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DENTSPLY PHARM
FDF Dossiers

AMI Lifesciences is Driven by Chemistry. Powered by People.

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

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Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.

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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

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Quotient Sciences- Molecule to Cure. Fast.

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pharmacompass-2-m-2025-08-25

DENTSPLY PHARM

Contact Details

CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 45 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
45 News #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 9 FDA Orange Book, 12 Europe, 14 Canada

35 FDF Dossiers
9 FDA Orange Book
12 Europe
14 Canada

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filter Active Ingredients Reset all filters

35 All

01 2ARTICAINE HYDROCHLORIDE

02 2EPINEPHRINE

03 3EPINEPHRINE (EPINEPHRINE BITARTRATE)

04 1EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

05 1EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

06 2EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

07 1Flera substanser, se innehåll

08 1LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

09 1LIDOCAINE

10 3LIDOCAINE HYDROCHLORIDE

11 1LIDOCAINE; PRILOCAINE

12 2Lidocaine

13 1Lidocaine; Prilocaine

14 2MEPIVACAINE HYDROCHLORIDE

15 2Mepivacaine

16 1Mepivacaine hydrochloride

17 1PRILOCAINE

18 3PRILOCAINE HYDROCHLORIDE

19 2Prilocaine

20 2Several substances refer to content

21 1mepivacaine

filter Applicant Reset all filters

35 All

01 14DENTSPLY CANADA LIMITED

02 1DENTSPLY ITALIA Srl

03 9DENTSPLY PHARM

04 1Dentsply DeTrey GmbH

05 2Dentsply Limited

06 4Dentsply Limited,

07 4Dentsply Ltd

filter Dosage Form Reset all filters

35 All

01 2GEL

02 1GEL;PERIODONTAL

03 8INJECTABLE;INJECTION

04 6Injection fluid, resolution

05 1LIQUID

06 1PERIODONTALGEL

07 11SOLUTION

08 3SOLUTION FOR INJECTION

09 1Solution for injection

10 1Blank

filter Dosage Reset all filters

35 All

01 1--

02 20.005MG/ML

03 10.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

04 10.005MG/ML;4%

05 20.01MG/ML

06 10.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 10.02MG/ML

08 10.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

09 10.05MG/ML;2%

10 12%

11 22.5%

12 12.5%;2.5%

13 120 MG / ML + 12

14 220 mg/ml/12.5 mcg/ml

15 220MG/ML

16 13%

17 130 MG / ML

18 130 MG / ML + 0

19 330 mg/ml

20 230 mg/ml/0.03 IE/ml

21 130MG/ML

22 14%

23 440MG/ML

24 1Periodontal Gels 20 Cart 1.7 G 25 Mg/G + 25 Mg/G

filter Country Reset all filters

35 All

01 14Canada

02 1Italy

03 7Norway

04 4Sweden

05 9USA

List of Suppliers

Supplier Virtual Booth

price-trend

01

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

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U.S.A

Digital Content

Regulatory Info :

Registration Country : Canada

ARTICAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 40MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248488

Regulatory Info :

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

02

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

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U.S.A

Digital Content

Regulatory Info :

Registration Country : Canada

ARTICAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 40MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248489

Regulatory Info :

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

03

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

iPHEX India

Not Confirmed

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

iPHEX India

Not Confirmed

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U.S.A

Digital Content

Regulatory Info :

Registration Country : Canada

EPINEPHRINE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : XYLOCAINE DENTAL LIDOCAIN...

Dosage Strength : 0.01MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2331640

Regulatory Info :

Registration Country : Canada

Product
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04

Brand Name : 4% CITANEST FORTE DE...

U.S.A

iPHEX India

Not Confirmed

Brand Name : 4% CITANEST FORTE DE...

U.S.A

iPHEX India

Not Confirmed

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U.S.A

Digital Content

Regulatory Info :

Registration Country : Canada

EPINEPHRINE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% CITANEST FORTE DENTAL ...

Dosage Strength : 0.005MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2347695

Regulatory Info :

Registration Country : Canada

Product
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05

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 0.01MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248488

Regulatory Info :

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

iPHEX India

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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U.S.A

Digital Content

Regulatory Info :

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 0.005MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248489

Regulatory Info :

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

07

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

iPHEX India

Not Confirmed

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

iPHEX India

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : XYLOCAINE DENTAL LIDOCAIN...

Dosage Strength : 0.02MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2345072

Regulatory Info :

Registration Country : Canada

Product
Web Link

Stock Recap
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08

Brand Name : DURANEST

U.S.A

iPHEX India

Not Confirmed

Brand Name : DURANEST

U.S.A

iPHEX India

Not Confirmed

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U.S.A

Digital Content

Regulatory Info : DISCN

Registration Country : USA

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : DURANEST

Dosage Strength : 0.005MG/ML;1.5% **Fede...

Packaging :

Approval Date : 1982-01-01

Application Number : 21384

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

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09

Brand Name : CITANEST FORTE DENTA...

U.S.A

iPHEX India

Not Confirmed

Brand Name : CITANEST FORTE DENTA...

U.S.A

iPHEX India

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : CITANEST FORTE DENTAL

Dosage Strength : 0.005MG/ML;4%

Packaging :

Approval Date : 1982-01-01

Application Number : 21383

Regulatory Info : RX

Registration Country : USA

Product
Web Link

Stock Recap
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10

Brand Name : XYLOCAINE DENTAL WIT...

U.S.A

iPHEX India

Not Confirmed

Brand Name : XYLOCAINE DENTAL WIT...

U.S.A

iPHEX India

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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U.S.A

Digital Content

Regulatory Info : DISCN

Registration Country : USA

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : XYLOCAINE DENTAL WITH EPI...

Dosage Strength : 0.01MG/ML;2% **Federal...

Packaging :

Approval Date : 1982-01-01

Application Number : 21381

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

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