Prestalia

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

189 API Suppliers, 42 USDMF, 45 CEP/COS, 27 JDMF, 36 EU WC, 87 KDMF, 26 NDC API, 62 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1715 FDF Dossiers, 471 FDA Orange Book, 898 Europe, 135 Canada, 69 South Africa, 142 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, 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BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 22 SPI Pharma, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 5 Kirsch Pharma, 1 Panvo Organics, 10 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 35 BASF, 1 CD Formulation, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 3 Gloria Interchem, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 2 JJ Chemicals, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 49 Direct Compression, 46 Disintegrants & Superdisintegrants, 38 Thickeners and Stabilizers, 37 Granulation, 37 Solubilizers, 31 Lubricants & Glidants, 29 Controlled & Modified Release, 27 Topical, 25 Parenteral, 23 Chewable & Orodispersible Aids, 23 Film Formers & Plasticizers, 20 Taste Masking, 16 Co-Processed Excipients, 13 Emulsifying Agents, 11 API Stability Enhancers, 10 Surfactant & Foaming Agents, 9 Empty Capsules, 8 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

44 News #PharmaBuzz

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

49 US Medicaid Prescriptions, 36 Regulatory FDF Prices

MARKET PLACE

45 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

28 US Patents, 195 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 3 USP, 7 JP, 1 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20364 / DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;10MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE BESYLATE	2.5mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T) (BENAZEPRIL - UNII:UDM7Q7QWP8)	BENAZEPRIL HYDROCHLORIDE	10mg

Inactive Ingredients

Ingredient Name	Apotex Corp.	Bryant Ranch Prepack	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	A-S Medication Solutions	Actavis Pharma, Inc.	BluePoint Laboratories	Lupin Pharmaceuticals, Inc.	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	Cardinal Health	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	NCS HealthCare of KY, Inc dba Vangard Labs	Sandoz Inc	NuCare Pharmaceuticals, Inc.	Aidarex Pharmaceuticals LLC	American Health Packaging	Cipla USA Inc.	Dr.Reddy's Laboratories Limited	Par Pharmaceutical Inc.	Rebel Distributors Corp	REMEDYREPACK INC.
Ammonia(5138Q19F1X)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM PHOSPHATE(97Z1WI3NDX)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
Cellulose, microcrystalline(OP1R32D61U)
colloidal silicon dioxide(ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
D&C RED NO. 28(767IP0Y5NH)
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 GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE BLACK(XM0M87F357)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROGENATED CASTOR OIL(ZF94AP8MEY)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

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Disclaimers
Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Setid 48622cd3 1e25 4b08 B5bc F2552e436d1f Applno 20364 Form Capsule Oral Dosage Eq 5mg Base 10mg - Drug Product Composition: Prestalia

Prestalia

Prestalia

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

189 API Suppliers

42 USDMF

45 CEP/COS

27 JDMF

36 EU WC

87 KDMF

26 NDC API

62 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1715 FDF Dossiers

471 FDA Orange Book

898 Europe

135 Canada

69 South Africa

142 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE

TABLET;ORAL - EQ 5MG BASE

CAPSULE;ORAL - EQ 10MG BASE;20MG

CAPSULE;ORAL - EQ 10MG BASE;40MG

CAPSULE;ORAL - EQ 2.5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;20MG

CAPSULE;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;14MG

TABLET;ORAL - EQ 2.5MG BASE;3.5MG

TABLET;ORAL - EQ 5MG BASE;7MG

TABLET;ORAL - EQ 10MG BASE;200MG

TABLET;ORAL - EQ 2.5MG BASE;200MG

TABLET;ORAL - EQ 5MG BASE;200MG

TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 10MG BASE;160MG

TABLET;ORAL - EQ 10MG BASE;320MG

TABLET;ORAL - EQ 5MG BASE;160MG

TABLET;ORAL - EQ 5MG BASE;320MG

TABLET;ORAL - EQ 10MG BASE;20MG

TABLET;ORAL - EQ 10MG BASE;40MG

TABLET;ORAL - EQ 5MG BASE;20MG

TABLET;ORAL - EQ 5MG BASE;40MG

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 - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

3 Rochem International Inc

22 SPI Pharma

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

TABLET;ORAL - EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons