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- 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG,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 - 21392 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diltiazem Hydrochloride(UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)	Diltiazem Hydrochloride	420mg \| 360mg \| 300mg \| 240mg \| 180mg \| 120mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	REMEDYREPACK INC.	AbbVie Inc.	Cipla USA, Inc.
CANDELILLA WAX(WL0328HX19)
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)(P2OM2Q86BI)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
microcrystalline wax(XOF597Q3KY)
NONOXYNOL-100(A906T4D368)
polydextrose(VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
polysorbate 80(6OZP39ZG8H)
POVIDONE K30(U725QWY32X)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
sucrose stearate(274KW0O50M)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Diltiazem Hydrochloride