US Drug Master Files Submitted or Reviewed Third Quarter 2016 [ for industry | Ketogenics - Lose Weight Without Exercise!]   

 
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DMF Number Status Type Submit Date Holder Subject
29606AII7/14/2016ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE HEMIHYDRATE USP
29628AII9/16/2016CIPLA LTDLENALIDOMIDE
29693AII8/16/2016SINOPEP JIANGSU INCLANREOTIDE ACETATE
29744AII8/22/2016JOHNSON MATTHEY PHARMA SERVICES4250.C
29849AII8/15/2016ALP PHARM BEIJING CO LTDVORTIOXETINE HYDROBROMIDE
29850AII8/10/2016ALP PHARM BEIJING CO LTDCLEVIDIPINE BUTYRATE
29864AII9/30/2016SUN PHARMACEUTICAL INDUSTRIES LTDAZACITIDINE
29885AII8/16/2016RHODES TECHNOLOGIES INCBUPRENORPHINE HYDROCHLORIDE, USP
29911AIV8/19/2016TOLMAR INCBIODEGRADABLE POLYMER EXCIPIENTS
29913AII8/31/2016TEVA PHARMACEUTICAL INDUSTRIES LTDDIMETHYL FUMARATE
30152AII9/23/2016NAVINTA LLCROPIVACAINE HYDROCHLORIDE USP
30156AII9/27/2016NAVINTA LLCREMIFENTANIL HYDROCHLORIDE
30161AIII8/30/2016ZIBO ZHONGNAN PLASTICS CO LTDPVC, PVC/PE, PET, PET/PE, PVC/PVDC SHEET
30176AII9/24/2016ENALTEC LABS PRIVATE LTDPHYTONADIONE USP
30249AII9/20/2016CHENGDU SHENGNUO BIOPHARM CO LTDOCTREOTIDE ACETATE USP
30261AII8/5/2016SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE
30287AII9/7/2016HONOUR LAB LTDCOBICISTAT ON COLLOIDAL SILICON DIOXIDE
30302AII10/28/2015JENKEM TECHNOLOGY CO LTD8ARM PEG SUCCINIMIDYL GLUTARATE (HEXAGLYCEROL) MW 15000
30417AII9/26/2016CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)
30429AII9/16/2016AMPHASTAR NANJING PHARMACEUTICALS INC (ANP) AN AMPHASTAR COPROTAMINE SULFATE USP
30463AII8/31/2016AMRI RENSSELAER INCOMACETAXINE MEPESUCCINATE
30466AV7/20/2016PEREGRINE PHARMACEUTICALS INCCONTRACT BIOTECHNOLOGY PRODUCT MANUFACTURING FACILITY
30471AIII9/26/2016NYPRO INCBDP BAI ACTUATOR/ MAIN BODY ASSEMBLY
30472AIII9/26/2016NYPRO INCBDP BAI ACTUATOR/ FORCE HOLDING UNIT ASSEMBLY
30487AII8/9/2016ACS DOBFAR SPASODIUM CARBONATE STERILE LYOPHILIZED
30488AII7/21/2016ACS DOBFAR SPAMEROPENEM TRIHYDRATE STERILE
30492AII9/6/2016NAVINTA LLCDS121 DRUG SUBTANCE
30498AII7/19/2016GLOCHEM INDUSTRIES LTDTOLCAPONE USP
30511A II10/5/2016MORTON SALT INCUSP POTASSIUM CHLORIDE
30526AII9/27/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDICATIBANT ACETATE
30539AII8/10/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDDOTA
30548AII9/5/2016SIGMA-ALDRICH PRODUCTION GMBHMEBROFENIN
30565AII9/17/2016MACLEODS PHARMACEUTICALS LTDPRASUGREL HYDROCHLORIDE
30566AII9/20/2016MACLEODS PHARMACEUTICALS LTDCARVEDILOL PHOSPHATE
30570AII9/28/2016JIANGSU HENGRUI MEDICINE CO LTDSEVOFLURANE USP
30577AII7/18/2016HONOUR LAB LTDALOGLIPTIN BENZOATE
30583AII8/12/2016AMBIOPHARM INCTEDUGLUTIDE NON-STERILE
