OMUFA Facility Arrears List Friday, September 10, 2021
The following facilities have not satisfied the annual Over-The-Counter (OTC) Monograph User Fee Program (OMUFA) facility fee(s) as required under section 744M of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Coronavirus Aid, Relief, and Economic Security Act (or the “CARES Act”), under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs) as well as facility fees from qualifying manufacturers of OTC monograph drugs. The facility fee was due no later than May 10, 2021, for fiscal year (FY) 2021.
If a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded under section 502(ff) of the FD&C Act. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliate(s) in arrears (see section 744M(e) of the FD&C Act). We encourage you to seek verification from your business partners that all applicable fee(s) have been received in full by the Agency.
If your records indicate that an FY 2021 OMUFA facility fee was previously submitted, please contact [email protected] and provide the following information: • Facility Name • Dun & Bradstreet (DUNS) number • FDA Establishment Identifier (FEI) Number • User Fee Payment I.D. Number (PIN) • Payment method, date, and amount
Additionally, if you believe that your facility is not subject to OMUFA facility fees, please contact [email protected] and provide a brief explanation for your reasoning. The Agency will review your explanation and respond to it promptly.
FACILITY NAME FEI FY 2021 DUNs Number Number 3ACTLAB 3014652040 MDF 687320221
4E GLOBAL SAPI DE CV 3010078513 MDF 812821307
7774672 CANADA INC DBA DERME & CO 3008917133 MDF 203095039
A2Z PRODUCTS LLC 3014832963 MDF 098609708
ACCEL INC 3003042119 MDF 838933430
ACINO PRODUCTS LIMITED LIABILITY COMPANY 3004723334 CMO 019385518
ACTIV OZONE (PTY) LTD 3013846005 MDF 539181712
ACTIVE INTELLIGENCE LLC 3014556381 MDF 080416593
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 1 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number AD BIOTECH COLTD 3010239672 MDF 688713049
ADNOVA HEALTHCARE PRIVATE LIMITED 3015593855 MDF 876818471
AEROSOLES FRANCOMEXICANOS SA DE CV 3017570662 MDF 951582146
AESTHETIC PLUS COMPANY LIMITED 3005753252 MDF 660736328
AFASSCO INC 1000122702 MDF 956159800
AG INTERNATIONAL 3015667121 MDF 675480459
AGRICULTURAL CORPORATION SKY&LAKE 688995097 MDF 688995097
AIPC GLOBAL INC 3017136033 MDF 109839111
AJOU MEDICS CO LTD 3010165608 MDF 688796473
AJU COSMETIC CO LTD 3013427100 MDF 689847363
ALBEK DE MEXICO SA DE CV 3009115034 MDF 812321107
* ALCON - COUVREUR 3002037047 MDF 370205429
ALIVE 2 DIVE COMPANY LIMITED 3016453477 MDF 662332223
ALL PHARMA LLC 3017181385 CMO 117605075
ALL PHARMA LLC 3010047167 CMO 078572520
ALMIL NUTRITIONAL PRODUCTS INC 1000125228 MDF 153736301
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 2 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ALOE VERA KOREA COLTD 3014810945 MDF 687773350
ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET 3012382398 MDF 502657469 ANONIM SIRKETI
AMAROS CO LTD 3010518986 MDF 690338801
AMERICAN CHEMICAL SYSTEMS II LLC 3016795059 MDF 016631058
AMO (HANGZHOU) CO LTD 3004178847 MDF 420130676
AN CO LTD 3003092574 MDF 688448454
ANC 3018319069 MDF 557791697
ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO LTD 3012965155 MDF 527929527
ANNE COSMETICS 3010811600 MDF 690377762
APHARM CO LTD 689054266 MDF 689054266
ARG LABORATORIES INC 1000306124 CMO 117433599
ART NOUVEAU 3010165614 MDF 557796198
ASAN C&S 3009453181 MDF 631139649
ASANUMA CORPORATION 3007012465 CMO 715464975
ASANUMA CORPORATION 3010960168 CMO 715464942
ASHAHI CHEMICALS USA LLC 3017483558 MDF 111671300
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 3 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ASISTBOYA KIMYA VE MAKINA SANAYI TICARET 595972538 MDF 595972538 LIMITED SIRKETI
