Latest News

6 FDA CDER quality inspections posted in last 60 days

This is updated weekly with the latest FDA inspections.

Company City Country Inspection End Date Project Area Classification
Qingdao BAHEAL Pharm Qingdao CN 2019-12-06 Drug Quality Assurance VAI
InvaGen Pharmaceutic Hauppauge US 2019-12-06 Drug Quality Assurance VAI
Apicore US LLC Somerset US 2019-12-09 Drug Quality Assurance NAI
STRIVE PHARMACEUTICA East Brunswick US 2019-12-06 Drug Quality Assurance NAI
Transdermal Delivery Palm Beach Gardens US 2019-12-03 Drug Quality Assurance VAI
Roberts Oxygen Compa Gaithersburg US 2019-12-12 Drug Quality Assurance VAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Jajco Inc. dba Anchor Drugs Pharmacy California, USA 2019-12-06
Avenue Pharmacy Inc. dba Pathway Pharmacy Florida, USA 2019-12-06
Sun Pharmaceutical Industries Ltd. India 2019-12-13

Latest FDA warning letters below, this is updated weekly with the latest FDA warning letters.

Company Issue Date Office Link
Huaian Zongheng Bio- 2020-01-09 Center for Drug Evaluation and Research | CDER
James Findling 2019-12-31 Center for Drug Evaluation and Research | CDER
Cosmelab Co Ltd 2020-01-09 Center for Drug Evaluation and Research | CDER
GOJO Industries Inc 2020-01-17 Division of Pharmaceutical Quality Operations III
Zhuhai Aofute Medica 2020-01-09 Center for Drug Evaluation and Research
Swagath Home Foods L 2020-01-07 Division of West Coast Imports

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
AMTA oral propranolol hydrochloride 60MG ANDA 2020-01-06
AMTA oral propranolol hydrochloride 80MG ANDA 2020-01-06
AMTA oral propranolol hydrochloride 120MG ANDA 2020-01-06
AMTA oral propranolol hydrochloride 160MG ANDA 2020-01-06
SUN PHARM oral omega-3-acid ethyl esters 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS ANDA 2020-01-09
CIPLA oral pregabalin 25MG ANDA 2020-01-10
CIPLA oral pregabalin 50MG ANDA 2020-01-10
CIPLA oral pregabalin 75MG ANDA 2020-01-10
CIPLA oral pregabalin 100MG ANDA 2020-01-10
CIPLA oral pregabalin 150MG ANDA 2020-01-10
CIPLA oral pregabalin 200MG ANDA 2020-01-10
CIPLA oral pregabalin 225MG ANDA 2020-01-10
CIPLA oral pregabalin 300MG ANDA 2020-01-10
ALEMBIC PHARMS oral tizanidine hydrochloride EQ 2MG BASE ANDA 2020-01-13
ALEMBIC PHARMS oral tizanidine hydrochloride EQ 4MG BASE ANDA 2020-01-13
ALEMBIC PHARMS oral tizanidine hydrochloride EQ 6MG BASE ANDA 2020-01-13
TORRENT topical clobetasol propionate 0.05% ANDA 2019-12-30
AJANTA PHARMA L oral valganciclovir hydrochloride 50MG/ML ANDA 2020-01-13
APOLLO injection dihydroergotamine mesylate 1MG/ML ANDA 2020-01-07
SOMERSET THERAP injection succinylcholine chloride 20MG/ML ANDA 2020-01-15
STI PHARMA LLC injection thiotepa 15MG/VIAL ANDA 2020-01-10
APOTEX injection tranexamic acid 100MG/ML ANDA 2020-01-14
HUONS spinal bupivacaine hydrochloride 0.75% ANDA 2019-12-30
AMNEAL PHARMS L rectal mesalamine 1GM ANDA 2020-01-02
AMNEAL PHARMS L oral pyridostigmine bromide 60MG/5ML ANDA 2020-01-10
INVATECH oral pyridostigmine bromide 60MG/5ML ANDA 2020-01-09
POLYGEN PHARMS oral darifenacin hydrobromide EQ 7.5MG BASE ANDA 2020-01-06
POLYGEN PHARMS oral darifenacin hydrobromide EQ 15MG BASE ANDA 2020-01-06
ANI PHARMS INC oral potassium citrate 10MEQ ANDA 2020-01-14
ANI PHARMS INC oral potassium citrate 15MEQ ANDA 2020-01-14
ICHNOS oral deferasirox 125MG ANDA 2020-01-06
ICHNOS oral deferasirox 250MG ANDA 2020-01-06
ICHNOS oral deferasirox 500MG ANDA 2020-01-06
MYLAN oral bosentan 62.5MG ANDA 2020-01-15
MYLAN oral bosentan 125MG ANDA 2020-01-15
PIRAMAL HLTHCAR oral deferasirox 90MG ANDA 2019-12-30
PIRAMAL HLTHCAR oral deferasirox 360MG ANDA 2019-12-30
SUN PHARM oral deferasirox 90MG ANDA 2020-01-02
SUN PHARM oral deferasirox 360MG ANDA 2020-01-02
INDOCO REMEDIES oral febuxostat 40MG ANDA 2019-12-30
INDOCO REMEDIES oral febuxostat 80MG ANDA 2019-12-30
MSN oral febuxostat 40MG ANDA 2019-12-30
MSN oral febuxostat 80MG ANDA 2019-12-30
APPCO oral haloperidol 0.5MG ANDA 2020-01-08
APPCO oral haloperidol 1MG ANDA 2020-01-08
APPCO oral haloperidol 2MG ANDA 2020-01-08
APPCO oral haloperidol 5MG ANDA 2020-01-08
APPCO oral haloperidol 10MG ANDA 2020-01-08
APPCO oral haloperidol 20MG ANDA 2020-01-08
GRANULES PHARMS oral acetaminophen; hydrocodone bitartrate 325MG;5MG ANDA 2020-01-03
GRANULES PHARMS oral acetaminophen; hydrocodone bitartrate 325MG;7.5MG ANDA 2020-01-03
GRANULES PHARMS oral acetaminophen; hydrocodone bitartrate 325MG;10MG ANDA 2020-01-03
INVATECH oral tolterodine tartrate 1MG ANDA 2019-12-30
INVATECH oral tolterodine tartrate 2MG ANDA 2019-12-30
ALEMBIC PHARMS oral vilazodone hydrochloride 10MG ANDA 2020-01-10
ALEMBIC PHARMS oral vilazodone hydrochloride 20MG ANDA 2020-01-10
ALEMBIC PHARMS oral vilazodone hydrochloride 40MG ANDA 2020-01-10

