Prestwick3_000493

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

110 API Suppliers, 43 USDMF, 36 CEP/COS, 10 JDMF, 26 EU WC, 25 KDMF, 33 NDC API, 2 VMF, 69 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

23 API Suppliers

23 API Suppliers

FINISHED DOSAGE FORMULATIONS

924 FDF Dossiers, 95 FDA Orange Book, 571 Europe, 11 Canada, 53 Australia, 40 South Africa, 154 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE;ORAL - 40MG;1.1GM, TABLET, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 13 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 40 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 4 Finar, 13 Gangwal Chemicals, 14 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 52 Direct Compression, 48 Controlled & Modified Release, 45 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 38 Solubilizers, 36 Granulation, 30 Taste Masking, 29 Lubricants & Glidants, 27 Topical, 22 Chewable & Orodispersible Aids, 22 Parenteral, 22 Film Formers & Plasticizers, 22 Co-Processed Excipients, 10 Emulsifying Agents, 9 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 81 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 523 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

59 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

14 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 50 Others

ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 22281 / DOSAGE - CAPSULE;ORAL - 20MG;1.1GM

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OMEPRAZOLE(UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1100mg

Inactive Ingredients

Ingredient Name	Akron Pharma Inc	AvKARE, Inc.	Cipla USA Inc.	Medarbor Llc	Par Pharmaceutical Inc.	Dr.Reddy's Laboratories Limited	Bayer HealthCare LLC	Guardian Drug Company	Northstar Rx LLC	Oceanside Pharmaceuticals	Prasco Laboratories	HyVee Inc	Topco Associates LLC
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
ISOPROPYL ALCOHOL(ND2M416302)
MAGNESIUM STEARATE(70097M6I30)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SHELLAC(MB5IUD6JUA)
silicon dioxide(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
SODIUM(9NEZ333N27)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Prestwick3_000493