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List of All Manufacturers & Suppliers of Terbinafine Hydrochloride Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 2Sanofi

02 2Aspen Pharmacare Holdings

03 1Dr. Reddy's Laboratories

04 1Rusan Pharma

05 1Taro Pharmaceutical Industries

06 1Breckenridge Pharmaceutical

07 1Octavius Pharma Pvt. Ltd

08 1ANDRX LABS LLC

09 2Acino Pharma (Pty) Ltd

10 3Actavis Inc

11 2Activo Health

12 1Akriti Pharmaceuticals Pvt. Ltd.

13 1Apofri AB

14 1Apotex Inc

15 1Auro Pharma Inc

16 2Aurobindo Pharma Limited

17 1Avet Pharmaceuticals

18 2Axapharm

19 2Bio Labs

20 2Biofarma Pharmaceutical Industry and Commerce Inc

21 1Bluefish Pharmaceuticals AB

22 1Chartwell Pharmaceuticals llc

23 1Chongqing Huapont Pharmaceutical

24 1Cipla

25 1Cross Pharma AB

26 2DOC Generici

27 1Dermapharm AG

28 3Drossapharm

29 2EG SpA

30 1Emed Medical Company

31 1Fitopharm

32 1Flagship Biotech International Pvt. Ltd

33 5GSK

34 1Gedeon Richter

35 2Gia Nguyen Pharmaceutical

36 1Glenmark Pharmaceuticals

37 1Gujarat Pharma Lab

38 1Hexal AG

39 2IVAX Pharmaceuticals Inc

40 1InvaGen Pharmaceuticals Inc

41 4Karo Pharma

42 2Kolmar Korea Co., Ltd.

43 3LPB IST.FARMACEUTICO Srl

44 2Laboratoires Bailleul

45 1Laboratorios Alter

46 1Madras Pharmaceuticals

47 1Medartuum AB

48 3Mepha Pharma

49 2Meracine

50 1Myungmoon Pharm. Co., LTD.

51 1NOVARTIS ANIMAL HEALTH CANADA INC

52 1Natco Pharma

53 4Nobel Ilac Sanayii Ve Ticaret A.S.

54 10Novartis Pharmaceuticals Corporation

55 10ORIFARM GROUP AS

56 1OrBion Pharmaceuticals

57 1PRO DOC LIMITEE

58 3Paranova Group AS

59 3Pharmascience Inc.

60 1ROXANE

61 1S.F.GROUP Srl

62 1SANIS HEALTH INC

63 1SIVEM PHARMACEUTICALS ULC

64 2STADA Arzneimittel

65 10Sandoz B2B

66 1Seoul Pharma Co Ltd

67 1TECNIGEN Srl

68 3Teva Pharmaceutical Industries

69 1Vaishali Pharma Ltd

70 1Valley Medical AB,

71 3Viatris

72 1Wockhardt

73 1World Medicine

74 2ZRS LABS

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PharmaCompass

01

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Terbinafinum

Brand Name : Terbinafin Zentiva

Dosage Form : Tab

Dosage Strength : 250mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

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AAPS 2024
Not Confirmed

Terbinafine Hydrochloride

Brand Name : Terbicil 1% Cream

Dosage Form : CRE

Dosage Strength : 10mg/g

Packaging : 7.5X1mg/g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

03

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : RX

Registration Country : USA

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Packaging :

Approval Date : 2007-07-02

Application Number : 76390

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

Regulatory Info :

Registration Country : India

Terbinafine Hydrochloride

Brand Name :

Dosage Form : Cream

Dosage Strength : 1%/w/v

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

05

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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Packaging :

Approval Date : 2010-06-04

Application Number : 77714

Regulatory Info : RX

Registration Country : USA

Breckenridge Pharmaceutical

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Terbinafine Hydrochloride

Brand Name :

Dosage Form : Ointment

Dosage Strength : 1%/w/w

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

07

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Terbinafinum

Brand Name : Terbinafin Zentiva

Dosage Form : Tab

Dosage Strength : 250mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

08

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AAPS 2024
Not Confirmed

Terbinafine Hydrochloride

Brand Name : Terbicil 1% Cream

Dosage Form : CRE

Dosage Strength : 10mg/g

Packaging : 15X1mg/g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

09

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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1%

Packaging :

Approval Date : 2007-07-02

Application Number : 77511

Regulatory Info : OTC

Registration Country : USA

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Dosage Strength : EQ 250MG BASE

Packaging :

Approval Date :

Application Number : 76713

Regulatory Info :

Registration Country : USA

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11

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Packaging :

Approval Date : 2007-07-02

Application Number : 76377

Regulatory Info : DISCN

Registration Country : USA

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12

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Packaging :

Approval Date : 2007-07-02

Application Number : 77065

Regulatory Info : DISCN

Registration Country : USA

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13

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Packaging :

Approval Date : 1997-10-17

Application Number : 20749

Regulatory Info : DISCN

Registration Country : USA

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14

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1%

Packaging :

Approval Date : 1999-03-09

Application Number : 20980

Regulatory Info : OTC

Registration Country : USA

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15

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL AT

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Packaging :

Approval Date : 2000-03-17

Application Number : 21124

Regulatory Info : OTC

Registration Country : USA

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16

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL AT

Dosage Form : SPRAY;TOPICAL

Dosage Strength : 1%

Packaging :

Approval Date : 2000-03-17

Application Number : 21124

Regulatory Info : OTC

Registration Country : USA

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17

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-12-30

Application Number : 20192

Regulatory Info : DISCN

Registration Country : USA

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18

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : TABLET;ORAL

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

Packaging :

Approval Date : 1996-05-10

Application Number : 20539

Regulatory Info : DISCN

Registration Country : USA

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19

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 125MG BASE/PACKET

Packaging :

Approval Date : 2007-09-28

Application Number : 22071

Regulatory Info : DISCN

Registration Country : USA

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20

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 187.5MG BASE/PACKET

Packaging :

Approval Date : 2007-09-28

Application Number : 22071

Regulatory Info : DISCN

Registration Country : USA

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