30591AII8/23/2016ADARE PHARMACEUTICALS INCAR18 - APT5033 EXTENDED RELEASE ORALLY DISINTEGRATING TABLETS
30598AII8/3/2016MACLEODS PHARMACEUTICALS LTDCYCLOSERINE
30601AII7/11/2016AURISCO PHARMACEUTICAL LTD9-(2-PHOSPHONYLMETHOXYPROPYL) ADENINE (PMPA)
30602A V10/27/2016PFIZER INCPEARL RIVER ASEPTIC MANUFACTURING FACILITY
30604AII8/16/2016GRANULES INDIA LTDFEXOFENADINE HYDROCHLORIDE, USP
30605AII9/9/2016CENTROFLORA CMS SARLATROPINE SULFATE USP
30609AII9/28/2016NEULAND LABORATORIES LTDRIVAROXABAN
30613AII7/20/2016INDOCO REMEDIES LTDAPIXABAN
30614AV8/31/2016WUXI APPTEC INCSTERILE PROCESSING FACILITY AT PHILADEPHIA, PA
30617AII8/2/2016SUN PHARMACEUTICAL INDUSTRIES LTDTOFACITINIB CITRATE
30618AII7/5/2016DSM NUTRITIONAL PRODUCTS LTDASCORBIC ACID
30619AII8/12/2016MICRO LABS LTDAPIXABAN
30621AII8/3/2016MICRO LABS LTDTOFACITINIB CITRATE
30622AII7/26/2016ALKEM LABORATORIES LTDDIMETHYL FUMARATE
30630AII7/6/2016CADILA HEALTHCARE LTDAPIXABAN
30635AII7/29/2016WATSON PHARMA PRIVATE LTDAPIXABAN
30636AII7/30/2016HETERO LABS LTDLOPINAVIR (PROCESS-II)
30644AII7/9/2016SCINOPHARM TAIWAN LTDENZALUTAMIDE
30645AIII7/12/2016SIBO G DOOCHILD RESISTANT CLOSURES SIBO
30650AII7/2/2016MSN LIFE SCIENCES PRIVATE LTDCOBICISTAT ON SILICON DIOXIDE
30651AII7/5/2016DSM NUTRITIONAL PRODUCTS LTDFOLIC ACID
30652AII9/15/2016CHEMWERTH INCISOPROTERENOL HCL USP
30654AII7/5/2016UNICHEM LABORATORIES LTDTOFACITINIB CITRATE
30657A II10/11/2016MALLINCKRODT INCDEXMETHYLPHENIDATE HYDROCHLORIDE
30658AII9/27/2016NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCHCANNABIDIOL
30667AII7/20/2016UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)ESOMEPRAZOLE SODIUM
30668AII7/14/2016HETERO LABS LTDPOMALIDOMIDE
30671AII7/21/2016DELMAR CHEMICALS INCSOLIFENACIN SUCCINATE
30672AII7/25/2016MSN LIFE SCIENCES PRIVATE LTDICATIBANT ACETATE
30673AII7/21/2016DSM NUTRITIONAL PRODUCTS LTDDL-ALPHA-TOCOPHERYL ACETATE
30674AII9/22/2016ADARE PHARMACEUTICALS INCAPT-5032 EXTENDED RELEASE CAPSULES
30678AIII8/14/2016SILILABEL SABLISTER MATERIALS
30682AII7/29/2016ALKEM LABORATORIES LTDMETHYLPHENIDATE HYDROCHLORIDE USP
30683AII7/8/2016MSN LABORATORIES PRIVATE LTDBOSUTINIB MONOHYDRATE (FORM-I)
30687AII7/6/2016ALCHEM INTERNATIONAL PRIVATE LTDHYOSCINE EP (SCOPOLAMINE)
30696AII8/2/2016SYNTHON BVPOMALIDOMIDE
30697AIII7/2/2016MAXCARE DEVICESILICONE TUBING, BRAIDED HOSE PIPES, TRI-CLOVER SEALS, DIAPHRAGM, GASKETS, SHEETS AND RINGS
30704AII7/12/2016AUROBINDO PHARMA LTDAPIXABAN
30706AII7/7/2016CHILLIES EXPORT HOUSE LTDCAPSAICIN USP
30707AII7/23/2016HARMAN FINOCHEM LTDISOPROTERENOL HYDROCHLORIDE USP
30712AII8/31/2016APOTEX PHARMACHEM INDIA PVT LTDRANOLAZINE
30713AII7/29/2016TREIBACHER INDUSTRIE AGGADOLINIUM OXIDE
30714AIV9/27/2016GLAND PHARMA LTDBETADEX SULFOBUTYL ETHER SODIUM USP- NF