ASTRAL DEL NOROESTE SA DE CV 3002794020 MDF 814334751
ATEC CO LTD 3012259450 MDF 689276681
ATLAS R&D INC 3010515816 MDF 257836242
AURA COSMETICS INC 3017124329 MDF 696073832
AURELIO MUNOZ SAGAON 3017555570 MDF 951578972
AVADIM HEALTH INC 3006274377 MDF 041443877
AVAJAR CO LTD 3013411273 MDF 689851644
AVASOL LLC 3014630458 MDF 078822898
AVLON INDUSTRIES INC 3007090726 MDF 121278626
AVP LABS AND INVESTMENT GROUP LLC 3016822800 MDF 117579838
BAPS SWAMINARAYAN HERBAL CARE A UNIT OF DIVINE 3004290879 MDF 921183294 ENERGY
BASTON INDUSTRIA DE AEROSSOLS LTDA 3012362424 MDF 897727605
BAYSCIENCE FORMULATORS LLC 3006210508 MDF 162930544
BBC INC 3017706037 MDF 694608131
BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO LTD 656368622 MDF 656368622
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 4 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number BEIJING RIMENG BIOBOGIC TECHNOLOGY CO LTD 3005660579 MDF 527007423
BEIJING TAIJI JIN KANG MEDICAL TECHNOLOGY CO LTD 3016755317 MDF 554530728
BENXI BAICHUAN PHARMACEUTICAL CO LTD 3015234520 MDF 554466418
BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI 3012452871 CMO 533135007
BERLIN PHARMACEUTICAL INDUSTRY COMPANY 3011953233 MDF 661748158 LIMITED - BRANCH
BINOTEC CO LTD 689840563 MDF 689840563
BIO EARTH MANUFACTURING (PTY) LTD 3014120086 MDF 639768436
BIOGENESIS INC 3004933570 MDF 069117328
BIOMYLZ PVT LTD 3013697420 CMO 675466955
BIOSTECH CO LTD 3012845783 MDF 687294330
BIOTEK INDIA 3015394334 MDF 675484458
BLUE POWER GROUP LTD 3005301726 MDF 873273767
BLUE SEA AEROSOL & DAILY CARE CO LTD 3014499397 MDF 544373091
BMC 1092INC DBA SOLO LABORATORIES INC 3003087073 CMO 078831987
BMONUMENT CO LTD 3014357926 MDF 694624625
BOCCHI LABORATORIES 3008006558 MDF 013579387
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 5 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number BOSTON NUTRACEUTICAL PRODUCTION SL 3014417356 MDF 468121064
BOYA BIOTECHNOLOGY COMPANY LIMITED 3015538858 MDF 403701144
BPS 60 3008238035 MDF 272259304
BR 3013716261 MDF 689605100
BRCOSMETIC 3018544870 MDF 695596476
BRILLIANT 690381938 MDF 690381938
BSK GRUP KIMYA SANAYI VE TICARET LIMITED SIRKETI 3017679590 MDF 595676471
BSOLVE LIMITED 3008847596 MDF 734555951
BTC TOP INC 3017224474 CMO 113123620
BUENO MEDITECH 695687664 MDF 695687664
C&T DREAM CO LTD 3013632824 MDF 694699750
C&TECH CORPORATION 3007420167 MDF 688204698
C3 CO LTD 3011316036 MDF 689846633
CALFARME SINGAPORE PTE LTD 3014275859 MDF 595222746
CAMPUSORG TURIZM ORGANIZASYON REKLAMCILIK 3016783508 MDF 519903395 PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
CARING JAPAN INC 3007876103 MDF 702171786
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 6 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number CARROLLCLEAN LLC 1611690 MDF 081222623
CELBLOS DERMAL RESEARCH CENTRE PRIVATE LIMITED 3010024807 MDF 659110811
C'ELLA CO LTD 3010858038 MDF 692745698
CELLAB CO LTD 3009426136 MDF 688195494
CENTRO INTERNACIONAL DE COSMIATRIA SAPI DE CV 3012568137 MDF 814124954
CHARMING COSMETICS CO LTD 3013068404 MDF 689935740
CHINA RESOURCES SANJIU MEDICAL & 3010533926 MDF 544695711 PHARMACEUTICAL CO LTD
CHOICE ALL NATURAL INC D 103340792 MDF 103340792
CJ LABS INC 3005656496 MDF 602459476
CLEOSLAB COLTD 3017306575 MDF 695903219
CLIENTELE INC 3012481086 MDF 085021806
COASTAL CONTRACT PACKAGING INC 3004713804 CMO 137341611
CODENATURE INC 690242086 MDF 690242086
COFRAN INTERNATIONAL CORP 1000163040 MDF 122716855
COIZ CO LTD 3014442295 MDF 688382956
COLOR DESIGN LABORATORY INC 3010779331 CMO 837941108
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 7 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number COLORFUL PRODUCTS CORP 2083633 CMO 082696105
COMPANIA FARMACEUTICA SA DE CV 3004477088 MDF 816053340
