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Information, Expiry, & Status of FDA Orange Book Exclusivities covering 0431, MK

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0431, MK
U.S. EXCLUSIVITIES

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Granules Sitagliptin Phosphate

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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0431, MK

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

151 API Suppliers, 64 USDMF, 24 CEP/COS, 6 JDMF, 21 EU WC, 6 KDMF, 40 NDC API, 93 Listed Suppliers, $ API Reference Price

151 API Suppliers
64 USDMF
24 CEP/COS
6 JDMF
21 EU WC
6 KDMF
40 NDC API
93 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 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

52 API Suppliers

52 API Suppliers

FINISHED DOSAGE FORMULATIONS

549 FDF Dossiers, 65 FDA Orange Book, 231 Europe, 80 Australia, 11 South Africa, 162 Listed Dossiers

549 FDF Dossiers
65 FDA Orange Book
231 Europe
80 Australia
11 South Africa
162 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - 1GM;EQ 50MG BASE, TABLET;ORAL - 500MG;EQ 50MG BASE

TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - 1GM;EQ 50MG BASE
TABLET;ORAL - 500MG;EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 Minakem, 2 SPI Pharma, 2 Seqens, 11 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Coating Systems & Additives, 37 Fillers, Diluents & Binders, 30 Controlled & Modified Release, 23 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 18 Direct Compression, 17 Thickeners and Stabilizers, 13 Granulation, 11 Topical, 10 Co-Processed Excipients, 8 API Stability Enhancers, 8 Film Formers & Plasticizers, 7 Solubilizers, 6 Taste Masking, 5 Coloring Agents, 5 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 4 Parenteral, 3 Rheology Modifiers, 1 Surfactant & Foaming Agents

52 Coating Systems & Additives
37 Fillers, Diluents & Binders
30 Controlled & Modified Release
23 Lubricants & Glidants
19 Disintegrants & Superdisintegrants
18 Direct Compression
17 Thickeners and Stabilizers
13 Granulation
11 Topical
10 Co-Processed Excipients
8 API Stability Enhancers
8 Film Formers & Plasticizers
7 Solubilizers
6 Taste Masking
5 Coloring Agents
5 Chewable & Orodispersible Aids
5 Empty Capsules
4 Vegetarian Capsules
4 Emulsifying Agents
4 Parenteral
3 Rheology Modifiers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

15 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 130 NEWS #PharmaBuzz

15 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
130 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 200 Finished Drug Prices, 17 Annual Reports

2 US Medicaid Prescriptions
200 Finished Drug Prices
17 Annual Reports

MARKET PLACE

41 APIs, 20 FDF Dossiers

41 APIs
20 FDF Dossiers

PATENTS & EXCLUSIVITIES

45 US Patents, 16 US Exclusivities, 9 Health Canada Patents

45 US Patents
16 US Exclusivities
9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 9 Others

2 USP
9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 666 Xls

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01 6MERCK SHARP DOHME

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01 2ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

02 8METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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01 72023-12-04

02 72024-06-04

03 22024-09-17

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01 7M-187

02 2M-275

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drl Sitagliptin Phosphate

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M-187

Exclusivity Expiration Date

2023-12-04

Application Number

22044

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2

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2024-06-04

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21995

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Exclusivity Code

M-187

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Application Number

21995

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3

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Exclusivity Code : M-187

Exclusivity Expiration Date : 2023-12-04

Application Number : 21995

Product Number : 3

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21995

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209805

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Exclusivity Code : M-275

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M-187

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Application Number

21995

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Exclusivity Code : M-187

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Application Number

202270

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Exclusivity Code : M-187

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