30716AII8/1/2016GLAND PHARMA LTDBETAMETHASONE ACETATE USP STERILE
30717AII7/16/2016HETERO DRUGS LTDAMLODIPINE BESYLATE(PROCESS-II)
30721AII7/6/2016ALCHEM INTERNATIONAL PRIVATE LTDSCOPOLAMINE HYDROBROMIDE USP
30722AII8/3/2016CIPLA LTDPALIPERIDONE
30723AII9/2/2016DSM NUTRITIONAL PRODUCTS LTDDEXPANTHENOL
30724AII7/6/2016ALCHEM INTERNATIONAL PRIVATE LTDDIGOXIN USP
30725AII7/6/2016ANTIBIOTICOS DE LEON SLUAMOXICILLIN TRIHYDRATE
30726AIII7/6/2016POLYONE CORPEM10027398XX
30727AIII7/21/2016ECLATIN AGINTERNAL PROTECTIVE LACQUER BO-A2263/S2 BPA FREE
30728AIV7/12/2016NICHIBAN CO LTDYS RESIN PX 1150NM
30730AII7/25/2016AURISCO PHARMACEUTICAL LTDTENOFOVIR DISOPROXIL FUMARATE
30732AII9/30/2016DR REDDYS LABORATORIES LTDAPREMILAST (FORM B)
30734AII9/9/2016PIRAMAL HEALTHCARE CANADA LTDAGB DRUG SUBSTANCE
30735AII7/29/2016MYLAN LABORATORIES LTDDARUNAVIR ETHANOLATE
30736AII7/20/2016GALACTIC SASODIUM (S)-LACTATE SOLUTION
30737AII8/11/2016CIPLA LTDDACLATASVIR DIHYDROCHLORIDE
30741AII7/11/2016ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE
30742AIII7/15/2016OTECH CORPTUBING AND FILM/SHEET BASED ON THERMOPLASTIC COMPOUNDS
30743AIII8/23/20163M DRUG DELIVERY SYSTEMS3M COTRANÖ 9699 TAN NONWOVEN TAPE
30744AIV9/27/2016CAPSUGEL MANUFACTURING INCEMPTY HARD GELATIN CAPSULE SHELLS
30746AII8/16/2016PERRIGO API LTDIBRUTINIB
30747AII7/19/2016SYMBIOTEC PHARMALAB PRIVATE LTDHYDROXYPROGESTERONE CAPROATE USP
30748AIV7/13/2016CREST CELLULOSE PRIVATE LTDMICROCRYSTALLINE CELLULOSE (CELLUCREST)
30749AIII7/19/2016TOYO INK CO LTDLIOALPHA S SERIES
30750AIV7/20/2016CELANESE EVA POLYMERSETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE« K2797.X01
30751AIII7/15/2016SAGAR RUBBER PRODUCTS PVT LTDALU-PLASTIC SEAL MADE OF ALUMINIUM AND PLASTIC
30752AII7/1/2016ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP
30753AII9/9/2016MACLEODS PHARMACEUTICALS LTDCANAGLIFLOZIN
30754AII9/1/2016MACLEODS PHARMACEUTICALS LTDATOMOXETINE HYDROCHLORIDE
30755AII8/17/2016MACLEODS PHARMACEUTICALS LTDNITROFURANTOIN ANHYDROUS (MACROCRYSTAL)
30756AII9/30/2016MACLEODS PHARMACEUTICALS LTDPERPHENAZINE
30758AII7/30/2016ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDPENCICLOVIR (API)
30759AII7/31/2016MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-A)
30760AII7/26/2016AVANTI POLAR LIPIDS INC1,2 -DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) (730355)
30761AII8/24/2016SASOL GERMANY GMBHPOLYETHYLENE GLYCOL (LIPOXOL MED SP)
30762AII8/4/2016RHODES TECHNOLOGIESBUPRENORPHINE
30763AV7/19/2016MICROTROL STERILISATION SERVICES PVT LTDETHYLENE OXIDE STERILISATION
30764AII7/14/2016ZAKLADY FARMACEUTYCZNE POLPHARMA SAPRASUGREL HYDROCHLORIDE
30765AII7/14/2016ZAKLADY FARMACEUTYCZNE POLPHARMA SAPRASUGREL MALEATE
30766AIV7/21/2016FONA INTERNATIONAL INC915.0348U N-C STRAWBERRY FLAVOR ART