CONSOLIDATED CHEMICAL INC DBA CARE-TECH 1940465 MDF 006306674 LABORATORIES INC
CONSUMER PACKAGING GROUP INC 3006114458 MDF 612465950
COSMAX CHINA INC 3009347981 MDF 545368016
COSMESIT SRL 3015458705 MDF 339071951
COSMOCOS CO LTD 3012834651 MDF 689387376
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM 3016777559 MDF 595671824 SIRKETI
COSNINE INC 3014350719 MDF 694607163
COSON CO LTD_OSAN PLANT 3010164718 MDF 689847210
COSPRO DEVELOPMENT CORP 3005123499 MDF 785638821
CREATIVE SUPPLY SOLUTION LTD 3017984767 MDF 671473247
CU LIFESTYLE LLC 3015192460 MDF 010080461
CUSTOM RESEARCH LABS INC 3008268262 MDF 028611598
DAFFY HEALTHCARE PRIVATE LIMITED 3015464211 CMO 862586251
DAVEMED HEALTHCARE CO LTD 3008161330 MDF 529128716
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 8 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number DEBUT DEVELOPMENT LLC 3011505385 MDF 079705544
DECTRONIQUE 1984 INC 3001446810 MDF 246237945
DENTON PHARMA INC DBA NORTHWIND 3012741613 MDF 080355546 PHARMACEUTICALS
DERMAESTHETICS INC 3010239910 MDF 688384549
DERMAFIRM INC 3011576660 MDF 690171603
DERMAPHARM AS 3005947959 MDF 306036476
DERMOLAB PHARMA LTD 3003011816 CMO 245414743
DESERVING HEALTH INTERNATIONAL CORP 3012271380 MDF 202617023
DIBAR NUTRICIONAL S DE RL DE CV 3012040386 MDF 812786543
DILIGO HOLDINGS JOINT STOCK COMPANY 3015893777 MDF 555365269
DOCTOR PHARM 3017619969 MDF 695222920
DOH CENTRAL PHARMACY 1036356 MDF 829348114
DONG E E HUA MEDICAL TECHNOLOGY CO LTD 3010165716 MDF 527813247
DONGGUAN CITY DEXU TOYS CO LTD 3014508997 MDF 403382659
DONGGUAN SHUOGUO SILICONE PRODUCTS CO LTD 3012901087 MDF 544426629
DOORI COSMETICS CO LTD 3012120036 MDF 688227465
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 9 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number DR EL CO LTD 3014673605 MDF 694771074
DR FRESH LLC 3002562782 MDF 117376803
DR FRIEDMAN'S NO MORE NOSEBLEED KIT INC 3015457269 MDF 117075364
DRACELL COSMETICS CO LTD 3010685026 MDF 689605482
ECHO ON 694859667 MDF 694859667
ECOWORLD CO LTD 3016774092 MDF 688735061
EFULFILLMENT SERVICE INC 3003626440 MDF 023132306
ELAN COSMETIC COLTD 3013702874 MDF 688204926
ENDEKS KIMYA SANAYI VE TICARET ANONIM SIRKETI 3012577335 MDF 565678914
EQMAXON CORP 3004878890 MDF 557821534
ERNEST JACKSON & CO LTD 3002806922 MDF 216708602
E-SOUP CO LTD 3008932144 MDF 557805059
ESSENTIAL PHARMACEUTICAL CORP 3004843655 MDF 009960980
ESTER CO LTD 3009608854 MDF 688425766
EVAXO INTERNATIONAL INC 3013336435 MDF 003464270
EVITASOURCE INC 3012001065 MDF 839478745
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 10 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number EYESOME COLTD 3010235400 MDF 557795360
FARMAQRO SA DE CV 3010165250 MDF 588161468
FEI FAH MEDICAL MANUFACTURING PTE LTD 3003892002 MDF 628416141
FINECOS 3007386722 MDF 689604970
FISCHER PHARMACEUTICALS LTD 3003908336 MDF 600009856
FLEET LABORATORIES LTD 3002806994 MDF 217269489
FLPHARMACEUTICALS LLC 5480516 MDF 080682491
FMK LABS INC 3014253278 MDF 046383819
FNC MEDICAL CORPORATION 1000160563 MDF 849207519
FRUIT OF THE EARTH INC 3011333791 MDF 079559467
FUJIAN SHUANGFEI DAILY CHEMICALS CO LTD 3007095336 MDF 527296914
FULLER INDUSTRIES LLC 1922337 MDF 078704329
FURLEY BIOEXTRACTS SDN BHD 3008174509 MDF 534411539
GAUKE HEALTHCARE CO LTD 3006362781 MDF 544935872
GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI 3016852333 MDF 356827969 VE TICARET LIMITED SIRKETI
GENCO PROPERTIES 3014188332 MDF 079916225
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 11 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL 3014369372 MDF 505204333 MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI
GIBEST 689837540 MDF 689837540
GINNI FILAMENTS LIMITED 3012293763 MDF 650793412
GK COSMETIC CO LTD 3005498957 MDF 688477309
GLOBAL HEALTH SOLUTIONS DBA TURN THERAPEUTICS 3012147657 MDF 079695890
