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List of Drug Master Files (DMF) of Acetaminophen Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Acetaminophen
CAS 121-71-1
4'-Hydroxyacetophenone
CAS 134-20-3
Aspirin
Caffeine
4-Nitrophenol
Acetanilide
CAS 556-08-1
Benorilate
USDMF

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Acetaminophen

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

117 API Suppliers, 80 USDMF, 22 CEP/COS, 16 JDMF, 7 EU WC, 108 KDMF, 107 NDC API, 30 Listed Suppliers, $ API Reference Price

117 API Suppliers
80 USDMF
22 CEP/COS
16 JDMF
7 EU WC
108 KDMF
107 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

FINISHED DOSAGE FORMULATIONS

2515 FDF Dossiers, 729 FDA Orange Book, 503 Europe, 290 Canada, 75 Australia, 402 South Africa, 516 Listed Dossiers

2515 FDF Dossiers
729 FDA Orange Book
503 Europe
290 Canada
75 Australia
402 South Africa
516 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

SUPPOSITORY;RECTAL - 120MG
SUPPOSITORY;RECTAL - 325MG
SUPPOSITORY;RECTAL - 650MG
SUPPOSITORY;RECTAL - 80MG
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 250MG;250MG;65MG
TABLET;ORAL - 325MG;37.5MG
SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 300MG;15MG
TABLET;ORAL - 300MG;30MG
TABLET;ORAL - 300MG;60MG
TABLET;ORAL - 325MG;5MG
TABLET;ORAL - 325MG;50MG;40MG
TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 1 Evonik, 14 Rochem International Inc, 31 SPI Pharma, 2 Seqens, 32 DKSH, 3 Jai Radhe Sales, 3 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 18 Gangwal Healthcare, 22 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 13 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 13 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

146 Fillers, Diluents & Binders, 81 Thickeners and Stabilizers, 71 Solubilizers, 69 Coating Systems & Additives, 62 Direct Compression, 60 Taste Masking, 54 Topical, 50 Disintegrants & Superdisintegrants, 46 Parenteral, 40 Granulation, 40 Controlled & Modified Release, 40 Lubricants & Glidants, 40 Film Formers & Plasticizers, 27 Chewable & Orodispersible Aids, 26 Emulsifying Agents, 24 Co-Processed Excipients, 18 Rheology Modifiers, 15 Surfactant & Foaming Agents, 13 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

146 Fillers, Diluents & Binders
81 Thickeners and Stabilizers
71 Solubilizers
69 Coating Systems & Additives
62 Direct Compression
60 Taste Masking
54 Topical
50 Disintegrants & Superdisintegrants
46 Parenteral
40 Granulation
40 Controlled & Modified Release
40 Lubricants & Glidants
40 Film Formers & Plasticizers
27 Chewable & Orodispersible Aids
26 Emulsifying Agents
24 Co-Processed Excipients
18 Rheology Modifiers
15 Surfactant & Foaming Agents
13 API Stability Enhancers
9 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

12 DATA COMPILATION #PharmaFlow, 339 NEWS #PharmaBuzz

12 DATA COMPILATION #PharmaFlow
339 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 406 Finished Drug Prices, 1 Annual Reports

7 US Medicaid Prescriptions
406 Finished Drug Prices
1 Annual Reports

MARKET PLACE

173 APIs, 95 FDF Dossiers

173 APIs
95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 3 Health Canada Patents

41 US Patents
2 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 7 USP, 1 JP, 26 Others

1 EDQM
7 USP
1 JP
26 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

2 BioAnalytical Methods
8 Analytical Methods

$ API Ref.Price (USD/KG) : 7 Xls

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80 All

01 4Granules India Limited

02 1IOL Chemicals and Pharmaceuticals

03 3Sanofi

04 1Seqens

05 8ANQIU LUAN PHARMACEUTICAL Co

06 1Abbott Laboratories

07 1Adare Pharma Solutions

08 1Anhui BBCA Likang pharmaceutical

09 1Atabay

10 1Aurobindo Pharma Limited

11 1Avantor Performance Materials

12 1BASF

13 1Bayer AG

14 1Beiersdorf AG

15 1Dinesh Pharmaceuticals

16 1Eli Lilly

17 3Farmson Pharmaceutical Gujarat Pvt Ltd

18 3HARTINGTON PHARMACEUTICAL

19 4Hebei Jiheng Pharmaceutical Co Ltd

20 1Industrias Monfel

21 1Jinzhou Jiutai Pharmaceutical

22 11Mallinckrodt Pharmaceuticals

23 2Meghmani Group

24 1Rhodia Organique SAS

25 3Sri Krishna Pharmaceuticals

26 1Yamamoto Corporation

27 3Zhejiang Kangle Pharmaceutical

28 1Zhejiang Ruibang Laboratories

29 18Blank

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80 All

01 1ACETAMINOFEN

02 14ACETAMINOPHEN

03 1ACETAMINOPHEN (BULK)

04 1ACETAMINOPHEN (PARACETAMOL)

05 1ACETAMINOPHEN 90%

06 1ACETAMINOPHEN CAPSULES

07 1ACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG.

08 1ACETAMINOPHEN D.C. 90 PVP

09 1ACETAMINOPHEN D.C. PVP

10 1ACETAMINOPHEN DC 90 3

11 1ACETAMINOPHEN DC 90 6

12 1ACETAMINOPHEN DC 90%

13 1ACETAMINOPHEN DC 90-3 SD

14 1ACETAMINOPHEN DC 90-9

15 1ACETAMINOPHEN DC GRANULAR

16 1ACETAMINOPHEN DC-PGS

17 1ACETAMINOPHEN DC90

18 1ACETAMINOPHEN DC90 FINE

19 1ACETAMINOPHEN DC90-10 SD

20 1ACETAMINOPHEN DC90-7SD

21 1ACETAMINOPHEN GRANULES DC 90%

22 1ACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F)

23 12ACETAMINOPHEN USP

24 1ACETAMINOPHEN USP (PARACETAMOL USP)

25 1ACETAMINOPHEN USP XX

26 1ACETAMINOPHEN, BULK FORM

27 1ACETAMINOPHEN, OTC

28 1ACETAMINOPHEN, USP

29 1ACETAMINOPHEN,73% GRANULATION

30 1APAP MICROCAPS