30767AII7/15/2016BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDFONDAPARINUX SODIUM (NON-STERILE, API)
30768AII7/25/2016ROVI CONTRACT MANUFACTURING SLSTERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGE
30769AIV7/25/2016FONA INTERNATIONAL INC856.2049U FONATECH« GRAPE FLAVOR ART
30770AIV7/22/2016CELANESE EVA POLYMERSETHYLENE VINYL ACETATE COPOLYMER VITALDOSE« K2769.X01
30771AII8/30/2016MYLAN LABORATORIES LTDCANAGLIFLOZIN
30772AII8/30/2016MSN LIFE SCIENCES PRIVATE LTDELVITEGRAVIR (FORM-II)
30774AII8/10/2016SIGMAPHARM LABORATORIES LLCAPIXABAN AMORPHOUS (6.58%)
30775AII9/17/2016EMCURE PHARMACEUTICALS LTDPHYTONADIONE USP
30776AIII8/23/2016URSATEC VERPACKUNG GMBHCOMFORT-SYSTEM
30777AIV7/24/2016CELANESE EVA POLYMERSETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE« K2770.X01
30779AII8/2/2016SINOPHARM WEIQIDA DATONG PHARMACEUTICAL CO LTD6-AMINOPENICILLANIC ACID
30780AII8/1/2016MURLI KRISHNA PHARMA PVT LTDORLISTAT PELLETS 50.0% W/W
30781AII8/12/2016CENTAUR PHARMACEUTICALS PRIVATE LTDZOLPIDEM TARTRATE USP
30782AIII7/18/2016HEENA ROTO PRINTSALUMINIUM BLISTER FOIL (COATED/PRINTED)
30783AIV7/28/2016ABELEI INC188A10 NATURAL RASPBERRY TYPE FLAVOR
30784AIII8/6/2016JAYCOT INDUSTRIESPURIFIED COTTON (ABSORBENT COTTON) ROLLS AND COILS
30785AIII8/15/2016JAYCOT INDUSTRIESPURIFIED RAYON/RAYON COILS & POLYESTER COILS
30786AIII8/4/2016AMUL POLYMERSPLAIN & PLATINUM CURED SILICONE TUBING, BRAIDED HOSE, GASKETS, 'O' RINGS, SHEETS, SLEEVES ETC.
30787AII8/17/2016ALKEM LABORATORIES LTDESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
30788AII9/23/2016SUN PHARMACEUTICAL INDUSTRIES LTDAPIXABAN
30789AII7/27/2016HIKMA PHARMACEUTICALS PLCMETHYLPREDNISOLONE ACETATE USP (STERILE)
30790AII8/1/2016DIVI'S LABOTATORIES LTDPREGABALIN (ALTERNATIVE PROCESS)
30791AIII7/29/2016POLYONE CORPCC10233864XX
30792AIII7/28/2016TAIWAN FOREVER INDUSTRY CO LTDES-807 CHILD RESISTANT PACKAGING ALUMINUM FOIL
30793AII7/30/2016JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTDPROGESTERONE
30795AV8/31/2016CELGENE CORPLENALIDOMIDE REMS HOSTED SYSTEM
30799AII7/19/2016JIANGSU JOYGLORY PHARMACEUTICAL CO LTDAMBRISENTAN
30800AII7/28/2016HYBIO PHARMACEUTICAL CO LTDGANIRELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
30801AII8/17/2016AUROBINDO PHARMA LTDEZETIMIBE USP
30802AII8/8/2016ZHEJIANG AUSUN PHARMACEUTICAL CO LTDLUBIPROSTONE
30803A II10/5/2016RAKS PHARMA PVT LTDDARUNAVIR
30804A II11/2/2016RAKS PHARMA PVT LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE USP
30805AIII8/4/2016ARAB MEDICAL CONTAINERS CO LTD28MM HDPE PACKAGING SYSTEM
30806AII9/27/2016ENALTEC LABS PRIVATE LTDMIDODRINE HYDROCHLORIDE USP
30807AIII9/12/2016CORNING INCPHARMACEUTICAL GLASS CONTAINERS
30808AIII7/29/2016AMPACET CORP1602313-N TRANS BLUE SMC PE MB