GLOBAL TREAT SRL 3011785267 MDF 505948710
GM HOLDINGS CO LTD 3014079604 MDF 688439958
GOLDEN CUP PHARMACEUTICAL CO LTD 3011835803 MDF 659853253
GRAXCELL PHARMACEUTICAL LLC 3013737587 MDF 080805631
GRAXCELL PHARMACEUTICAL LLC 3013178640 MDF 056556923
GREEN CROSS CORP_EUMSEONG PLANT 3013103711 MDF 689852033
GREEN GUARD FIRST AID & SAFETY 1000119077 MDF 176528040
GREEN PHARMACEUTICAL CO LTD 3013338037 MDF 688750652
GREEN WONIL CO LTD 3016866131 MDF 688442099
GROUPE MARCELLE INC 3005284405 MDF 202309647
GRUPO POGAMI SA DE CV 3014653556 MDF 812811884
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 12 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL 3018063219 MDF 951582141 AGUA SA DE CV
GUANGDONG COMFORT MEDICAL PRODUCTS CO LTD 3013632692 MDF 544507534
GUANGZHOU BAIYUNSHAN JINGXIUTANG 3006010954 MDF 654032218 PHARMACEUTICAL CO LTD
GUANGZHOU BERFLY COSMETIC CO LTD 3016866806 MDF 553098664
GUANGZHOU ERTIANTANG PHARMACEUTICAL CO LTD 3013853412 MDF 546747036
GUANGZHOU MEAYON BIOTECHNOLOGY COLTD 3017152828 MDF 554520941
GUANGZHOU XIRAN COSMETICS CO LTD 3012335869 MDF 541581239
* GUY & ONEILL INC 3010164716 MDF 037838844
HANDOCK COSMETICS CO LTD 3016629969 MDF 688037204
HANEY INC 3007353165 CMO 788699445
HANGZHOU FACECARE COSMETICS CO LTD 3008655176 MDF 545341856
HANGZHOU HYGEN HEALTH BIO-TECHNOLOGY CO LTD 3015503798 MDF 554488997
HANKOOK MEDICARE CO LTD 3013462192 MDF 694765274
HANSOLBIOTECH 3018012130 MDF 694455165
HEALTH AND NATURAL BEAUTY USA CORP 3011061274 MDF 079129688
HEALTH CHEMICAL PHARMACEUTICAL CO LTD 656344421 MDF 656344421
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 13 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number HEALTHLIFE OF USA LLC 3011258653 MDF 079656178
HEBEI HOUDE HANFANG MEDICAL DEVICES CO LTD 3008693666 MDF 544307801
HENAN DAILYGREEN TRADE COLTD 3017163780 MDF 554544781
HENAN KANGDI MEDICAL DEVICES CO LTD 3009271465 MDF 421288241
HERBION PAKISTAN PVT LTD 3006705236 MDF 645482936
HERRCO COSMETICS LIMITED 3006891458 MDF 211536385
HMP BRANDS LLC 3017618827 MDF 117688328
HNB9 CO LTD 3012027529 MDF 694434516
HONEYWELL SAFETY PRODUTS USA INC 3005664148 MDF 167518617
HUANGSHI HYGIENIC MATERIAL MEDICINE CO LTD 3005543486 MDF 527157596
HUBEI KANGZHENG PHARMACEUTICAL CO LTD 3010580682 MDF 530031426
HUIZHOU BOMEI COSMETIC CO LTD 3012603666 MDF 546012568
HUMAN AND NATURE 3011744463 MDF 557816137
HUNAN XIONG SHI PHARMACEUTICAL CO LTD 3015536887 MDF 554497403
I WORLD PHARMACEUTICAL CO LTD 3014538917 MDF 688222857
ICURE PHARMACEUTICAL INC WANJU FACTORY 3011264535 MDF 695687612
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 14 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number IMKOR LIMITED LIABILITY COMPANY 3017178676 MDF 094772617
INANO CO LTD 3016533097 MDF 694212397
INCOS COSMECEUTICA INDUSTRIALE SRL 3013547725 MDF 434933032
INDO ABADI SARI MAKMUR PT 3003055435 MDF 728715202
INNER MONGOLIA HORQIN PHARMACEUTICAL CO LTD 3015540349 MDF 548635483
INVADERM CORPORATION 3010165760 CMO 078610697
IRISTA 689523945 MDF 689523945
JAK DIVERSIFIED II INC DBA MULTI-PAK PACKAGING 3003333011 CMO 153643213
JAMOL LABORATORIES INC 2211383 MDF 045670841
JEIL HEALTH SCIENCE INC 3009177778 MDF 689851513
JEWIM PHARMACEUTICAL (SHANDONG) CO LTD 3006452789 MDF 421821000
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO LTD 3014159182 MDF 544530534
JIANGSU AIMEILI COSMETIC CO LTD 3017461219 MDF 543903077
JIANGSU HANHE DAILY CHEMICALS CO LTD 3015335086 MDF 414409758
JIANGSU SHUSHI BIOTECHNOLOGY CO LTD 3015837331 MDF 554500950
JINCOSTECH COLTD 3009733672 MDF 688484870
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 15 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number JJINDUSTRYCOLTD 3005445229 MDF 689605084
JP PACKAGING LLC 3006005783 MDF 151369456
KARATICA CO LTD 3013758201 MDF 689605545
KBOEUN PHARMACEUTICAL COLTD 3016756938 MDF 695674074
KHLEE KOREA 3012188475 MDF 631081312
KMPHARMACEUTICAL COLTD 3010164172 MDF 688679158
KOCO TRADING CO INC 3004287411 MDF 079457993
KOLMAR KOREA CO LTD 3004033751 MDF 688732723
KOMPLETE GROUP INC 1640827 MDF 858820962
KOREA CANDB 3014412715 MDF 690179687
KOREA LIFE SCIENCE COLTD 3015795684 MDF 694914835
KORU PHARMACEUTICAL 3018735695 MDF 694788172
KOSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 3010924152 MDF 644090409
KREMOINT PHARMA 918325986 MDF 918325986
KUMHO DENTAL PHARM CO LTD 3018448132 MDF 631133766
KUNMING ZHONGZHOU PHARMACEUTICAL CO LTD 3016463674 MDF 529561942
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 16 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number KWANG DUK SIN YAK CO LTD 3013658397 MDF 688202646
LAB DOUCE COSMETICS (SHENZHEN) CO LTD 3008236800 MDF 529303186
LABORATOIRES DRUIDE INC 3008226137 CMO 245815014
LABORATORIO SALUTEC SA DE CV 3017102625 MDF 951580007
LABORATORIOS BREMER SA 3003097030 MDF 811585264
* LABORATORIOS COSMODENT SL 3011042848 MDF 513012153
LABORATORIOS DR COLLADO SA 3000989764 MDF 817468001
LABORATORIOS QUIMICA SON'S SA DE CV 3012225562 MDF 815603378
LALEHAM HEALTH & BEAUTY LTD 3003276300 MDF 217105741
LALEHAM HEALTH AND BEAUTY LTD 3011463745 MDF 221477132
LE PAPILLON LTD 3012580398 MDF 040070823
LEEJIHAM 3007567231 MDF 695004132
LES EMBALLAGES FACOTECK INC 3002955163 MDF 245423439
LES ENTREPRISES STEFMAR INC 3004597672 MDF 240496385
LESJAL ENTERPRISE 3013154612 MDF 658289954
LICO INDUSTRIES LLC 3003411169 MDF 098009041
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 17 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number LIEBECOS COLTD 3014614398 MDF 689156029
LITTLES SKIN CARE INC 3014364050 CMO 058087047
* LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION 3008468946 MDF 037342305 INC
LMZ 3002895902 MDF 654623156
LONGBOW FIRST AID PRODUCTS MANUFACTORY 3006102089 MDF 529128690
LONGOOD MEDICINE BEIJING CO LTD 3011090864 MDF 529553064
LOVE LIFE PHARMACEUTICAL CO LTD 3004763377 MDF 656175338
LS COSMETIC COLTD 3013322774 MDF 557821800
LTD HANKOOKSINYAK 3010165801 MDF 689277536
LUOYANG MUCHUN PHARMACEUTICAL CO LTD 3014158124 MDF 526916382
LYDIA CO LTD 3015301033 MDF 695735569
M & C SPECIALTIES INC 2523928 MDF 002297232
MABA KOZMETIK LIMITED SIRKETI 3017971707 MDF 503001418
MAKSON HEALTHCARE PRIVATE LIMITED 3006744199 MDF 650553980
MAMIBA 3008244875 MDF 558528988
MARKWINS COSMETIC (SHENZHEN) CO LTD 3010165804 MDF 544845621
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 18 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number MARLINZ PHARMA LLC 3012816149 MDF 080251509
MEDICAL PURCHASING SOLUTIONS LLC 3014288534 MDF 601458529
MEDICELL BIO CO LTD 3016533086 MDF 689843703
MEDIQUE PRODUCTS 1833338 MDF 086911794
MEDSOURCE PHARMACEUTICALS 3007422897 MDF 833685915
MEMPHIS CONTRACT PACKAGING INC 1000132517 MDF 185390010
MICELL KOREA LAB CO LTD 689851542 MDF 689851542
MICRO CONNECTION ENTERPRISES INC THE 3003964498 MDF 144297160
MILAN LABORATORIES (INDIA) PRIVATE LIMITED 3010428147 MDF 919077177
MILBAR LABORATORIES INC 2435254 MDF 195556790
MILLA DOO 3007684927 MDF 499561413
MIRACLEAN TECHNOLOGY CO LTD 3008572203 MDF 529423940
MISOCOS 3016437527 MDF 695640173
MIZ HERB 3006219056 MDF 688216078
MOHNARK PHARMACEUTICALS INC 3015500516 MDF 117013830
MOOGOO USA LLC 3011371545 MDF 076343899
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 19 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number MORGAN GALLACHER 3004532724 MDF 028311595
MSCO CO LTD 3014646320 MDF 689039838
MSH KK 3014652031 MDF 691891271
* NADCO TAPES & LABELS INC 3012266578 MDF 181596375
NATURAL BEAUTY CARE PTY LTD 3010164028 MDF 749369716
NATURE REPUBLIC CO LTD 3010164032 MDF 631172020
NATURE4 CO LTD 3013756124 MDF 694208420
NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED 3011575694 MDF 355602127 SIRKETI
