Diltiazem Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 8 CEP/COS, 5 JDMF, 4 EU WC, 6 KDMF, 17 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

338 FDF Dossiers, 214 FDA Orange Book, 18 Europe, 78 Canada, 7 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG, TABLET;ORAL - 30MG, TABLET;ORAL - 60MG, TABLET;ORAL - 90MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 420MG, TABLET, EXTENDED RELEASE;ORAL - 120MG, TABLET, EXTENDED RELEASE;ORAL - 180MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 360MG, TABLET, EXTENDED RELEASE;ORAL - 420MG

RELATED EXCIPIENT COMPANIES

5 Evonik, 4 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 22 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 9 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 33 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

103 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 58 Controlled & Modified Release, 44 Direct Compression, 38 Thickeners and Stabilizers, 37 Solubilizers, 30 Granulation, 30 Taste Masking, 28 Film Formers & Plasticizers, 22 Parenteral, 22 Lubricants & Glidants, 22 Disintegrants & Superdisintegrants, 21 Co-Processed Excipients, 17 Chewable & Orodispersible Aids, 16 Topical, 11 Emulsifying Agents, 9 Empty Capsules, 7 Rheology Modifiers, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

30 NEWS #PharmaBuzz

30 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 63 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

13 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

25 Health Canada Patents

25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 2 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 20401 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 420MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	180mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Avera McKennan Hospital	Bryant Ranch Prepack	NuCare Pharmaceuticals, Inc.	REMEDYREPACK INC.	Actavis Elizabeth LLC	Sandoz Inc
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C RED NO. 28(767IP0Y5NH)
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)(P2OM2Q86BI)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 40(WZB9127XOA)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
magnesium stearate(70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE STEARATE(274KW0O50M)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Diltiazem Hydrochloride