DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 6 USDMF, 2 CEP/COS, 1 JDMF, 2 EU WC, 4 NDC API, 15 Listed Suppliers, $ API Reference Price

19 API Suppliers
6 USDMF
2 CEP/COS
1 JDMF
2 EU WC
4 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

8 Intermediates 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, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 4 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, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 26 Direct Compression, 16 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 15 Granulation, 13 Co-Processed Excipients, 11 Chewable & Orodispersible Aids, 11 Parenteral, 11 Taste Masking, 10 Lubricants & Glidants, 10 Coating Systems & Additives, 9 Solubilizers, 8 Empty Capsules, 8 Controlled & Modified Release, 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

media
2 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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

MARKET PLACE

8 APIs, 3 FDF Dossiers

marketPlace
8 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

patents
1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 3 USP , 4 Others

otherSolutions
2 EDQM
3 USP
4 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,787

MARKET PLACE

API

FDF

8INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

8,818,227

Annual Reports (USD Million)

557

Finished Drug Prices

132 RELATED EXCIPIENT COMPANIES

223EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as:

Molecular Formula

C₉H₁₃N₅O₄

Molecular Weight

255.23 g/mol

InChI Key

IRSCQMHQWWYFCW-UHFFFAOYSA-N

1 2D Structure

Ganciclovir

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

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

2.1.2 InChI

InChI=1S/C9H13N5O4/c10-9-12-7-6(8(17)13-9)11-3-14(7)4-18-5(1-15)2-16/h3,5,15-16H,1-2,4H2,(H3,10,12,13,17)

2.1.3 InChI Key

IRSCQMHQWWYFCW-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=NC2=C(N1COC(CO)CO)NC(=NC2=O)N

2.1.5 Isomeric SMILES

C1=NC2=C(N1COC(CO)CO)NC(=NC2=O)N

2.2 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₃N₅O₄
Molecular Weight	255.23 g/mol
XLogP3	-1.7
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	5
Exact Mass	255.09675391 g/mol
Monoisotopic Mass	255.09675391 g/mol
Topological Polar Surface Area	135 A^2
Heavy Atom Count	18
Formal Charge	0
Complexity	346
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Cytovene
PubMed Health	Ganciclovir (Injection)
Drug Classes	Antiviral
Drug Label	Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno...
Active Ingredient	Ganciclovir sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial
Market Status	Prescription
Company	Roche Palo

2 of 6
Drug Name	Ganciclovir
PubMed Health	Ganciclovir
Drug Classes	Antiviral
Drug Label	Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s...
Active Ingredient	Ganciclovir sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial
Market Status	Prescription
Company	Fresenius Kabi Usa; Luitpold

3 of 6
Drug Name	Zirgan
PubMed Health	Ganciclovir
Drug Classes	Antiviral
Drug Label	ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu...
Active Ingredient	Ganciclovir
Dosage Form	Gel
Route	Ophthalmic
Strength	0.15%
Market Status	Prescription
Company	Bausch And Lomb

4 of 6
Drug Name	Cytovene
PubMed Health	Ganciclovir (Injection)
Drug Classes	Antiviral
Drug Label	Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno...
Active Ingredient	Ganciclovir sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial
Market Status	Prescription
Company	Roche Palo

5 of 6
Drug Name	Ganciclovir
PubMed Health	Ganciclovir
Drug Classes	Antiviral
Drug Label	Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s...
Active Ingredient	Ganciclovir sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 500mg base/vial
Market Status	Prescription
Company	Fresenius Kabi Usa; Luitpold

6 of 6
Drug Name	Zirgan
PubMed Health	Ganciclovir
Drug Classes	Antiviral
Drug Label	ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu...
Active Ingredient	Ganciclovir
Dosage Form	Gel
Route	Ophthalmic
Strength	0.15%
Market Status	Prescription
Company	Bausch And Lomb

API SUPPLIERS

01

Hubei Gedian Humanwell Pharmaceuti...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

China

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Fareva

Luxembourg

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

Luxembourg

Virtual Booth

Digital Content

USDMF

CEP/COS

JDMF

EU-WC NDC KDMF VMF Others AUDIT

03

CHANGZHOU KONY PHARMACEUTICAL CO.,...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

04

Aurobindo Pharma Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

05

Trifarma

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

06

RANBAXY LABORATORIES LIMITED

India

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Excella Gmbh And Co Kg

Luxembourg

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

Luxembourg

Virtual Booth

Digital Content

Ganciclovir

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-30

Pay. Date : 2013-01-08

DMF Number : 15567

Submission : 2001-07-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Italy

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

CEP/COS

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JDMF

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"322.00","actualQuantity":"322","unit":"KGS","unitRateFc":"1400","totalValueFC":"455501.2","currency":"USD","unitRateINR":"118090","date":"04-Jun-2024","totalValueINR":"38024980","totalValueInUsd":"455501.2","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"3812844","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM 6\/7 20090 RODANO MI IT Rodano, , ItalySDNF Italy","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718389800,"product":"(FOC) - GANCICLOVIR USP GEL 0.15 % - P0049-71-04","address":"REGD. 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QUANZHOU FORTUNE BIOPHARMA CO.LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"450","totalValueFC":"908.6","currency":"USD","unitRateINR":"38070","date":"27-Sep-2024","totalValueINR":"76140","totalValueInUsd":"908.6","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"5834857","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ADD:ROOM2603,RONG TAI\\'AN BUILDING NO.139 JINHUAI STREET,FENGZE ROAD, FENGZE DISTRICT,QUANZHOU CITY FUJIA CHINA","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730140200,"product":"VALGANCICLOVIR HCL PH.EUR","address":"B-1 EXTN. A\/27, MOHAN CO-OPERATIVE","city":"NEW DELHI,DELHI","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"PANACEA BIOTEC LIMITED","customerCountry":"INDIA","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"2442.6","totalValueFC":"17286.2","currency":"USD","unitRateINR":"207500","date":"29-Oct-2024","totalValueINR":"1452500","totalValueInUsd":"17286.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"6395984","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"B-1 EXTN. A\/27, MOHAN CO-OPERATIVE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

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ACTIVE PHARMA INGREDIENTS

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RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

7 DKSH

4 Faran Shimi Pharmaceutical

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8 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

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4 ACG Worldwide

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4 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

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1 Qualicaps

13 Roquette

1 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

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9 Sigachi Industries

3 Vasa Pharmachem

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