Cambrex Profarmaco Milano 9418NAI 2022Italy
MSN Pharmachem 94—VAI 2023India
Siegfried 9440VAI 2025Germany
Solara Active Pharma Sciences 9132VAI 2026India
Chromo Laboratories India 88—VAI 2018India
Zhejiang Huahai Pharmaceutical 8668OAI 2025China
Honour Lab 799VAI 2019India
Gland Pharma 753VAI 2024India
Raks Pharma 72—NAI 2025India
ScinoPharm Taiwan 71—NAI 2022Taiwan
Apotex 699NAI 2025Canada
Biocon 6929VAI 2025India
Vasudha Pharma Chem 66—VAI 2025India
Dasami Lab 64—VAI 2025India
Mankind Pharma 6413VAI 2025India
Piramal Pharma 6229VAI 2025India
Symed Labs 6020VAI 2025India
Emnar Pharma 566VAI 2025India
Specgx 5616VAI 2025United States
Micro Labs 5584VAI 2025India
Alp Pharm Beijing 54——China
Lee Pharma 5416NAI 2025India
Optimus Drugs 53—VAI 2025India
Shilpa Pharma Lifesciences 5327NAI 2025India
Ipca Laboratories 52132VAI 2025India
Farmabios 51—VAI 2021Italy
Formosa Laboratories 518VAI 2024Taiwan
Valary Lab 50—VAI 2024India
Moehs 4934VAI 2023Spain
Symbiotec Pharmalab 49—VAI 2022India
Veranova Lp 49——United States
EUROAPI 4853VAI 2022France
Maithri Laboratories 467VAI 2025India
Amoli Organics 45—VAI 2024India
Orchid Pharma 4515VAI 2025India
F.I.S. Fabbrica Italiana Sintetici 43—VAI 2022Italy
HEC Pharm 434NAI 2024China
Shandong Xinhua Pharmaceutical 42——China
Aarti Pharmalabs 41—VAI 2026India
BrightGene Bio-Medical 413VAI 2024China
Quimica Sintetica 41—VAI 2023Spain
SMS Pharmaceuticals 4122OAI 2025India
Zaklady Farmaceutyczne Polpharma 41—VAI 2018Poland
Industriale Chimica 4031VAI 2022Italy
Sandoz 4020VAI 2024Switzerland
Supriya Lifescience 40—VAI 2026India
Synthimed Labs 4019NAI 2020India
Ami Lifesciences 3916VAI 2024India
Torrent Pharmaceuticals 399NAI 2026India
Aurisco Pharmaceutical Co.,Ltd 38——China
Alkem Laboratories 374VAI 2024India
Centaur Pharmaceuticals 3719VAI 2025India
Dipharma Francis 3616VAI 2022Italy
Apicore 351VAI 2025India
Aspen Oss 35——Netherlands
Aurore Life Sciences 3527VAI 2024India
Wisdom Pharmaceutical 35—NAI 2024China
Ajinomoto 3433VAI 2025Japan
COSMA 344VAI 2022Italy
Shandong New Time Pharmaceutical 348VAI 2024China
Unimark Remedies 34——India
PMC Isochem 33—VAI 2023France
Bachem 328VAI 2024Switzerland
Cadila Pharmaceuticals 3218NAI 2025India
Fermion 3223VAI 2023Finland
Fresenius Kabi 326NAI 2025Sweden
Hikal 3219OAI 2025India
MSN Organics 3211VAI 2023India
Shanghai Desano Chemical Pharmaceutical 3210VAI 2023China
Sterling Pharma Solutions 3223VAI 2025Malta
Arene Life Sciences 31—VAI 2024India
Divi's Laboratories 3126NAI 2025India
Harman Finochem 3129NAI 2025India
Morepen Laboratories 3114NAI 2023India
Navinta 311NAI 2024United States

Showing the top 100 of 1,130. Every row links to its full profile; the complete set is on the supplier index.

Where these figures come from

Every number on this page is counted from published registers — nothing is modelled or estimated. Records last refreshed 9 July 2026. How we count our figures.

Source
FDA, List of Drug Master Files
Source
FDA inspection classifications

Questions

What is an active Type II DMF?
A Type II drug master file is a confidential submission to the FDA describing how an active ingredient is manufactured. "Active" means the FDA lists it as current rather than withdrawn or inactive. A finished-dose maker references it when filing their own application.
How many suppliers hold an active US DMF?
1130 of the 3182 suppliers profiled here hold at least one active Type II DMF.
Does holding a DMF mean the supplier is FDA-approved?
No. A DMF is a filing, not an approval. It shows the supplier has documented its process with the FDA. Inspection outcomes are the separate signal, which is why they appear alongside the DMF count here.
How current is this list?
Compiled from the FDA drug master file list as published, with records last refreshed 2026-07-09.

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