CAFFEINE (ANHYDROUS) | 11483 | CAPSULE;ORAL | 356.4MG;30MG;16MG

CAFFEINE ANHYDROUS

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 10 USDMF, 9 CEP/COS, 11 JDMF, 1 KDMF, 18 NDC API, 24 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

369 FDF Dossiers, 126 FDA Orange Book, 15 Europe, 24 Canada, 129 South Africa, 75 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 356.4MG;30MG;16MG, TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 100MG;1MG, TABLET;ORAL - 325MG;50MG;40MG, SUPPOSITORY;RECTAL - 100MG;2MG, TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 14 Rochem International Inc, 30 SPI Pharma, 2 Seqens, 26 DKSH, 3 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 1 ICE Pharma, 16 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 21 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 46 BASF, 1 Bioplus Life Sciences, 4 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 15 Gangwal Chemicals, 1 Hayashibara, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 26 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 46 Roquette, 20 Seppic, 3 Shandong Focus Biotechnology Co., Ltd, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

128 Fillers, Diluents & Binders, 66 Coating Systems & Additives, 63 Thickeners and Stabilizers, 56 Topical, 55 Solubilizers, 54 Direct Compression, 46 Disintegrants & Superdisintegrants, 44 Taste Masking, 37 Controlled & Modified Release, 37 Parenteral, 37 Granulation, 31 Film Formers & Plasticizers, 28 Lubricants & Glidants, 25 Co-Processed Excipients, 24 Emulsifying Agents, 24 Chewable & Orodispersible Aids, 18 Surfactant & Foaming Agents, 14 API Stability Enhancers, 12 Rheology Modifiers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

32 NEWS #PharmaBuzz

32 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices

MARKET PLACE

78 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 2 JP, 5 Others

ANALYTICAL

1 BioAnalytical Methods, 13 Analytical Methods

$ Xls

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Xls

USFDA APPLICATION NUMBER - 11483 / DOSAGE - CAPSULE;ORAL - 356.4MG;30MG;16MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN(UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	356.4mg
CAFFEINE(UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	30mg
DIHYDROCODEINE BITARTRATE(UNII: 8LXS95BSA9) ( DIHYDROCODEINE - UNII:N9I9HDB855)	DIHYDROCODEINE BITARTRATE	16mg

Inactive Ingredients

Ingredient Name	Caraco Pharma Inc.	Caraco Pharmaceutical Laboratories, Ltd	WraSer LLC
ALGINIC ACID(8C3Z4148WZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE(68401960MK)
D&C RED NO. 28(767IP0Y5NH)
FD&C BLUE NO. 1(H3R47K3TBD)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
MAGNESIUM STEARATE(70097M6I30)
POVIDONE(FZ989GH94E)
POWDERED CELLULOSE(SMD1X3XO9M)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: CAFFEINE (ANHYDROUS)