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List of Drug Master Files (DMF) for Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

USDMFs US Drug Master Files

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01 5Axplora

02 1ChemWerth Inc

03 12EUROAPI

04 2Minakem

05 3Minakem (formerly Delmar Chemicals)

06 107Sanofi

07 2Winthrop Pharmaceuticals

08 4Veranova

09 21Aspen API

10 3Bachem AG

11 6Evonik

12 7Fermion Oy

13 1PCAS

14 7Seqens

15 1Chemische Fabrik Berg

16 3Dr. Reddy's Laboratories

17 1Egis Pharmaceuticals PLC

18 3Fareva

19 1Malladi Drugs & Pharmaceuticals Limited

20 1Midas Pharma

21 5Moehs Iberica

22 4PMC Isochem

23 4Taro Pharmaceutical Industries

24 5Medichem S.A

25 1Noramco

26 12Pfizer CentreOne

27 2Pfanstiehl

28 1SCI Pharmtech

29 1Chunghwa Chemical Synthesis & Biotech

30 4Phytex Australia

31 193M Company

32 23M Drug Delivery Systems

33 4AAIPharma Services Corp.

34 1ABC Farmaceutici SpA

35 1ACE Japan Co Ltd

36 23ACIC Europe API & Pharmaceuticals

37 38ACS DOBFAR SPA

38 1AIR PRODUCTS FR 38070 Saint Quentin Fallavier

39 1ALMATICA PHARMA INC

40 1ALPS Pharmaceutical Ind. Co. Ltd.

41 1ALRA

42 4AMINO GmbH

43 1ANDRULIS PHARMACEUTICALS CORP

44 1ANI Pharmaceuticals Inc

45 1ARCH CHEMICALS INC

46 1ARCO Pharmaceuticals

47 1AXYNTIS Group

48 70Abbott Laboratories

49 3Abitec Corporation

50 3Actavis Inc

51 9Actylis

52 2Adare Pharma Solutions

53 1Aesica Pharmaceuticals Limited

54 1Ajay SQM Group

55 8Ajinomoto Company

56 7Ajinomoto OmniChem N.V.

57 3Akzo Nobel Polymer Chem LLC

58 2Albemarle Corporation

59 2Albert David

60 1Albion

61 5Alcon Inc

62 2Alfasigma

63 1Alkaloida Chemical Company Zrt

64 1Allied chemical Corp

65 3Alvogen

66 1Amcor

67 2American Chemical Products

68 2Amsa Spa

69 2Andenex-Chemie Engelhard + Partner GmbH

70 4Angelini Pharma

71 2Apotex Inc

72 2Applied Analytics™

73 1Applied Laboratories

74 1Archer Daniels Midland

75 6Archimica

76 2Arlin

77 2Asahi Kasei Finechem

78 2Asahi Vet Japan Co Ltd

79 2Ash Stevens, Inc.

80 4Ashland

81 4Assia Chemical Industries Ltd

82 6Astellas Pharma

83 15AstraZeneca

84 2Atabay

85 2Avanti Polar Lipids, Inc.

86 2Avatar Corporation

87 5B. Braun Medical

88 4B.Braun

89 24BASF

90 1BASF Corp

91 3BD RX INC

92 2BEDFORD LABS

93 1BENE PHARMACHEM GMBH AND CO KG

94 1BK Giulini GmbH

95 1Banner Pharmacap

96 1Bausch & Lomb Incorporated

97 1Bausch Health

98 4Baxter Healthcare Corporation

99 97Bayer AG

100 6Beckman Coulter

101 1Bell Flavors & Fragrances

102 2Bidachem

103 2Biocon

104 1Biomed

105 1Biosearch Life

106 25Boehringer Ingelheim GmbH

107 1Borregaard

108 4Bracco

109 2Bridgechem

110 50Bristol Myers Squibb

111 1Brookhaven national laboratory

112 2Buchler GmbH

113 1CARBOGEN AMCIS AG

114 1CHEMSPEC CHEMICALS PVT LTD

115 1CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORP

116 1CMP Pharma, Inc.

117 3COLORCON INC

118 10COSMA S.p.A

119 1CP Pharm

120 1CSL

121 1CULTOR FOOD SCIENCE INC

122 1CUSTOM CHEMICAL SOLUTIONS

123 1Cadila Pharmaceuticals

124 31Cambrex Corporation

125 5Catalytica

126 1Cebal

127 10Celanese

128 1Cerbios-Pharma SA

129 1Changzhou Pharmaceutical Factory

130 2Chattem Chemicals, Inc

131 3Chemi SpA

132 1Cheminova AS

133 1Chemtrade Solutions LLC

134 5Chugai Pharmaceutical

135 1Church & Dwight Co

136 18Cilag AG

137 17Cipla

138 1Columbia University

139 1Compañía Casco

140 3Concordia Labs Inc

141 1Contract Coating

142 4Copperhead Chemical Company

143 1Corbion

144 12Corden Pharma Bergamo S.p.A

145 3Curia

146 11Cyclo Industries

147 1Cyclo Therapeutics

148 1CytRx Corporation

149 1DAITO CORP

150 1DFE Pharma

151 1DISHMAN NETHERLANDS B.V.

