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Approved Drug Products containing Raltegravir listed in the FDA Orange Book. Original Data : FDA Website

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Product

Raltegravir
CAS 518048-03-8
FDA Orange Book

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

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xyz-pharma-m-2024-09-09

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Raltegravir

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 10 USDMF, 1 CEP/COS, 5 EU WC, 4 KDMF, 7 NDC API, 21 Listed Suppliers, $ API Reference Price

27 API Suppliers
10 USDMF
1 CEP/COS
5 EU WC
4 KDMF
7 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

17 API Suppliers

17 API Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 7 FDA Orange Book, 13 Europe, 3 Canada, 2 Australia, 3 South Africa, 1 Listed Dossiers

29 FDF Dossiers
7 FDA Orange Book
13 Europe
3 Canada
2 Australia
3 South Africa
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 600MG BASE

TABLET;ORAL - EQ 400MG BASE
TABLET;ORAL - EQ 600MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 7 Rochem International Inc, 17 SPI Pharma, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 6 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 33 Direct Compression, 26 Controlled & Modified Release, 25 Taste Masking, 25 Thickeners and Stabilizers, 20 Lubricants & Glidants, 20 Disintegrants & Superdisintegrants, 19 Chewable & Orodispersible Aids, 18 Film Formers & Plasticizers, 17 Granulation, 14 Parenteral, 14 Co-Processed Excipients, 11 Solubilizers, 8 Topical, 7 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

72 Fillers, Diluents & Binders
56 Coating Systems & Additives
33 Direct Compression
26 Controlled & Modified Release
25 Taste Masking
25 Thickeners and Stabilizers
20 Lubricants & Glidants
20 Disintegrants & Superdisintegrants
19 Chewable & Orodispersible Aids
18 Film Formers & Plasticizers
17 Granulation
14 Parenteral
14 Co-Processed Excipients
11 Solubilizers
8 Topical
7 Rheology Modifiers
5 Coloring Agents
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
3 Emulsifying Agents
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 9 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 9 Finished Drug Prices, 10 Annual Reports

1 US Medicaid Prescriptions
9 Finished Drug Prices
10 Annual Reports

MARKET PLACE

2 APIs, 5 FDF Dossiers

2 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

25 US Patents, 9 Health Canada Patents

25 US Patents
9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

$ API Ref.Price (USD/KG) : 764 Xls

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7 All

01 1HETERO LABS LTD III

02 1MERCK SHARP DOHME

03 5MSD SUB MERCK

filter Dosage Reset all filters

7 All

01 1POWDER;ORAL

02 2TABLET, CHEWABLE;ORAL

03 4TABLET;ORAL

filter Regulatory Info Reset all filters

7 All

01 1DISCN

02 5RX

03 1Blank

filter Brand Name Reset all filters

7 All

01 1DUTREBIS

02 4ISENTRESS

03 1ISENTRESS HD

04 1RALTEGRAVIR

filter RLD Reset all filters

7 All

01 1No

02 5Yes

03 1Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
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Product Main Page

01

HETERO LABS LTD III

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Digital Content

RLD :

TE Code :

RALTEGRAVIR

Brand Name : RALTEGRAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 203540

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

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02

MERCK SHARP DOHME

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RLD : No

TE Code :

LAMIVUDINE; RALTEGRAVIR POTASSIUM

Brand Name : DUTREBIS

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG;EQ 300MG BASE

Approval Date : 2015-02-06

Application Number : 206510

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

MSD SUB MERCK

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RLD : Yes

TE Code :

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2007-10-12

Application Number : 22145

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

MSD SUB MERCK

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RLD : Yes

TE Code :

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS HD

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE

Approval Date : 2017-05-26

Application Number : 22145

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

MSD SUB MERCK

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RLD : Yes

TE Code :

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2011-12-21

Application Number : 203045

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

MSD SUB MERCK

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RLD : Yes

TE Code :

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2011-12-21

Application Number : 203045

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

MSD SUB MERCK

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MSD SUB MERCK

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RLD : Yes

TE Code :

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : POWDER;ORAL

Dosage Strength : EQ 100MG BASE/PACKET

Approval Date : 2013-12-20

Application Number : 205786

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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