List of new API DMFs (drug master files) from FDA which is updated quarterly

Company Submit Date Subject
CADILA HEALTHCA 2019-12-31 ENZALUTAMIDE (PROCESS II)
AURORE LIFE SCI 2019-12-31 OXCARBAZEPINE USP
CADILA HEALTHCA 2019-12-31 IMATINIB MESYLATE (PROCESS II)
MSN LIFE SCIENC 2019-12-31 PENICILLAMINE USP
RA CHEM PHARMA 2019-12-24 Hydralazine Hydrochloride USP
RA CHEM PHARMA 2019-12-24 Posaconazole
DR REDDYS LABOR 2019-12-31 EDARAVONE
LUPIN LTD 2019-12-31 LEDIPASVIR
MAITHRI DRUGS P 2019-12-21 DIVALPROEX SODIUM USP
CHANGZHOU PHARM 2019-12-26 RIVAROXABAN
BRIGHTGENE FERM 2019-12-23 ANSAMITOCIN P-3
AURORE LIFE SCI 2019-12-19 DESVENLAFAXINE SUCCINATE
SOLARA ACTIVE P 2019-12-30 SUGAMMADEX SODIUM
GLAND PHARMA LT 2019-12-31 ERYTHROMYCIN LACTOBIONATE
GLAND PHARMA LT 2019-12-26 Cisatracurium Besylate
NANOPHARMACEUTI 2019-12-18 5-Aza-T-dCyd
DR REDDYS LABOR 2019-12-31 ATORVASTATIN CALCIUM TRIHYDRATE [FORM-I] [ATN PROCESS]
ZCL CHEMICALS L 2019-12-31 TICAGRELOR
FORMOSA LABORAT 2019-12-26 RUCAPARIB CAMSYLATE
ZAKLADY FARMACE 2019-12-20 Oxcarbazepine
MSN LABORATORIE 2019-12-31 LUBIPROSTONE
BIOPHORE INDIA 2019-12-28 PIMAVANSERIN TARTRATE
BIOPHORE INDIA 2019-12-31 RAMELTEON
BIOPHORE INDIA 2019-12-27 OBETICHOLIC ACID
LUPIN LTD 2019-12-09 BRIVARACETAM
DR REDDYS LABOR 2019-12-30 SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE)
SHANGHAI APPLIE 2019-12-23 HUMAN MESENCHYMAL STEM CELL MEDIUM
POLYPEPTIDE LAB 2019-12-06 TERLIPRESSIN ACETATE
SUN PHARMACEUTI 2019-12-31 DROXIDOPA
HYBIO PHARMACEU 2019-12-31 TERIPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
AURORE LIFE SCI 2019-11-30 TOLVAPTAN AMORPHOUS
AURORE LIFE SCI 2019-12-05 TOLVAPTAN
MSN LIFE SCIENC 2019-12-11 " SITAGLIPTIN PHOSPHATE ANHYDROUS"
MYLAN LABORATOR 2019-12-20 EFINACONAZOLE
MYLAN LABORATOR 2019-12-19 PENCICLOVIR
MYLAN LABORATOR 2019-12-05 MESALAMINE USP
NOVITIUM PHARMA 2019-12-17 Methyltestosterone USP
NOVITIUM PHARMA 2019-12-10 DICHLORPHENAMIDE USP
BACHEM AG 2019-12-19 Goserelin Acetate
MICRO LABS LTD 2019-12-21 Brimonidine Tartrate USP
SNJ LABS PVT LT 2019-12-10 IRON SUCROSE CONCENTRATE LIQUID
RA CHEM PHARMA 2019-11-22 VERAPAMIL HYDROCHLORIDE USP
ANQIU LUAN PHAR 2019-12-19 Acetaminophen DC90-10 SD
CIPLA LTD 2019-12-17 SALMETEROL XINAFOATE USP
ALEMBIC PHARMAC 2019-12-11 OBETICHOLIC ACID