152 24DMFs Not Supported

153 2DOTTIKON EXCLUSIVE SYNTHESIS AG

154 1DPT Laboratories, Ltd

155 1DURAMED PHARMS BARR

156 1Daewoong Pharmaceutical

157 22Daiichi Sankyo

158 3Daiwa Pharmaceuticals

159 1David Michael Co

160 3Delta Synthetic Co. Ltd

161 1Desitin Arzneimittel

162 10Dipharma

163 1Dolder AG

164 28Dupont

165 1Dynamit Nobel GmbH Explosivstoff- und Systemtechnik

166 14EASTMAN KODAK

167 1EMD Millipore Corporation

168 1ERIMOS TECHNOLOGIES LLC

169 9EURAND

170 1EURAND INC

171 1EXPANSIA

172 9Eastman Chemical Company

173 2Eisai

174 1Elanco

175 33Eli Lilly

176 12Erregierre SpA

177 1Esschem

178 2Esteve Quimica

179 82F. Hoffmann-La Roche

180 24F.I.S. Fabbrica Italiana Sintetici

181 2FALK & Co

182 4FDC

183 1FMC Health and Nutrition

184 5FMCCorporation - ICG

185 1FUKUZYU PHARMACEUTICAL CO LTD

186 1Farmacapsulas

187 1Farmitalia

188 1Farmson Pharmaceutical Gujarat Pvt Ltd

189 1Fermenta Biotech Limited

190 7Ferring Pharmaceuticals

191 3Fine Organics

192 1Finzelberg GmbH & Co. KG

193 1Firmenich

194 5Fison

195 1Flow Pharma

196 20Forest Laboratories

197 1Fort Dodge Australia Pty Limited AU 2150 Penrith

198 1Franco-Indian Pharmaceuticals Private Limited

199 1Fresenius Kabi AB Brunna

200 1Fresenius Kabi AG

201 1Fresenius Kabi USA

202 1Fuji Chemical Industry

203 93Fujifilm Diosynth Biotechnologies

204 1Fujifilm holding

205 1Future Pak

206 1G&W Laboratories

207 3G.D. Searle LLC US 10017 New York City

208 6GD Searle LLC

209 10GE Healthcare Inc

210 1GEA Pharma Systems

211 62GSK

212 1GUARDIAN CHEMICALS INC.

213 2GUERBET

214 1GULF OIL Corporation Limited IN 500 018 Hyderabad

215 20Gattefosse

216 24Gedeon Richter

217 1Genentech

218 2Gilead Sciences

219 2Giuliani

220 1Givaudan-Lavirotte

221 1Glatt Air Techniques

222 9Grace

223 1Grunenthal

224 1Grupo Juste

225 2Guangzhou Pharmaceutical Holding Limited

226 8Gyma Laboratories of America, Inc.

227 7H. Lundbeck AS

228 3HARTINGTON PHARMACEUTICAL

229 2HESS & CLARK INC

230 1HILL DERMACEUTICALS INC

231 1Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd

232 2Helsinn Advanced Synthesis

233 13Henkel AG & Co. KGaA

234 1Heraeus Holding

235 1Herbrand PharmaChemicals GmbH

236 10Hercules Pharmaceuticals

237 3Heumann

238 1Hexcel Corporation

239 1Hikma Pharmaceuticals

240 2Hospira, Inc.

241 6Hovione

242 3Huhtamaki

243 3INOLEX CHEMICAL CO

244 1INSTITUTO MASSONE S A

245 3INTERNATIONAL SPECIALTY PRODUCTS

246 2IOI Oleo GmbH

247 2ISP Chemicals, LLC

248 2ISP Sutton Laboratories

249 1Inalco SpA

250 4Indena

251 33Industriale Chimica

252 1Ingredion Pharma Solutions

253 5Innophos, Inc.

254 1Innovation Pharmaceuticals

255 1Intermountain Healthcare

256 16International Flavors and Fragrances

257 1Interpharm

258 2Island Pharmaceuticals

259 2Ivers-lee

260 1J.B.Chemicals & Pharmaceuticals

261 1JM Huber Corporation

262 5JRS Pharma

263 1Jacobus Pharmaceutical Company, Inc

264 1Jagsonpal

265 1Johnson & Johnson

266 18Johnson & Johnson Innovative Medicine

267 1KANEKA AMERICA CORP

268 1KYORIN PHARMACEUTICAL CO LTD

269 1Kalsec

270 1Karolinska Development AB

271 3Katwijk Chemie

272 4Key Pharmaceuticals

273 1Klinge Chemicals Ltd

274 5Kolmar Korea Co., Ltd.

