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Leo Pharma
FDA Orange Book

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

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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pharmacompass-1-m-2026-04-20

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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pharmacompass-2-m-2026-04-20

Leo Pharma

Contact Details

CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 266 News #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

38 All APIs, 32 USDMF, 13 CEP/COS, 1 JDMF, 1 KDMF

38 All APIs
32 USDMF
13 CEP/COS
1 JDMF
1 KDMF

DEVELOPMENTS

242 Drugs in Development

242 Drugs in Development

FINISHED DOSAGE FORMULATIONS

318 FDF Dossiers, 19 FDA Orange Book, 238 Europe, 32 Canada, 29 Australia

318 FDF Dossiers
19 FDA Orange Book
238 Europe
32 Canada
29 Australia

INSPECTIONS & REGISTRATIONS

17 FDA

17 FDA

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19 All

01 2AZELAIC ACID

02 3BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

03 1BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

04 3CALCIPOTRIENE

05 1DELGOCITINIB

06 1DESONIDE

07 2INGENOL MEBUTATE

08 2PINACIDIL

09 2TACROLIMUS

10 1TINZAPARIN SODIUM

11 1TRALOKINUMAB

filter Dosage Reset all filters

19 All

01 2AEROSOL, FOAM;TOPICAL

02 2CAPSULE, EXTENDED RELEASE;ORAL

03 2CREAM;TOPICAL

04 4GEL;TOPICAL

05 2INJECTABLE;INJECTION

06 4OINTMENT;TOPICAL

07 1SOLUTION;TOPICAL

08 2SUSPENSION;TOPICAL

filter Dosage Strength Reset all filters

19 All

01 20.005%

02 10.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

03 10.015%

04 10.03%

05 10.05%

06 10.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 40.064%;0.005%

08 10.1%

09 112.5MG

10 215%

11 1150MG/ML

12 12%

13 120,000 IU/ML

14 125MG

filter Regulatory Info Reset all filters

19 All

01 7DISCN

02 10RX

03 2Blank

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01

Brand Name : FINACEA

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Brand Name : FINACEA

RDD

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RLD : Yes

TE Code : AB

AZELAIC ACID

Dosage Form : GEL; TOPICAL

Proprietary Name : FINACEA

Dosage Strength : 15%

Approval Date : 2002-12-24

Application Number : 21470

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product
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02

Brand Name : FINACEA

RDD

Not Confirmed

Brand Name : FINACEA

RDD

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RLD : Yes

TE Code :

AZELAIC ACID

Dosage Form : AEROSOL, FOAM; TOPICAL

Proprietary Name : FINACEA

Dosage Strength : 15%

Approval Date : 2015-07-29

Application Number : 207071

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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03

Brand Name : TACLONEX

RDD

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Brand Name : TACLONEX

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RLD : Yes

TE Code : AB

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Dosage Form : OINTMENT; TOPICAL

Proprietary Name : TACLONEX

Dosage Strength : 0.064%;0.005%

Approval Date : 2006-01-09

Application Number : 21852

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product
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04

Brand Name : TACLONEX

RDD

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Brand Name : TACLONEX

RDD

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Digital Content

RLD : Yes

TE Code : AB

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Dosage Form : SUSPENSION; TOPICAL

Proprietary Name : TACLONEX

Dosage Strength : 0.064%;0.005%

Approval Date : 2008-05-09

Application Number : 22185

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

Brand Name : ENSTILAR

RDD

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Brand Name : ENSTILAR

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RLD : Yes

TE Code :

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Dosage Form : AEROSOL, FOAM; TOPICAL

Proprietary Name : ENSTILAR

Dosage Strength : 0.064%;0.005%

Approval Date : 2015-10-16

Application Number : 207589

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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06

Brand Name : TACLONEX

RDD

Not Confirmed

Brand Name : TACLONEX

RDD

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Digital Content

RLD :

TE Code :

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

Dosage Form : SUSPENSION; TOPICAL

Proprietary Name : TACLONEX

Dosage Strength : 0.064%;0.005%

Approval Date :

Application Number : 22185

RX/OTC/DISCN :

RLD :

TE Code :

Product
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07

Brand Name : DOVONEX

RDD

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Brand Name : DOVONEX

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RLD : Yes

TE Code : AB

CALCIPOTRIENE

Dosage Form : OINTMENT; TOPICAL

Proprietary Name : DOVONEX

Dosage Strength : 0.005%

Approval Date : 1993-12-29

Application Number : 20273

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product
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08

Brand Name : DOVONEX

RDD

Not Confirmed

Brand Name : DOVONEX

RDD

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RLD : Yes

TE Code : AB

CALCIPOTRIENE

Dosage Form : CREAM; TOPICAL

Proprietary Name : DOVONEX

Dosage Strength : 0.005%

Approval Date : 1996-07-22

Application Number : 20554

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

Brand Name : DOVONEX

RDD

Not Confirmed

Brand Name : DOVONEX

RDD

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RLD : Yes

TE Code :

CALCIPOTRIENE

Dosage Form : SOLUTION; TOPICAL

Proprietary Name : DOVONEX

Dosage Strength : 0.005% **Federal Registe...

Approval Date : 1997-03-03

Application Number : 20611

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
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10

Brand Name : ANZUPGO

RDD

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Brand Name : ANZUPGO

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RLD : Yes

TE Code :

DELGOCITINIB

Dosage Form : CREAM; TOPICAL

Proprietary Name : ANZUPGO

Dosage Strength : 2%

Approval Date : 2025-07-23

Application Number : 219155

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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1
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Contact Leo Pharma and get a quotation

Leo Pharma is a supplier offers 26 products (APIs, Excipients or Intermediates).

Find Sodium Fusidate bulk with CEP, JDMF offered by Leo Pharma

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Find FACILITIES AND OPERATING PROCEDURES IN BALLERUP, DENMARK bulk offered by Leo Pharma

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Find EB 1089 EC-CAPSULES DRUG PRODUCT bulk offered by Leo Pharma

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.