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Information, Expiry, & Status of FDA Orange Book Exclusivities covering Tox21_202458

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Tox21_202458
U.S. EXCLUSIVITIES

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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FAMAR CDMO- From early development to commercial manufacturing.

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xyz-pharma-m-2024-09-09

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Veranova: A CDMO that manages complexity with confidence.

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xyz-pharma-m-2024-09-09

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Tox21_202458

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 8 NDC API, 13 Listed Suppliers, $ API Reference Price

17 API Suppliers
7 USDMF
4 CEP/COS
2 JDMF
3 EU WC
8 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 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

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

355 FDF Dossiers, 125 FDA Orange Book, 129 Europe, 15 Canada, 31 Australia, 18 South Africa, 37 Listed Dossiers

355 FDF Dossiers
125 FDA Orange Book
129 Europe
15 Canada
31 Australia
18 South Africa
37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG, GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 2.5MG/0.5ML (5MG/ML), GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 2MG
TABLET;ORAL - 5MG
GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 2.5MG/0.5ML (5MG/ML)
GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 1 DKSH, 1 Jai Radhe Sales, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 30 Direct Compression, 28 Disintegrants & Superdisintegrants, 26 Controlled & Modified Release, 20 Thickeners and Stabilizers, 19 Lubricants & Glidants, 19 Granulation, 18 Film Formers & Plasticizers, 16 Topical, 15 Co-Processed Excipients, 13 Taste Masking, 9 Solubilizers, 9 Parenteral, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

65 Fillers, Diluents & Binders
47 Coating Systems & Additives
30 Direct Compression
28 Disintegrants & Superdisintegrants
26 Controlled & Modified Release
20 Thickeners and Stabilizers
19 Lubricants & Glidants
19 Granulation
18 Film Formers & Plasticizers
16 Topical
15 Co-Processed Excipients
13 Taste Masking
9 Solubilizers
9 Parenteral
8 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 Empty Capsules
4 Rheology Modifiers
4 Vegetarian Capsules
4 API Stability Enhancers
2 Coloring Agents
2 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 68 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
68 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 136 Finished Drug Prices, 3 Annual Reports

4 US Medicaid Prescriptions
136 Finished Drug Prices
3 Annual Reports

MARKET PLACE

29 APIs, 24 FDF Dossiers

29 APIs
24 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 8 US Exclusivities, 1 Health Canada Patents

23 US Patents
8 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 10 Others

2 EDQM
2 USP
10 Others

$ API Ref.Price (USD/KG) : 223 Xls

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