30810AII8/30/2016APOTEX PHARMACHEM INDIA PVT LTDPERINDOPRIL ARGININE
30811AII8/13/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOPROTERENOL HYDROCHLORIDE
30812AIII8/1/2016INEOS STYROLUTION GROUP GMBHZYLAR« RESINS
30813AII9/19/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDETHACRYNATE SODIUM
30814AII8/20/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOMIPRAMINE HYDROCHLORIDE
30815AII8/2/2016ANTIBIOTICOS DE LEON SLUAMPICILLIN TRIHYDRATE
30816AIII9/26/2016SANOK RUBBER CO SARUBBER 'STOPPER' LK-6/1/E
30817AII9/20/2016CIPLA LTDDEFERASIROX
30818AIV8/5/2016FONA INTERNATIONAL INC819.0029U BUTTERSCOTCH TYPE FLAVOR NAT & ART
30819AIII7/11/2016RELIANCE INDUSTRIES LTDREPOL H110MAS
30820AII8/5/2016SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE ACETATE USP
30823AII9/26/2016TORRENT PHARMACEUTICALS LTDDIMETHYL FUMARATE
30824AII7/11/2016CALTRON CLAYS AND CHEMICALS PVT LTDCORAL CALCIUM CARBONATE
30825AII8/1/2016CHONGQING KANGLE PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE USP
30826AIV8/5/2016ABELEI INC231A12 NATURAL MASKING TYPE FLAVOR
30827AIV8/5/2016ABELEI INC231A39 NATURAL BITTERNESS MASKING TYPE FLAVOR
30828AIII8/4/2016BRAUNFORM GMBHCOMPONENTS FOR THE ESTRADIOL VAGINAL INSERT (APPLICATOR) DEVICE
30829AIII7/17/2016SHREE SHYAM PACKAGINGVMCH COATED & PRINTED ALUMINIUM FOILS
30831AII9/7/2016DSM NUTRITIONAL PRODUCTS LTDRIBOFLAVIN 5-PHOSPHATE SODIUM
30832AII9/20/2016DSM NUTRITIONAL PRODUCTS LTDCHOLECALCIFEROL (VITAMIN D3)
30833AII9/28/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDD-PENICILLAMINE
30834AII9/13/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDREGADENOSON
30835AII9/28/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDFERRIC CITRATE
30836AII7/18/2016STERLING BIOTECH LTDSIMVASTATIN AMMONIUM SALT DRUG SUBSTANCE INTERMEDIATE
30837AII7/20/2016STERLING BIOTECH LTDSIMVASTATIN USP
30838AIII8/3/2016ROLLPRINT PACKAGING PRODUCTS INCRPP#37-1249
30839AIII8/9/2016ROLLPRINT PACKAGING PRODUCTS INCRPP#36-1011G
30840AIV8/11/2016FONA INTERNATIONAL INC822.0418U N-C CARAMEL FLAVOR NAT & ART
30841AIV8/11/2016FONA INTERNATIONAL INC936.1204U FONATECH« TASTE MODIFIER FLAVOR NAT
30842AIV8/11/2016FONA INTERNATIONAL INC936.0504U BITTERNESS MASKING FLAVOR NAT
30843AIV8/9/2016FONA INTERNATIONAL INC805.0092U N-C BANANA TYPE FLAVOR NAT
30844AII8/2/2016LIFE TECHNOLOGIES LTDINCHINNAN AGT MEDIA
30845AII9/30/2016NATCO PHARMA LTDAPIXABAN
30847AIV8/16/2016GELCAPS INDUSTRIESEMPTY HARD GELATIN CAPSULES
30848AII8/18/2016ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE
30849AII9/13/2016APICORE US LLCSODIUM NITROPRUSSIDE USP
30850AII9/7/2016NEULAND LABORATORIES LTDMIRTAZAPINE USP (ACETONE ROUTE)
30851AIII7/27/2016APPLE CONVERTING INCAPPLE TDPS C086