NATUZEN COLTD 3006731547 MDF 688201272
NEETA HERBAL 861989208 MDF 861989208
NEW & NEW CO LTD 3009692276 MDF 557821160
NEW LEAF PHARMACEUTICALS LLC 3006021444 MDF 080792350
NIBEC CO LTD 3007679154 MDF 687796909
NINGBO SANTE YING MEDICALAND 3015844796 MDF 404080257 HEALTHDEVELOPMENT COLTD
NINGBO YAOHU BIO-TECHNOLOGY CO LTD 3016778473 MDF 404087605
NOON AESTHETICS MR LTD 3016618147 MDF 600185560
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 20 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number NORMALEST CO LTD 3015233639 MDF 694812877
NORMED 3013226 MDF 069560969
NORTHWIND PHARMACEUTICALS LLC 1831143 MDF 036986393
NOVA NEURA LLC 3017048784 MDF 117121636
NUCARE PHARMACEUTICALS INC 3003294404 MDF 010632300
NUGGELA & SULE SL 3013595629 MDF 466134663
NUTRALIFE BIOSCIENCES INC 3009393935 MDF 078834338
O2 CLEAN 3005047201 MDF 694888055
OC QUEST INC 3014722794 MDF 055996258
OHIO LAB PHARMA 3012966715 MDF 080215854
ONA 3013222935 MDF 689851847
OPSEVE KOREA COLTD 3008551168 MDF 690048629
OPTIKA CO LTD 3013115837 MDF 688439839
OPTO-PHARM PTE LTD 3005320466 MDF 595239682
ORGANICS CORPORATION OF AMERICA DBA AMBIX 2218854 MDF 061061164 LABORATORIES
ORYE LIFE SCIENCE CO LTD 3011245684 MDF 688546629
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 21 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number OXFORD PHARMACEUTICALS LLC 3012257735 MDF 079638266
OZ NATURALS LLC 3013202438 MDF 079726946
P&P INTERNATIONAL 3005741051 MDF 133591508
PACIFIC BEACH ORGANICS CO 3018448144 MDF 117402523
PACKAGE SOLUTIONS LLC 3010142145 MDF 054705875
PACKAGING UNLIMITED LLC 3012312485 MDF 070287478
PACKAGING UNLIMITED LLC 1000149666 MDF 968826354
PACKAGING UNLIMITED LLC 3004903838 MDF 079651105
PAL MIDWEST LTD 1450165 MDF 064006521
PAN RAJDHEVEE GROUP PUBLIC COMPANY LIMITED 3003965615 MDF 659893242
PANROSA ENTERPRISES INC 3013024004 MDF 859957578
PATCOS COSMETICS (INDIA) PRIVATE LIMITED 3009250196 MDF 675973979
PEDIFIX INC 3009710062 MDF 122271935
PEER PHARM LTD 3006774077 MDF 514678390
PHARBEST PHARMACEUTICALS INC 3005382247 MDF 557054835
PHARMALOZ MANUFACTURING INC 2523447 MDF 067101998
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 22 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number PHARMAMEDRX 3015503256 MDF 063814205
PHARMANUCO 3014218940 MDF 687825097
* PHARMASERVE NORTH WEST LTD 3010166809 MDF 210141282
PHARMATURA-INDUSTRIA DE COSMETICOS LTDA 3013116409 MDF 903405397
PHARMEX GROUP LLC 3013608744 MDF 365309015
PICOSTECH COLTD 3010822334 MDF 557816754
PIOOM COSMETIC COLTD 3012769608 MDF 689605377
PLANETHEMP LLC 3017269804 MDF 077256475
POCONO COATED PRODUCTS 3011029136 MDF 362785771
POLAROISIN INTERNATIONAL CO LTD 3008004582 CMO 658727511
POLIMEROS Y SERVICIOS SA 3011778211 MDF 815740251
POND ALLIANCE INC 832675305 MDF 832675305
POWER FULX CO LTD 3013702100 MDF 689515038
PRATT (SOUTHEAST DISPLAYS) LLC 3013174316 MDF 080577750
PREVENTION HEALTH SCIENCES INC 3013151674 MDF 968930540
PRIYAL COSMETICS 3015152761 MDF 675482356
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 23 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number PRODUCTOS Y SERVICIOS DE LIMPIEZA SEGUCLEAN SA 951580477 MDF 951580477 DE CV
PROPHASE LABS INC 3003068436 MDF 620557298
PT DUALIMA INDUSTRIES 3016742766 MDF 660016902
PULCRA CHEMICALS LLC 3006459867 MDF 801182705
QUEST PHARMACEUTICALS PTY LTD 3015937307 MDF 748278991
R&R LOTION INC 3004167955 MDF 062979000
RAPID CARE INC 3016595518 MDF 877432778
RECIPE CO LTD 3011836851 MDF 631158768
RED WEDDING LLC DBA HI-HEALTH 3015415764 MDF 117181523
RENU LABORATORIES INC 3003262206 MDF 945739449
RFX PHARMACEUTICAL CO LTD 3006712336 MDF 530620871
RIDGE PROPERTIES LLC 3011007272 MDF 029478762
RIGHT SOLUTIONS CORPORATION, THE 3003110266 MDF 203855150
RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET 3017491602 MDF 520068126 ANONIM SIRKETI
* RNA PHARMA LLC 3017156960 MDF 079103999
ROSSARI BIOTECH LIMITED 3017488386 MDF 878829252
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 24 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ROYAL COSMETICS CORPORATION 1000122069 MDF 616109799
ROYAL EXPORTS 3007672035 MDF 650621381
RUBELLI COLTD 3012942748 MDF 689452000
SAFREL PHARMACEUTICALS LLC 3014704014 MDF 080566287
SAHI COSMETICS LLC 3014576610 MDF 070199057
SALONES DE BELLEZA Y EQUIPOS DE EL SALVADOR 3004422519 MDF 851242271 SOCIEDAD ANONIMA DE CAPITAL VARIABLE
SAMPLE SOLUTIONS LLC 3004198972 MDF 132970034
SAMSON PHARMACEUTICALS INC 3005644727 MDF 088169581
SANIT & SONS COMPANY LIMITED 3010474357 MDF 660220096
SANUS SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM 3016982825 MDF 533144738 SIRKETI
SANVIO INC 3016903306 MDF 100812165
SASA COSMETICS 3011441949 MDF 600481230
SCIENTIFIC SOLUTIONS GLOBAL LLC 3013847493 MDF 097291290
SELECT CORPORATION 3003727136 MDF 053805599
SHANDONG VIANOR HEALTHY SCIENCE COLTD 3017925388 MDF 554532204
SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD 3003447230 MDF 420978637
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 25 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number SHANGHAI LIANGLIANG BIO TECHNOLOGY CO LTD 3012317179 MDF 547834726
SHANGHAI MAXAM COMPANY LIMITED 3012696632 MDF 421325329
SHANGHAI ZHONGHUA PHARMACEUTICAL NANTONG CO 3007737073 MDF 420795668 LTD
SHEENCOLOR BIOTECH CO LTD 3005282679 MDF 545285306
SHIFT PACKAGING 3017103594 MDF 117559082
SHINE & PRETTY (USA) CORP 2027711 CMO 603528605
SHINSEGAE INTERCOS KOREA INC 3014316053 MDF 694526100
SICHUAN FRAGRANT PLANT BIOTECHNOLOGY CO LTD 3012522125 MDF 544412923
SILVER TECH DE MEXICO SA DE CV 3018026923 MDF 951582215
SIMPOR PHARMA SDN BHD 3011430470 MDF 586043981
SINOPHARM GROUP FENGLIAOXING (FOSHAN) 3005829311 MDF 530841720 PHARMACEUTICAL CO LTD
SKINCURE INC 3014270423 MDF 557830240
SKY SYSTEMS CO INC 1000331562 MDF 621886548
SKYLINE HERBALS PRIVATE LIMITED 3017104669 MDF 877566114
SMARTSCIENCE LABORATORIES INC 3003929069 MDF 035907919
SNOW PHARMACEUTICALS LLC 1000121478 MDF 797770294
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 26 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number SNYDER MANUFACTURING CORP 3003693777 MDF 008277501
SOFTECH PHARMA PRIVATE LIMITED 3007721548 CMO 677111277
SOLEO COSMETIC CO LTD 3009699696 MDF 557829412
SOMI T NA CO LTD 3017157304 MDF 694085583
SONOCO DISPLAY & PACKAGING LLC 1053488 MDF 129850751
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI 3012430409 MDF 366418499
SORISO 3016792479 MDF 689515253
SOTAC PHARMACEUTICALS PRIVATE LIMITED 3014454532 MDF 876894019
SPARKJD INC 3014221803 MDF 688353975
SPM CORPORATION 3006058589 MDF 555279715
SQUARE M LLC 3016463891 MDF 117467455
STANCOS PRIVATE LIMITED 3012958176 MDF 645478686
STAR COLOUR LABORATORIES 3009714782 MDF 215970015
STASINOS SIKALIAS 3014651946 MDF 363281305
STC NARA CO LTD 3016790229 MDF 689135085
STERLING PHARMACEUTICAL SERVICES LLC 3009705561 MDF 783182475
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 27 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number * STERLING PHARMACEUTICAL SERVICES LLC 3011531531 MDF 079569189
STEUART CUSTOM MANUFACTURING INC 3016626175 MDF 116952121
STEUART LABORATORIES INC 3000719826 MDF 786086462
STRUKMYER MEDICAL 3000205837 MDF 078587210
SUHAN AEROSOL 3016067439 MDF 861140760
SUITE K VALUE ADDED SERVICES LLC 3004603827 MDF 036822144
SUNASCEN THERAPEUTICS LLC 3009513531 MDF 078272834
SUNGWON COSMETIC INC 3011557342 MDF 688389506
SUNGWON PHARMACEUTICAL CO LTD 3006335969 MDF 689787898
SUNJINBIO COLTD 3016543909 MDF 695626316
SUNSTAR GUANGZHOU LTD 3009449945 MDF 544725724
SWASHES SHENZHEN CO LTD 3017077292 MDF 421263450
