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

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01 3Rusan Pharma

02 3Octavius Pharma Pvt. Ltd

03 2Strides Pharma Science

04 4A&M Therapy

05 4AAIPharma Services Corp.

06 2ANDA Repository

07 5ANI Pharmaceuticals Inc

08 3Abcuro, Inc

09 6Accord healthcare

10 24Actavis Inc

11 3Advanz Pharma

12 6AiPing Pharmaceutical Inc

13 1Aldo-Union

14 4Apotex Inc

15 7AstraZeneca

16 6Aurobindo Pharma Limited

17 2Avet Pharmaceuticals

18 2Bausch Health

19 4Bayer AG

20 4Biodeal Pharmaceuticals

21 5Bristol Myers Squibb

22 6CENTAUR PHARMS PVT

23 8Chartwell Pharmaceuticals llc

24 6Copley Scientific

25 4DMFs Not Supported

26 6ENDO OPERATIONS

27 7F. Hoffmann-La Roche

28 5Fosun Pharmaceutical

29 4H. Lundbeck AS

30 6HALSEY

31 1Halewood Laboratories Pvt. Ltd

32 4Hiral Labs

33 1IST.GANASSINI SpA

34 5IVAX Pharmaceuticals Inc

35 4JAMP PHARMA

36 2Kiara Health

37 2Kwality Pharmaceuticals

38 11Leading Pharma, LLC

39 4MARCAN PHARMACEUTICALS INC

40 6Mankind Pharma

41 2Micro Labs Limited

42 8Mutual Pharmaceutical Company, Inc.

43 5New River Pharmaceuticals

44 2ORIFARM GROUP AS

45 3PRO DOC LIMITEE

46 10PUREPAC PHARM

47 11Par Pharmaceutical

48 7Pharmascience Inc.

49 6Pliva Hrvatska

50 1Poddar Pharmaceuticals

51 6RELIANCE FORMULATION PVT. LTD

52 6RISING PHARMA

53 12ROXANE

54 6Rubicon Research

55 5SUPERPHARM

56 7Sandoz B2B

57 16Sun Pharmaceutical Industries Limited

58 1TEOFARMA Srl

59 10Teva Pharmaceutical Industries

60 1Trends Pharma

61 6UCB Pharma S.A

62 3USL PHARMA

63 1Umedica Laboratories

64 6Unichem Pharmaceuticals USA, Inc

65 17Viatris

66 6Warner Chilcott Company, LLC

67 2West-ward Pharmaceutical Corp

68 3Wockhardt

69 1XL Laboratories Private Limited

70 6Zim Laboratories

71 2Zota Healthcare Ltd

72 6Zydus Pharmaceuticals

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PharmaCompass

01

  • 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

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging : Pack Size 10x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

02

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : Generic

Registration Country : South Africa

Amitriptyline Hydrochloride

Brand Name : Amderip 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

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

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25mg

Packaging : Pack Size 10x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

05

  • 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

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 10mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

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 : DMF Available|FDF Compliance-USP

Registration Country : India

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

07

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Amitriptyline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : Generic

Registration Country : South Africa

Amitriptyline Hydrochloride

Brand Name : Amderip 25

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

09

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG

Packaging :

Approval Date : 2021-09-29

Application Number : 212654

Regulatory Info : RX

Registration Country : USA

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10

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2021-09-29

Application Number : 212654

Regulatory Info : RX

Registration Country : USA

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11

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2021-09-29

Application Number : 212654

Regulatory Info : RX

Registration Country : USA

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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13

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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14

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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15

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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16

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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17

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : ELAVIL

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 12703

Regulatory Info : DISCN

Registration Country : USA

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18

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-02-19

Application Number : 213999

Regulatory Info : RX

Registration Country : USA

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19

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2021-02-19

Application Number : 213999

Regulatory Info : RX

Registration Country : USA

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AMITRIPTYLINE HYDROCHLORIDE

Brand Name : AMITRIPTYLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2021-02-19

Application Number : 213999

Regulatory Info : RX

Registration Country : USA

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