30852AII9/9/2016CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE
30853AII8/19/2016CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDCANAGLIFLOZIN MONOHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)
30854AIII8/19/2016ENVASES COMERCIALES ENVASA SAINJECTION-BLOW MOLDING BOTTLES (IBM) AND CAPS
30855AIV8/18/2016FONA INTERNATIONAL INC926.2128U N-C COOL VANILLA TYPE FLAVOR NAT & ART
30856AIII8/17/2016INNOVAPLAST SA DE CVSTICKS PLASTICS BOTTLE
30857AII9/22/2016HONOUR LAB LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE
30858A II10/18/2016HONOUR LAB LTDOSPEMIFENE
30860AII9/5/2016QILU TIANHE PHARMACEUTICAL CO LTDTADALAFIL
30861AII9/27/2016ESJAY PHARMA LLCTREPROSTINIL SODIUM
30862AII9/12/2016ESJAY PHARMA LLCCHLORZOXAZONE USP
30863AII9/30/2016MICRO LABS LTDDIMETHYL FUMARATE
30866AII8/31/2016MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (FORM-M)
30867AIII8/27/2016PRINTMANN FOILSHSL COATED, LAMINATED & PRINTED ALUMINIUM FOILS
30868AII9/19/2016ALEMBIC PHARMACEUTICALS LTDGEFITINIB
30871AII9/30/2016CADILA HEALTHCARE LTDIMATINIB MESYLATE
30874AII8/31/2016HEC PHARM CO LTDAPIXABAN NON-STERILE BULK DRUG SUBSTANCE
30875AII9/2/2016MSN LIFE SCIENCES PRIVATE LTDCLOBAZAM
30877AII9/6/2016MSN LABORATORIES PRIVATE LTDPLERIXAFOR
30878A II11/9/2016ESJAY PHARMA LLCTRIENTINE HYDROCHLORIDE USP
30879AII9/20/2016ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCANAGLIFLOZIN
30880AII9/30/2016BIOCON LIMITEDMICAFUNGIN SODIUM
30882A II10/6/2016MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR (AMORPHOUS)
30884AII9/1/2016EVOLV LLCEVOLV E-LIQUID
30885AII8/29/2016INTAS PHARMACEUTICALS LTDERLOTINIB HYDROCHLORIDE
30886AII9/30/2016BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE III
30888AIII8/24/2016SAINT GOBAIN PERFORMANCE PLASTICSPET C/1/S WITH 7819 SILICONE RELEASE COATING
30889AII8/22/2016NEWGEN BIOTECH (NINGBO)LACTASE USP
30890A II10/11/2016ABBVIE STEMCENTRX LLCSC-LD003
30891AII9/21/2016MSN LIFE SCIENCES PRIVATE LTDLEVOMILNACIPRAN HYDROCHLORIDE
30892AII9/30/2016GLENMARK PHARMACEUTICALS LTDEFINACONAZOLE
30893AIII8/29/2016SAGAR RUBBER PRODUCTS PVT LTDBLOOD COLLECTION STOPPER
30894AII8/24/2016NOF CORP2,3-BIS(METHYLPOLYOXYETHYLENE-OXY)-1-{[3-(3-MALEIMIDO-1-OXOPROPYL)AMINO]PROPYLOXY} PROPANE (MW 60,000)
30895AIII8/10/2016AMPACET CORP103429 PERMSTAT 429 MB
30897AII8/29/2016ROQUETTE FRERESHYDROXYPROPYL BETADEX
30898AIII8/30/2016LINHARDT GMBH AND CO KGLAMINATED TUBES
30899AIII8/25/2016DOCTORPACK INDIA PVT LTDVETERINARY SYRINGE
30901AII9/15/2016ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDESOMEPRAZOLE MAGNESIUM
30903AIII7/21/2016MRK PACKAGINGALUMINIUM COLLAPSIBLE TUBES
30904A V10/25/2016WUXI APPTEC INCSTERILE PROCESSING FACILITY
30905AII9/15/2016NAVINTA LLCTRIENTINE HYDROCHLORIDE USP
