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01 1Orion Corporation

02 3ABC FARMACEUTICI SPA

03 5ABC FARMACEUTICI SpA

04 1ABC Farmaceutici S.P.A.

05 2AESCULAPIUS FARMACEUTICI SRL

06 1ANGENERICO SpA

07 1AUROBINDO PHARMA ITALIA SRL

08 1AUROBINDO PHARMA ITALIA Srl

09 1Aesculapius Pharmaceuticals Srl

10 1As Grindeks

11 1Aurobindo Pharma (Malta) Limited

12 8CHEPLAPHARM ARZNEIMITTEL GMBH

13 2CRINOS SpA

14 5Central Procurement & Supplies Unit

15 4Cheplapharm Schweiz Gmbh

16 2DOC GENERICI SRL

17 2DOC GENERICI Srl

18 3Dr. Falk Pharma Ag

19 4Dr. Falk Pharma GmbH

20 3EG SPA

21 2EG SpA

22 4ERREKAPPA EUROTERAPICI SpA

23 3Estedi Laboratory Sl

24 1FRANCIA FARMAC.IND.FAR.BIO.Srl

25 3Glenmark Arzneimittel Gmbh

26 1Gm Pharmaceuticals Ltd.

27 1Grindeks As

28 2Grindeks Sa

29 4I.B.I.GIOVANNI LORENZINI SpA

30 2I.B.N. SAVIO Srl

31 3ITALIAN BIOCHEMISTRY INSTITUTE GIOVANNI LORENZINI SPA

32 3Kusum Pharm Srl

33 2MAGIS FARMACEUTICI Srl

34 2MYLAN SPA

35 2MYLAN SpA

36 2NATIONAL BIOCHEMISTRY INSTITUTE SAVIO SRL

37 1NM Pharma Limited

38 1Nobel Ilac Pazarlama Ve Sanayii Ltd. ?ti

39 1Nobel Ilac Sanayii Ve Ticaret A.S.

40 1Nordic Prime Aps

41 1OTIFARMA Srl

42 5Orifarm AS

43 3Orifarm Generics A/S

44 2Pharmaceutical Innovation Services Sl

45 1Pharmactive ilac

46 9Pro.Med.Cs Prague As

47 2Pro.Med.Cs Praha A.S.

48 2Pro.Med.Cs Praha As

49 1Prohealth Limited

50 4RATIOPHARM GMBH

51 3S.F.GROUP Srl

52 4SF GROUP SRL

53 2SO.SE.PHARM SRL

54 2SO.SE.PHARM Srl

55 3Vefa Ilac

56 3World Medicine Ilac San.Ve Tic. A.?.

57 1ZAMBON ITALIA SRL

58 3ZAMBON ITALIA Srl

59 2ZENTIVA ITALIA Srl

60 1Zambon Sau

61 2Zambon Switzerland Sa

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PharmaCompass

01

Ursodeoxycholic Acid

Brand Name : Ursodeoxycholsyre \"Orion\"

Dosage Form : Hard Capsules

Dosage Strength : 250mg

Packaging :

Approval Date : 11-09-2017

Application Number : 28105897916

Regulatory Info : Prescription

Registration Country : Denmark

Fermion Orion Company Banner

02

ASPEN
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Ursodeoxycholic Acid

Brand Name : Ursobil

Dosage Form : Ursodeoxycholic Acid 300Mg 20 Joined' Oral Use

Dosage Strength : 20 CPR 300 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

ASPEN
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Ursodeoxycholic Acid

Brand Name : Ht Ursobil

Dosage Form : Ursodeoxycholic Acid 450Mg 20 Joined' Oral Use

Dosage Strength : 20 cps 450 mg controlled release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ASPEN
Not Confirmed
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ASPEN
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Ursodeoxycholic Acid

Brand Name : Ursobil

Dosage Form : Ursodeoxycholic Acid 150Mg 20 Joined' Oral Use

Dosage Strength : 20 cps 150 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

ASPEN
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ASPEN
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Ursodeoxycholic Acid

Brand Name : Ursobil

Dosage Form : Ursodeoxycholic Acid 250Mg 20 Joined' Oral Use

Dosage Strength : 20 cps 250 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

ASPEN
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ASPEN
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Ursodeoxycholic Acid

Brand Name : Ursobil

Dosage Form : Ursodeoxycholic Acid 3% 200Ml Oral Use

Dosage Strength : syrup 1 Bottle 200 ml 3 g/100 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

ASPEN
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ASPEN
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Ursodeoxycholic acid

Brand Name : URSOBIL

Dosage Form : Hard Capsules

Dosage Strength : 150 mg

Packaging : 20 UNITS 150 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

ASPEN
Not Confirmed
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ASPEN
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Ursodeoxycholic acid

Brand Name : URSOBIL

Dosage Form : Tablets

Dosage Strength : 300 mg

Packaging : 20 UNITS 300 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

ASPEN
Not Confirmed
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ASPEN
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Ursodeoxycholic acid

Brand Name : URSOBIL HT

Dosage Form : Modified Release Hard Capsules

Dosage Strength : 450 mg

Packaging : 20 UNITS 450 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

ABC Farmaceutici S.P.A.

Country
ASPEN
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ABC Farmaceutici S.P.A.

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ASPEN
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Ursodeoxycholic Acid

Brand Name : Ursobil

Dosage Form : Hard Capsule

Dosage Strength : 250MG

Packaging :

Approval Date : 2025-06-26

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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