SYSTEM KOSMETIK PRODUKTIONSGESELLSCHAFT FUR 3011408975 MDF 328825757 KOSMETISCHE ERZEUGNISSE MBH
TAEJOON PHARM CO LTD 3008029795 MDF 689852091
TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI 3004135088 MDF 365979587 VE TICARET ANONIM SIRKETI
TECHNICHEM CORP 3012112742 MDF 007076552
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 28 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number TECOZYME INC 3017681214 MDF 694613703
TEN DAYS MANUFACTURING 3017234464 CMO 128011938
TG LABS INC 3013479261 MDF 831504621
THAI NAKORN PATANA CO LTD 3003067499 MDF 659931273
THE COSRISE COLTD 3012690230 MDF 689840253
THE GENERIC PHARMACEUTICAL COMPANY 3013565875 MDF 078787060
THE ORGANIC PHARMACY LTD 3010506863 MDF 220198688
THERANOTICS CO LTD 3016435920 MDF 694963085
TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL 3006283468 MDF 548196236 CO LTD
TIANJIN OCULAX BIOTECH INC 3012285044 MDF 542949666
TIANSHUI WEISHI TONGTAI PHARMACEUTICAL CO LTD 3013277063 MDF 544305099
TIMING PHARMACEUTICAL CO LTD PABP BRANCH 3013082576 MDF 658875012
TOPICAL DRUG MANUFACTURING LABS 3016998452 MDF 117514751
TOPICARE MANAGEMENT LLC 3012222405 MDF 079902303
TRANSFER TECHNOLOGY INC 3009494532 MDF 037968132
TROPICAL ENTERPRISES INTERNATIONAL INC 3010166225 MDF 091986179
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 29 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number TS INTERNATIONAL 3011807524 MDF 689851767
TSUKIOKA FILM PHARMA CO LTD 3005148348 MDF 693381774
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK 3009482034 MDF 356325295 KIMYASAL URUNLER
UNILEVER CHINA CO LTD 3013484973 MDF 530170948
US DRUGS INC 3017234173 MDF 104282689
US NONWOVENS CORP 3000285187 MDF 080453184
V MANE FILS 3004334539 MDF 274581214
VEGE-KURL INC 2013412 CMO 021072509
VELOCITY PRODUCTION AND PACKAGING 3004835629 MDF 081076893
VEMA INDUSTRIE-VERPACKUNG GMBH & CO KG 3014159044 MDF 316193515 KONTRAKT - ABFULLUNG UND -VERPACKUNG
VENTEX CO LTD 3007919129 MDF 688813182
VENUS KASEI CO LTD 3017956634 CMO 693553430
VESEN INC 3014659205 MDF 081059349
* VIOBIN LLC 1450618 MDF 805279234
VITACARE LABS INC 3008920776 MDF 244187550
VITAL FORMULATIONS LIMITED 3015493852 MDF 859173219
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 30 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number VITALITY WORKS INC 3000719151 MDF 137752817
VIVANT SKIN CARE LLC 3009868709 MDF 782696814
WILSON MEDICINE COMPANY 3004974700 CMO 916000287
WINNER MANUFACTURING 3010481543 MDF 561423928
WINNOVA CO LTD 3013573668 MDF 689348571
WOOIL C&TECH CORP 3010176173 MDF 688331078
WUXI HUOBAN DAILY-USE CHEMICAL SCIENCE AND 3015876231 MDF 421207374 TECHNOLOGY CO LTD
XIAMEN AFGAMARINE BIOTECHNOLOGY CO LTD 3011077382 MDF 420485152
XIAMEN TRIZ LABORATORIES LTD 3010164052 MDF 421290822
YANGZHOU H&R PLASTIC DAILYCHEMICALL CO LTD 3014543859 CMO 554455648
YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD 3013648450 MDF 560398069
YIWU HAODING MEDICAL CO LTD 3011248163 MDF 421362384
YOSUN TECH CO LTD 3016661308 MDF 656018189
YSA TRADING CO LTD 695146678 MDF 695146678
YUYAO YIJIA DAILY CHEMICAL CO LTD 3015592903 MDF 529646545
ZENITON COLTD 3015051869 MDF 688416831
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 31 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ZHEJIANG AIDI COSMETICS CO LTD 3007790619 MDF 530876820
ZHEJIANG JEANSUN COSMETICS CO LTD 3014512553 MDF 421310774
ZHEJIANG SANYI INDUSTRY CO LTD 3016994961 MDF 421143041
ZHENGZHOU DAOHE MEDICAL TECHNOLOGY COLTD 3016534411 MDF 406230407
ZHUHAI AOFUTE MEDICAL TECHNOLOGY CO LTD 3013761135 MDF 544472634
ZOONO USA LIMITED LIABILITY COMPANY 3011032188 MDF 073623478
ZORIN PHARMACEUTICAL TECHNOLOGY (HANGZHOU) CO 3017086747 MDF 554529819 LTD
ZUNYI JICI BIO-HEALTH PRODUCTS CO LTD 3015478240 MDF 540365854
* These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 32 of 32