30907AIII8/23/2016SHANDONG PHARMACEUTICAL GLASS CO LTDINJECTABLE GLASS CONTAINERS MADE OF BOROSILICATE GLASS TUBING
30908AIII8/25/2016AMPACET CORP4600965-NF FL PURPLE SMC PP MB
30909AIII8/30/2016DOCTORPACK INDIA PVT LTDVAGINAL APPLICATOR
30910AII9/20/2016NAVINTA LLCPHYTONADIONE USP (PROCESS A)
30911AII8/23/2016HEBEI WORLDSTAR CHEMICAL CO LTD4AA (4-ACETOXYAZETIDIN-2-ONE)
30912AII8/23/2016HEBEI WORLDSTAR CHEMICAL CO LTDMAP (BETA-METHYL VINYL PHOSPHATE)
30913AII9/30/2016HEC PHARM CO LTDALOGLIPTIN BENZOATE NON-STERILE BULK DRUG SUBSTANCE
30915AIV9/1/2016ABELEI INC160A04 NAT & ART JUICY LEMON FLAVOR
30916AIV9/1/2016ABELEI INC151A39 NATURAL HONEY FLAVOR WONF
30917AIII9/7/2016SINOPEC ASSETS MANAGEMENT CORP BALING PETROCHEMICAL BRANCHSTYRENE BLOCK POLYMERS WITH 1 3 BUTADIENE HYDROGENATED
30918AIV9/2/2016FONA INTERNATIONAL INC856.2124U GRAPE TYPE FLAVOR NAT & ART
30919AII8/25/2016NINGBO GREEN HEALTH PHARMACEUTICAL CO LTD10-DAB
30922AII9/30/2016GRANULES INDIA LTDPIRFENIDONE
30923AIII9/16/2016MANJUSHREE TECHNOPACK LTDPET & HDPE BOTTLES
30924AII9/28/2016LONZA AGEXENATIDE USP
30928AII9/15/2016AUROBINDO PHARMA LTDDIMETHYL FUMARATE
30929AII9/16/2016UNICHEM LABORATORIES LTDAPIXABAN
30930A II10/21/2016CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET-10258867]
30931AIV9/8/2016DAH FENG CAPSULE INDUSTRY CO LTDEMPTY HARD SHELL ACID RESISTANT VEGETABLE CAPSULES (HYDROXYPROPYL METHYL CELLULOSE
30934AII9/29/2016LAURUS LABS PRIVATE LTDATAZANAVIR SULFATE
30935AII9/28/2016LAURUS LABS PRIVATE LTDDOLUTEGRAVIR SODIUM
30936AII9/29/2016TEVA PHARMACEUTICAL INDUSTRIES LTDDIMETHYL FUMARATE
30937AIII9/7/2016LOPAREX LLCPOLYESTER ( PET ) LINER
30938AII9/27/2016GRANULES INDIA LTDDIMETHYL FUMARATE
30941AII9/16/2016ALKEM LABORATORIES LTDCANAGLIFLOZIN
30942AII9/30/2016AZICO BIOPHORE INDIA PVT LTDLIOTHYRONINE SODIUM
30944AII9/20/2016ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDIMETHYL FUMARATE (PROCESS II)
30945AIII9/2/2016AMPACET CORP4600998 N FL PURPLE SMC PP MB
30946AIII9/2/2016AMPACET CORP4300364 N YELLOW SMC PP MB
30948AII8/29/2016RIOCARE INDIA PRIVATE LTDSIMETHICONE USP
30949AII8/29/2016RIOCARE INDIA PRIVATE LTDSIMETHICONE EMULSION USP
30950AII8/29/2016RIOCARE INDIA PRIVATE LTDDIMETHICONE USP
30951A II10/21/2016INDOCO REMEDIES LTDCANAGLIFLOZIN
30952AII9/20/2016SHILPA MEDICARE LTDPIRFENIDONE
30953A II10/21/2016APICORE US LLCPOMALIDOMIDE
30954AII9/28/2016HEC PHARM CO LTDARIPIPRAZOLE NON-STERILE BULK DRUG SUBSTANCE
30955A II10/20/2016WOCKHARDT BIO AGPALONOSETRON HYDROCHLORIDE USP
30956AIII9/1/2016INEOS STYROLUTION GROUP GMBHSTYROLUX« 3G46
30959A II10/21/2016ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDEFAVIRENZ USP
30960AII9/21/2016HETERO LABS LTDIMATINIB MESYLATE (FORM-B)
30962AII9/10/2016VITAL LABORATORIES PVT LTDMETHSCOPOLAMINE BROMIDE
