Koffein [German]

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ACTIVE PHARMA INGREDIENTS

67 API Suppliers, 10 USDMF, 10 CEP/COS, 11 JDMF, 1 EU WC, 6 KDMF, 18 NDC API, 31 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

64 Drugs in Development

64 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

482 FDF Dossiers, 126 FDA Orange Book, 104 Europe, 30 Canada, 133 South Africa, 89 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356.4MG;30MG;16MG, TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL -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

2 EUROAPI, 1 Minakem, 1 Evonik, 13 Rochem International Inc, 31 SPI Pharma, 31 DKSH, 2 Pharm-RX Chemical, 9 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 1 ICE Pharma, 16 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 13 Kirsch Pharma, 4 ACG Worldwide, 21 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 46 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 4 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 3 Finar, 15 Gangwal Chemicals, 1 Hayashibara, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 26 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 11 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, 11 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

110 Fillers, Diluents & Binders, 75 Thickeners and Stabilizers, 61 Coating Systems & Additives, 61 Topical, 58 Solubilizers, 49 Disintegrants & Superdisintegrants, 49 Direct Compression, 46 Parenteral, 45 Taste Masking, 42 Granulation, 33 Controlled & Modified Release, 30 Film Formers & Plasticizers, 27 Lubricants & Glidants, 27 Emulsifying Agents, 26 Chewable & Orodispersible Aids, 20 Surfactant & Foaming Agents, 18 Rheology Modifiers, 18 Co-Processed Excipients, 12 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

33 News #PharmaBuzz

33 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 6 Regulatory FDF Prices

MARKET PLACE

89 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 JP, 15 Others

ANALYTICAL

1 BioAnalytical Methods, 13 Analytical Methods

$ Xls

Filters

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: Koffein [German]

Koffein [German]

Koffein [German]

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

67 API Suppliers

10 USDMF

10 CEP/COS

11 JDMF

1 EU WC

6 KDMF

18 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

482 FDF Dossiers

126 FDA Orange Book

104 Europe

30 Canada

133 South Africa

89 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

2 EUROAPI

1 Minakem

1 Evonik

13 Rochem International Inc

31 SPI Pharma

31 DKSH

2 Pharm-RX Chemical

9 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

1 ICE Pharma

16 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

13 Kirsch Pharma

4 ACG Worldwide

21 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

46 BASF

1 Bioplus Life Sciences

3 CD Formulation

4 Clariant

13 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

3 Finar

15 Gangwal Chemicals

1 Hayashibara

5 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

4 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

26 Microlex e.U

1 Nanjing Bold Chemical

2 Nippon Fine Chemical

TABLET;ORAL - 325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons