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Approved Drug Products containing 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one listed in the FDA Orange Book. Original Data : FDA Website

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Product

2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one
FDA Orange Book

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

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Bora Pharmaceuticals- Making success more certain.

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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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PharmaCompass Sponsored Ads

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 7 USDMF, 2 CEP/COS, 1 JDMF, 2 EU WC, 4 NDC API, 16 Listed Suppliers, $ API Reference Price

21 API Suppliers
7 USDMF
2 CEP/COS
1 JDMF
2 EU WC
4 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

8 API Suppliers

8 API Suppliers

FINISHED DOSAGE FORMULATIONS

39 FDF Dossiers, 7 FDA Orange Book, 12 Europe, 1 Canada, 6 Australia, 2 South Africa, 11 Listed Dossiers

39 FDF Dossiers
7 FDA Orange Book
12 Europe
1 Canada
6 Australia
2 South Africa
11 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 7 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 3 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 10 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 13 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Fillers, Diluents & Binders, 27 Direct Compression, 16 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 15 Granulation, 12 Co-Processed Excipients, 11 Chewable & Orodispersible Aids, 11 Parenteral, 11 Taste Masking, 10 Lubricants & Glidants, 10 Coating Systems & Additives, 10 Solubilizers, 8 Controlled & Modified Release, 8 Empty Capsules, 4 Film Formers & Plasticizers, 3 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 1 API Stability Enhancers

50 Fillers, Diluents & Binders
27 Direct Compression
16 Thickeners and Stabilizers
16 Disintegrants & Superdisintegrants
15 Granulation
12 Co-Processed Excipients
11 Chewable & Orodispersible Aids
11 Parenteral
11 Taste Masking
10 Lubricants & Glidants
10 Coating Systems & Additives
10 Solubilizers
8 Controlled & Modified Release
8 Empty Capsules
4 Film Formers & Plasticizers
3 Coloring Agents
2 Rheology Modifiers
2 Emulsifying Agents
1 API Stability Enhancers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices, 3 Annual Reports

1 US Medicaid Prescriptions
6 Finished Drug Prices
3 Annual Reports

MARKET PLACE

8 APIs, 3 FDF Dossiers

8 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 4 Others

2 EDQM
3 USP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,817 Xls

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7 All

01 2BAUSCH AND LOMB

02 1EXELA PHARMA

03 2RANBAXY LABS LTD

04 2ROCHE PALO

filter Dosage Reset all filters

7 All

01 4CAPSULE;ORAL

02 1GEL;OPHTHALMIC

03 1IMPLANT;IMPLANTATION

04 1SOLUTION;INTRAVENOUS

filter Regulatory Info Reset all filters

7 All

01 5DISCN

02 2RX

filter Brand Name Reset all filters

7 All

01 2CYTOVENE

02 2GANCICLOVIR

03 1GANZYK-RTU

04 1VITRASERT

05 1ZIRGAN

filter RLD Reset all filters

7 All

01 3No

02 4Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

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01

BAUSCH AND LOMB

World Dairy Expo 2024

Not Confirmed

BAUSCH AND LOMB

World Dairy Expo 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

GANCICLOVIR

Brand Name : VITRASERT

Dosage Form : IMPLANT;IMPLANTATION

Dosage Strength : 4.5MG

Approval Date : 1996-03-04

Application Number : 20569

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

BAUSCH AND LOMB

World Dairy Expo 2024

Not Confirmed

BAUSCH AND LOMB

World Dairy Expo 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

GANCICLOVIR

Brand Name : ZIRGAN

Dosage Form : GEL;OPHTHALMIC

Dosage Strength : 0.15%

Approval Date : 2009-09-15

Application Number : 22211

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

EXELA PHARMA

World Dairy Expo 2024

Not Confirmed

EXELA PHARMA

World Dairy Expo 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

GANCICLOVIR

Brand Name : GANZYK-RTU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 500MG/250ML (2MG/ML)

Approval Date : 2017-02-17

Application Number : 209347

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ROCHE PALO

World Dairy Expo 2024

Not Confirmed

ROCHE PALO

World Dairy Expo 2024

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

GANCICLOVIR

Brand Name : CYTOVENE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-12-22

Application Number : 20460

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ROCHE PALO

World Dairy Expo 2024

Not Confirmed

ROCHE PALO

World Dairy Expo 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

GANCICLOVIR

Brand Name : CYTOVENE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-12-12

Application Number : 20460

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

RANBAXY LABS LTD

World Dairy Expo 2024

Not Confirmed

RANBAXY LABS LTD

World Dairy Expo 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

GANCICLOVIR

Brand Name : GANCICLOVIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2003-06-27

Application Number : 76457

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

RANBAXY LABS LTD

World Dairy Expo 2024

Not Confirmed

RANBAXY LABS LTD

World Dairy Expo 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code :

GANCICLOVIR

Brand Name : GANCICLOVIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2003-06-27

Application Number : 76457

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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