JIANGSU HANSOH 2019-12-20 NINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE
MERCK SANTE SAS 2019-12-13 GLUCOPHAGE XR 500 mg, prolonged release tablets ? Bulk (Reduced Mass)
MSN LIFE SCIENC 2019-11-30 STIRIPENTOL
INDUSTRIALE CHI 2019-12-12 ABIRATERONE ACETATE USP (NP)
RN LABORATORIES 2019-12-11 N-octyl-1-[10-(4-octyliminopyridin-1-yl) decyl] pyridin-4-imine dihydrochloride (Octenidine Dihydrochloride)
AURORE LIFE SCI 2019-11-22 AMLODIPINE BESYLATE USP
MSN LABORATORIE 2019-12-02 TRABECTEDIN
SMS PHARMACEUTI 2019-11-26 LAMIVUDINE USP
MYLAN LABORATOR 2019-11-27 CANAGLIFLOZIN HEMIHYDRATE
MYLAN LABORATOR 2019-11-15 ABAMETAPIR
YANGTZE RIVER P 2019-11-18 TAMOXIFEN CITRATE NON-STERILE DRUG SUBSTANCE
GLAND PHARMA LT 2019-12-04 TIGECYCLINE [PROCESS ? II]
FARMHISPANIA S. 2019-12-20 EVEROLIMUS (2.0% BHT)
NEULAND LABORAT 2019-12-31 INDACATEROL MALEATE
INNOPHARMAX INC 2019-12-03 GADOTERATE MEGLUMINE
SMS PHARMACEUTI 2019-11-20 LAMOTRIGINE USP
LIVZON NEW NORT 2019-12-04 PIMAVANSERIN TARTRATE (NON-STERILE, BULK FORM)
HARMAN FINOCHEM 2019-11-19 VALSARTAN USP
ZHEJIANG SHAXIN 2019-10-31 BUPROPION HYDROCHLORIDE
AVENTACELL BIOM 2019-12-13 ULTRAGRO - PURE GI
VAMSI LABS LTD 2019-11-14 HALOPERIDOL USP
HETERO LABS LTD 2019-11-13 OBETICHOLIC ACID
CHENGDU YACHT B 2019-11-19 CASPOFUNGIN ACETATE
MSN LIFE SCIENC 2019-11-02 LIFITEGRAST
BACHEM AG 2019-11-21 ZP4207
AURISCO PHARMAC 2019-11-04 FLUTICASONE PROPIONATE (CRUDE)
SIEGFRIED EVION 2019-12-03 THREO PHENYL-2-PIPERIDIN-2-YL ACETIC ACID (RITALINIC ACID)
ZHEJIANG LIAOYU 2019-11-06 1-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-METHYLPIPERAZINE
YUNG ZIP CHEMIC 2019-11-14 RIVAROXABAN
PIRAMAL ENTERPR 2019-12-20 DROXIDOPA
ZHEJIANG GUOBAN 2019-12-07 CIPROFLOXACIN HCL 105 USP
AUDI PHARMA ING 2019-11-06 NATURAL CAPSAICIN 95% POWDER PHARMA USP GRADE
MIDAS PHARMA GM 2019-11-18 CLOFAZIMINE
AMRI ITALY SRL 2019-12-06 ROCURONIUM BROMIDE
AARTI INDUSTRIE 2019-11-15 1-{[2-(4-Chlorophenyl)-4, 4-dimethylcyclohex-1-enyl]-methyl}- piperazine dihydrochloride (VP-008)
CONCORD BIOTECH 2019-11-06 DACTINOMYCIN USP
WANBURY LTD 2019-10-31 DEXTROMETHORPHAN HYDROBROMIDE
MSN LIFE SCIENC 2019-10-31 CLOPIDOGREL BISULFATE USP FORM II
CHENGDA PHARMAC 2019-11-05 ABT74
OLON SPA 2019-12-27 CRISABOROLE
GLAND PHARMA LT 2019-10-31 SUGAMMADEX SODIUM