30963AIII9/8/2016ROLLPRINT PACKAGING PRODUCTS INCRPP# 36-1011B
30964AII9/28/2016AUROBINDO PHARMA LTDCANAGLIFLOZIN
30967A II11/9/2016CIPLA LTDALBENDAZOLE (B) USP
30969AII9/30/2016MYLAN LABORATORIES LTDMACITENTAN
30970AIV9/14/2016CELANESE EVA POLYMERSETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE« K2367.X01
30971AII9/12/2016YANGZHOU PHARMACEUTICAL CO LTDHYDROCORTISONE VALERATE USP
30974A II10/12/2016HARMAN FINOCHEM LTDSITAGLIPTIN PHOSPHATE USP
30975A II10/7/2016HETERO LABS LTDDACLATASVIR DIHYDROCHLORIDE
30976AIV9/20/2016CREST CELLULOSE PRIVATE LTDPREGELATINIZED MAIZE STARCH (GELMAC)
30984AII9/21/2016BIOLOGICAL INDUSTRIES ISRAEL BEIT-HAEMEK LTDNUTRISTEM« HPSC XF
30987A IV10/12/2016CAPSUGEL MANUFACTURING INCVCAPS? ENTERIC CAPSULES
30988AII8/9/2016YUNG ZIP CHEMICAL IND CO LTDMICONAZOLE BASE
30989AIII9/16/2016PLANET INDIA REMEDIES PVT LTDHDPE BOTTLES AND PP CLOSURES
30991A II11/9/2016CIPLA LTDTENOFOVIR ALAFENAMIDE FUMARATE
30992A II11/3/2016ALP PHARM BEIJING CO LTDOCTREOTIDE ACETATE
30993A II10/19/2016APICORE US LLCPENICILLAMINE, USP
30994AII9/30/2016ALKEM LABORATORIES LTDTOLTERODINE TARTRATE USP
30998AII9/21/2016JIANGSU WILLILNG BIO-TEC CO LTD IMIDACLOPRID NON STERILE BULK DRUG SUBSTANCE
31000A III10/4/2016JMT RUBBERPLAIN & BRAIDED SILICONE TUBINGS, SPONG & PROFILES
31001AV9/26/2016TRASIS SAALLINONE SYNTHESIZER
31002AII9/20/2016CKD BIO CORPVANCOMYCIN HYDROCHLORIDE
31004A II10/4/2016NATCO PHARMA LTDDIMETHYL FUMARATE
31006A III11/8/2016PRINTMANN FOILS DIV OF PRINTMANN OFFSET PRIVATE LTDHSL COATED AND PRINTED ALUMINIUM FOIL
31007A III10/6/2016PRINTMANN FOILSPOLY LAMINATED AND PRINTED ALUMINIUM FOILS
31008AIII9/23/2016POLYONE CORPCC10239784XX
31009AII9/30/2016MAITHRI DRUGS PRIVATE LTDZONISAMIDE USP
31011A II10/12/2016HETERO LABS LTDDARUNAVIR ETHANOLATE (PROCESS-II)
31012AIII9/23/2016POLYONE CORPCC01060914XX
31013AIV9/22/2016GELCAPS INDUSTRIESEMPTY HARD GELATIN CAPSULE SHELLS
31014AIII9/23/2016POLYONE CORPCC01060115XX
31015AIII9/23/2016POLYONE CORPCC01060732XX
31016AIII9/23/2016POLYONE CORPCC10236592XX
31017AIII9/23/2016POLYONE CORPCC01060593XX
31018AIII9/23/2016POLYONE CORPCC01060220XX
31019AIII9/23/2016POLYONE CORPCC01060729XX
31020AIII9/23/2016POLYONE CORPCC01060730XX
31021AIII9/23/2016POLYONE CORPCC01060604XX
31022AIII9/23/2016POLYONE CORPCC01059780XX
31023AII9/26/2016ADVANCED ACCELERATOR APPLICATIONS USA INCLYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTION
31025AII9/30/2016DR REDDYS LABORATORIES LTDCANAGLIFLOZIN
31028AII9/30/2016GLAND PHARMA LTDZIPRASIDONE MESILATE TRIHYDRATE
31033AII9/19/2016ZHEJIANG FENG'AN BIO-PHARMACEUTICAL CO LTDCHYMOTRYPSIN

Status:    P = Pending      A = Active      I = Inactive


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