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- 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL -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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL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EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for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 - 21162 / DOSAGE - TABLET;ORAL - 12.5MG;40MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5mg \| 25mg
TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80mg \| 80mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Macleods Pharmaceuticals Limited	Mylan Pharmaceuticals Inc.	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.	Torrent Pharmaceuticals Limited	Lupin Pharmaceuticals, Inc.	Glenmark Pharmaceuticals Inc., USA	Solco Healthcare LLC	Bryant Ranch Prepack	Zydus Pharmaceuticals USA Inc.	Accord Healthcare Inc.	Alembic Pharmaceuticals Inc.	Cardinal Health	DirectRX	NuCare Pharmaceuticals,Inc.	Qualitest Pharmaceuticals	Solco Healthcare US, LLC	Sun Pharmaceutical Industries, Inc.	Teva Pharmaceuticals USA, Inc.	Alembic Pharmaceuticals Limited
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C RED NO. 30(2S42T2808B)
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 OXIDE(3A3U0GI71G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MEGLUMINE(6HG8UB2MUY)
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 K25(K0KQV10C35)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: METHYLDOPA AND HYDROCHLOROTHIAZIDE