HOVIONE FARMACI 2019-12-20 ACLIDINIUM BROMIDE MICRONIZED
MYLAN LABORATOR 2019-11-01 PYRAZINAMIDE USP
MYLAN LABORATOR 2019-12-03 SODIUM FERRIC GLUCONATE COMPLEX
MYLAN LABORATOR 2019-11-27 PLECANATIDE
TEIJIN PHARMA L 2019-11-01 TEI-R04969 DRUG SUBSTANCE
HETERO DRUGS LT 2019-10-30 Varenicline Tartrate
ZHEJIANG JIANGB 2019-12-10 LEVETIRACETAM
HOVIONE FARMACI 2019-11-14 MINOCYCLINE
PCAS 2019-11-27 Estetrol Monohydrate
SICHUAN QINGMU 2019-11-06 TICAGRELOR
BIOPHORE INDIA 2019-12-03 NIMODIPINE
BIOPHORE INDIA 2019-12-17 Sincalide
SUN PHARMACEUTI 2019-11-06 CABOZANTINIB-S-MALATE
MANKIND PHARMA 2019-11-22 HALOPERIDOL USP
MAPRIMED SA 2019-12-18 NITAZOXANIDE
DISHMAN CARBOGE 2019-12-17 CHOLECALCIFEROL USP
ALEMBIC PHARMAC 2019-11-20 VENETOCLAX
SUN PHARMACEUTI 2019-12-16 ALECTINIB HYDROCHLORIDE
TIANJIN TIANYAO 2019-12-17 Fluticasone propionate USP
EMMENNAR PHARMA 2019-12-11 (S)-(+)-2-AMINOBUTYRAMIDE HYDROCHLORIDE
CIPLA LTD 2019-11-15 DOLUTEGRAVIR SODIUM PROCESS A
TIANJIN TIANYAO 2019-12-17 MOMETASONE FUROATE MONOHYDRATE BULK API
NEKTAR THERAPEU 2019-12-13 NKTR-255 DRUG PRODUCT
SUNNY PHARMTECH 2019-12-31 PHYTONADIONE, USP
AURISCO PHARMAC 2019-12-27 16 BETA METHYL EPOXIDE
SCINOPHARM TAIW 2019-10-31 SUGAMMADEX SODIUM
OPTIMUS DRUGS P 2019-11-07 OBETICHOLIC ACID
AVRA LABORATORI 2019-10-30 TICAGRELOR
TEVA PHARMACEUT 2019-12-26 SD-809 DEUTETRABENAZINE
FERMION OY 2019-11-20 NITROFURANTOIN MACROCRYSTAL
CHEMWERTH INC 2019-11-04 MITOMYCIN
SCI PHARMTECH I 2019-10-31 OLIVETOL
TRIS PHARMA INC 2019-11-04 KARBINAL ER (CARBINOXAMINE MALEATE) EXTENDED-RELEASE ORAL SUSPENSION EQ. TO 4 MG CARBINOXAMINE MALEATE PER 5 ML
CHENGDU SHENGNU 2019-12-13 GANIRELIX ACETATE
CURIUM US LLC 2019-12-31 64CU-DOTATATE
CURIUM US LLC 2019-12-20 COPPER CHLORIDE
HIKMA PHARMACEU 2019-10-31 HIK-078
C-SQUARED PHARM 2019-10-30 DIGOXIN (MICRON)
ZHUHAI RUNDU PH 2019-11-12 IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE
SYMED LABS LTD 2019-11-20 DEFERASIROX

Abriged, not to be used by medical professionals, updated daily from the FDA website

Company Drug Reason NDCs Date Lot Quantity

Consolidated Pharma Data Platform, see what is new over the past 30 days.

WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources. The data feeds run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.