275 5Kongo Chemical Co., Ltd.

276 2Kothari Phytochemicals & Industries

277 1Kremers Urban Pharmaceuticals

278 2Krka

279 23Kyowa Hakko Bio

280 2Kyowa Pharma Chemical Co Ltd

281 1LOS ALAMOS NATIONAL LABORATORY DEPT ENERGY

282 5Labochem Ltd

283 1Laboratori Derivati Organici

284 3Laboratorio Chimico Internazionale Spa

285 38Laboratorio Syntex S.A

286 1Lannett Company, Inc.

287 2Lark laboratories

288 7Lek Pharmaceuticals

289 4Leo Pharma

290 4Lonza Capsugel

291 9Lonza Group

292 11Lonza Inc & Lonza America Inc

293 3Lubrizol Life Science Health

294 11Lusochimica

295 7Lycored

296 1Lyne Laboratories

297 1LyondellBasell

298 1MDS NORDION

299 2MERCK & CIE

300 1Magle Chemoswed

301 74Mallinckrodt Pharmaceuticals

302 2Maprimed

303 1Markem Imaje

304 2Massachusetts General Hospital

305 1Matrix Pharmaceutical Inc

306 1Mayo Clinic

307 4McNeil Consumer Health

308 1Meda Pharmaceuticals Inc.

309 24Medimpex

310 8Meiji Seika Pharma

311 74Merck & Co

312 6Merck Group

313 1Merck Sante SAS

314 10Merck Serono

315 1Microbio Solutions

316 1Microchem SRL

317 16Mitsubishi Corporation

318 40Mitsubishi Tanabe Pharma

319 2Morton Salt

320 1Mundipharma

321 1NISSHIN PHARMA INC

322 2NORDIC SYNTHESIS AB

323 3NOVOPHARM LTD

324 21Napp Technologies

325 1National Institute on Drug Abuse

326 7National Institutes of Health

327 1New England Discovery Partners (NEDP)

328 1Niacet b.v

329 1Nihon Nohyaku

330 9Nippon Kayaku

331 1Nippon Rikagaku Yakuhin

332 1Nissei Corporation

333 3Nitto Denko Avecia

334 7Nordion Canada

335 1Nordmark Arzneimittel GmbH & Co. KG

336 14Novartis Pharmaceuticals Corporation

337 15Novo Nordisk

338 1Nycomed Austria GmbH

339 1OKAMI CHEMICAL INDUSTRY CO LTD

340 20ORGAMOL PHARMA SOLUTIONS SA

341 13ORGANICA Feinchemie GmbH Wolfen

342 7Olon S.p.A

343 2Organon

344 5Otsuka Chemical Co Ltd

345 1PALL CORP

346 2PCA - Prodotti Chimicie Alimentari S.p.A

347 2POLI INDUSTRIA CHIMICA SPA

348 1PRAGMA PHARMS LLC

349 6PROCTER AND GAMBLE

350 1PT KIMIA FARMA PERSERO TBK

351 1Palisade Bio

352 2Par Pharmaceutical

353 1Patheon

354 12Peninsula Laboratories

355 4PerkinElmer

356 1Perrigo Company plc

357 130Pfizer Inc

358 1Pharmaceutical Research Institute

359 1Pharmachemie

360 1Pharmacosmos AS

361 1Pharmaderm

362 3Pierrel

363 19Plantex Ltd.

364 5Pliva Hrvatska

365 3Pohl Boskamp

366 2Polysciences

367 9Procos

368 2Productos Quimicos Naturales

369 1Proquimes

370 2Puerto Rico Science, Technology & Research Trust

371 2Purdue Pharmaceuticals L.P

372 1Purolite

373 6Qualicaps

374 1Quality Chemical Laboratories

375 13Quimica Sintetica

376 1R. Mason Chemicals Limited

377 1RELIANCE CELLULOSE PRODUCTS LTD

378 22RHODIA INC US 08512-7500 Cranbury

379 1RIVOPHARM SA

380 20RP SCHERER GMBH & CO. KG

381 4Reckitt Benckiser

382 15Recordati

383 4Regis Technologies

384 3Reliable Biopharmaceutical Corporation

385 1Reliable Chemicals

386 1Rhodia Organique SAS

387 1Robinson Brothers

388 15Roche Diagnostics GmbH

389 1Roman Industries

390 8Roquette

391 1Royal DSM

392 6Ruetgers Nease Chemical

393 3S.C. POLIPHARMA INDUSTRIES S.R.L.

