Raltegravir Potassium | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Raltegravir Potassium
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Raltegravir Potassium

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 9 USDMF, 2 CEP/COS, 5 EU WC, 4 KDMF, 8 NDC API, 21 Listed Suppliers, $ API Reference Price

28 API Suppliers
9 USDMF
2 CEP/COS
5 EU WC
4 KDMF
8 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

14 Intermediate 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, 18 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 8 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 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

69 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 26 Direct Compression, 26 Taste Masking, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 23 Disintegrants & Superdisintegrants, 20 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 18 Film Formers & Plasticizers, 17 Granulation, 14 Parenteral, 13 Co-Processed Excipients, 12 Solubilizers, 8 Topical, 7 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

10 NEWS #PharmaBuzz

10 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) : 729 Xls

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filter Applicant Reset all filters

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 6RX

filter Brand Name Reset all filters

7 All

01 1DUTREBIS

02 4ISENTRESS

03 1ISENTRESS HD

04 1RALTEGRAVIR POTASSIUM

filter RLD Reset all filters

7 All

01 2No

02 5Yes

List of Suppliers

Product Main Page

01

HETERO LABS LTD III

PharmScience R&D

Not Confirmed

HETERO LABS LTD III

PharmScience R&D

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

RALTEGRAVIR POTASSIUM

Brand Name : RALTEGRAVIR POTASSIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2024-12-19

Application Number : 203540

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Digital Content

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02

MERCK SHARP DOHME

PharmScience R&D

Not Confirmed

MERCK SHARP DOHME

PharmScience R&D

Not Confirmed

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Digital Content

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

PharmScience R&D

Not Confirmed

MSD SUB MERCK

PharmScience R&D

Not Confirmed

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RLD : Yes

TE Code : AB

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 : AB

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04

MSD SUB MERCK

PharmScience R&D

Not Confirmed

MSD SUB MERCK

PharmScience R&D

Not Confirmed

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Digital Content

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

PharmScience R&D

Not Confirmed

MSD SUB MERCK

PharmScience R&D

Not Confirmed

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Digital Content

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

PharmScience R&D

Not Confirmed

MSD SUB MERCK

PharmScience R&D

Not Confirmed

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Digital Content

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 :

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07

MSD SUB MERCK

PharmScience R&D

Not Confirmed

MSD SUB MERCK

PharmScience R&D

Not Confirmed

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Digital Content

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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