Prestwick3_000009

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 31 USDMF, 22 CEP/COS, 8 JDMF, 10 EU WC, 17 KDMF, 18 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

3599 FDF Dossiers, 877 FDA Orange Book, 1902 Europe, 229 Canada, 2 Australia, 202 South Africa, 387 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG;25MG, TABLET;ORAL - 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL - 12.5MG;10MG, TABLET;ORAL - 12.5MG;20MG, TABLET;ORAL - 25MG;20MG, TABLET;ORAL - 12.5MG;100MG, TABLET;ORAL - 12.5MG;50MG, TABLET;ORAL - 25MG;100MG, CAPSULE;ORAL - 12.5MG, TABLET;ORAL - 12.5MG;150MG, TABLET;ORAL - 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL - 25MG;320MG, TABLET;ORAL - 16MG;12.5MG, TABLET;ORAL - 32MG;12.5MG, TABLET;ORAL - 32MG;25MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;80MG, TABLET;ORAL - 12.5MG;20MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 25MG;40MG, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 25 SPI Pharma, 2 Seqens, 17 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 14 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 4 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 39 BASF, 3 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 3 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 6 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 16 Seppic, 9 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 6 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

121 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 60 Direct Compression, 51 Disintegrants & Superdisintegrants, 41 Solubilizers, 40 Thickeners and Stabilizers, 40 Granulation, 38 Controlled & Modified Release, 38 Lubricants & Glidants, 36 Film Formers & Plasticizers, 33 Topical, 31 Parenteral, 28 Taste Masking, 23 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 14 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 145 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 1836 Finished Drug Prices, 16 Annual Reports

MARKET PLACE

30 APIs, 18 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 JP, 3 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21532 / DOSAGE - TABLET;ORAL - 12.5MG;20MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg \| 12.5mg \| 12.5mg
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	40mg \| 40mg \| 20mg

Inactive Ingredients

Ingredient Name	American Health Packaging	AvPAK	Bryant Ranch Prepack	Clinical Solutions Wholesale	IVAX Pharmaceuticals, Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	Unit Dose Services	A-S Medication Solutions	AvKARE, Inc.	Citron Pharma LLC	Eon Labs, Inc.	Hikma Pharmaceuticals USA Inc.	Lake Erie medical DBA Quality Care Products LLC	Legacy Pharmaceutical Packaging, LLC	NuCare Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	St Marys Medical Park Pharmacy	Apotex Corp.	Aphena Pharma Solutions - Tennessee, LLC	Golden State Medical Supply, Inc.	International Laboratories, LLC	AstraZeneca Pharmaceuticals LP	REMEDYREPACK INC.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Torrent Pharmaceuticals Limited	Mylan Pharmaceuticals Inc.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Direct_Rx	Quality Care Products, LLC	Accord Healthcare Inc.	Cardinal Health	DirectRX	NuCare Pharmaceuticals,Inc.	Solco Healthcare US, LLC	Sun Pharmaceutical Industries, Inc.	Teva Pharmaceuticals USA, Inc.	Alembic Pharmaceuticals Limited	Sun Pharmace
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(68401960MK)
D&C RED NO. 30(2S42T2808B)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (200000 MW)(5Y0974F5PW)
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(NZ94SDL6WR)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)(7773C1ROEU)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: Prestwick3_000009