394 15SAFC

395 12SALSBURY CHEMICALS INC

396 3SHIN-ETSU

397 1SI Group

398 129SIGMA TAU

399 35SIMS Srl

400 2SOCIETE INDUSTRIELLE DES OLEAGINEUX

401 1SOLVAY -Technology Solutions

402 2STARKS ASSOC INC

403 3STEPAN SPECIALTY PRODUCTS LLC

404 7Salk Institute

405 1San Fu Chemical

406 39Sandoz B2B

407 2Santen Pharmaceutical

408 1Sanwa Chemical Industrial

409 1Sartorius Stedim Biotech

410 1Sato Yakuhin Kogyo Co., Ltd

411 1Schmid & Son Packaging

412 1Schütz & Co GmbH & Co DE 20095 Hamburg

413 2Scientific Protein Lab

414 5Sekisui Medical Co. Ltd

415 1Serumwerk Bernburg

416 1Shandong Xinhua Pharmaceutical

417 9Shionogi

418 5Showa Denko

419 1Showa Kako

420 2Sicor Societa Italiana Corticosteroidi Srl

421 89Siegfried AG

422 14Sifavitor srl

423 7Sigma-Aldrich Corporation

424 2Signa S.A. de C.V.

425 1Sinclair Research

426 1Sinotherapeutics

427 1Solara Active Pharma Sciences

428 1Solmag

429 11Solvay Chemicals International S.A

430 1Southern Research

431 2Southwest Synthetic Pharmaceutical

432 10Stepan Company

433 1Steri-Med Pharma

434 5Steroid SpA

435 3Stiefel

436 1Strem Chemicals

437 1Stuart Therapeutics

438 7Sumitomo Chemical

439 1Sun Pharmaceutical Industries Limited

440 3Syensqo

441 4Symrise

442 1Synder Manufacturing

443 5Synthelabo Tanabe Chimie

444 3TAYLOR PHARMACEUTICALS

445 1TCI America

446 1Taiho Pharmaceutical

447 1Taisho Pharmaceutical

448 2Takasago International

449 14Takeda Pharmaceutical

450 1Tastepoint by IFF

451 1Teikoku Seiyaku Co., Ltd.

452 1Tek Products & Services

453 1Tekni-Plex Europe

454 2Temmler Pharma GmbH & Co. KG

455 38Teva API

456 1Teva Pharmaceutical Industries

457 1Thatcher Group

458 6The Division of Cancer Treatment and Diagnosis

459 92The Dow Chemical Company

460 1The Hygenic Corporation

461 2The Mosaic Company

462 1The University of Texas MD Anderson Cancer Center

463 4Tokuyama Corporation

464 1Tokyo Chemical Industry

465 10Trifarma

466 2Trinity Tek

467 1Tsujimoto Chemical

468 14UCB Pharma S.A

469 2UNILEVER CANADA INC.

470 1UNIV MISSOURI RESEARCH REACTOR CENTER

471 1UQUIFA

472 2Ungerer and Company

473 8Unichem Laboratories Limited

474 4Union Carbide Corporation

475 1Upsher-Smith Laboratories

476 9Vanderbilt Minerals, LLC

477 1Vega Biotech Pvt. Ltd.

478 1Vertellus

479 2Viatris

480 1Viking Therapeutics

481 1Virginia Dare

482 1Wacker Chemie AG

483 7Waitaki Biosciences

484 2Weddel Limited

485 2West Pharmaceutical Services

486 3Wheaton

487 5Worthington Biochemical Corporation US 08701 Lakewood

488 25Wyeth Pharmaceuticals Inc

489 1Xttrium Laboratories

490 4YUNG ZIP CHEMICAL INDUSTRIAL

491 2Yamamoto Corporation

492 1Yangzhou Pharmaceutical

493 2Yonezawa Hamari Chemicals\

494 4Yuki Gosei Kogyo

495 6Zambon Switzerland

496 21elm-plastic GmbH

497 1608Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-03

Pay. Date : 2013-02-13

DMF Number : 1516

Submission : 1970-04-23

Status : Active

Type : II

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 365

Submission : 1960-03-03

Status : Inactive

Type : IV

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1246

Submission : 1968-10-23

Status : Inactive

Type : II

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 780

Submission : 1964-02-07

Status : Inactive

Type : II

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 575

Submission : 1963-06-05

Status : Inactive

Type : II

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 405

Submission : 1960-10-27

Status : Inactive

Type : II

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 404

Submission : 1960-10-27

Status : Inactive

Type : II

Sanofi Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 384

Submission : 1960-07-05

Status : Inactive

Type : II

Sanofi Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-13

DMF Number : 1413

Submission : 1969-09-02

Status : Active

Type : II

Pfizer centreOne

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-06

Pay. Date : 2013-02-14

DMF Number : 1418

Submission : 1969-09-04

Status : Active

Type : II

Pfizer centreOne