METHYLDOPA AND HYDROCHLOROTHIAZIDE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 31 USDMF, 24 CEP/COS, 7 JDMF, 10 EU WC, 17 KDMF, 19 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

3607 FDF Dossiers, 878 FDA Orange Book, 1902 Europe, 229 Canada, 2 Australia, 202 South Africa, 394 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- 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL -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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL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EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for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, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 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, 11 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, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 6 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

119 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 59 Direct Compression, 50 Disintegrants & Superdisintegrants, 40 Granulation, 40 Solubilizers, 40 Thickeners and Stabilizers, 38 Controlled & Modified Release, 38 Lubricants & Glidants, 36 Film Formers & Plasticizers, 33 Topical, 31 Parenteral, 28 Taste Masking, 24 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, 1837 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 - 20387 / DOSAGE - TABLET;ORAL - 25MG;100MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg
LOSARTAN POTASSIUM(UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)	LOSARTAN POTASSIUM	100mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	AvKARE, Inc.	Bryant Ranch Prepack	Medsource Pharmaceuticals	Merck Sharp & Dohme Corp.	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.	Watson Laboratories, Inc.	A-S Medication Solutions	Alembic Pharmaceuticals Inc.	AvPAK	Lake Erie Medical DBA Quality Care Products LLC	NorthStar RxLLC	Preferred Pharmaceuticals, Inc.	Sun Pharmaceutical Industries, Inc.	Torrent Pharmaceuticals Limited	Trigen Laboratories, LLC	Unit Dose Services	West-Ward Pharmaceuticals Corp.	GC Hanford Manufacturing Company	Apotex Corp.	Sandoz Inc.	ACETRIS HEALTH, LLC	American Health Packaging	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	Physicians Total Care, Inc.	Qualitest Pharmaceuticals	St Marys Medical Park Pharmacy	St. Marys Medical Park Pharmacy	Sandoz Inc	Direct Rx	McKesson Corporation dba SKY Packaging	NorthStar Rx LLC	Preferred Pharmaceuticals Inc.	Rising Health, LLC	Solco Healthcare US, LLC	ST. MARY'S MEDICAL PARK PHARMACY	Granules Pharmaceuticals Inc.
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6 (H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
hypromellose(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3000(SA1B764746)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLPARABEN(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: METHYLDOPA AND HYDROCHLOROTHIAZIDE