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Manufacturers & Suppliers of Sertraline Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 2ALFRED E TIEFENBACHER GmbH & Co KG

02 6Octavius Pharma Pvt. Ltd

03 3Granules India Limited

04 3Ascent Pharmaceuticals

05 2Aurobindo Pharma Limited

06 2Bio Labs

07 2Biofarm

08 4Biofarma Pharmaceutical Industry and Commerce Inc

09 2Dorsa Darou Pharmaceutical Company

10 2Grupo Azevedos

11 3Intas Pharmaceuticals

12 2Ipca Laboratories Limited

13 3Lucent Biotech Ltd

14 1Pluviaendo

15 3RELIANCE FORMULATION PVT. LTD

16 2Ria Generics

17 2Smith & Kenner Pharmaceuticals

18 2TECNIMEDE

19 2Umedica Laboratories Pvt Ltd

20 2XL Laboratories Private Limited

21 2Zentiva

22 1Zota Healthcare Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : Registered in EU

Registration Country : Germany

Sertraline Hydrochloride

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Packaging :

Regulatory Info : Registered in EU

Sertraline Hydrochloride

Dosage : Film Coated Tablet

Dosage Strength : 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

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 :

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Sertraline Hydrochloride

Dosage : Tablet

Dosage Strength : 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

03

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : ROW, US

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : ROW, US

Sertraline Hydrochloride

Dosage : Immediate Release Tabl...

Dosage Strength : 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : Registered in EU

Registration Country : Germany

Sertraline Hydrochloride

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Packaging :

Regulatory Info : Registered in EU

Sertraline Hydrochloride

Dosage : Film Coated Tablet

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

05

  • 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

Sertraline Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

05

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Sertraline Hydrochloride

Dosage : Tablet

Dosage Strength : 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius 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 :

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

06

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Sertraline Hydrochloride

Dosage : Tablet

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

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-U...

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-U...

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.

Packaging :

Regulatory Info : DMF Available|FDF Compliance-U...

Sertraline Hydrochloride

Dosage : DC Granules

Dosage Strength : 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

08

  • 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-U...

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

Octavius Pharma

08

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : DMF Available|FDF Compliance-U...

Sertraline Hydrochloride

Dosage : DC Granules

Dosage Strength : 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

09

  • 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-U...

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

Octavius Pharma

09

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : DMF Available|FDF Compliance-U...

Sertraline Hydrochloride

Dosage : DC Granules

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

10

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : ROW, US

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

10

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : ROW, US

Sertraline Hydrochloride

Dosage : Immediate Release Tabl...

Dosage Strength : 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

11

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : ROW, US

Registration Country : India

Sertraline Hydrochloride

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

11

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : ROW, US

Sertraline Hydrochloride

Dosage : Immediate Release Tabl...

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

12

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : Biosert

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging : 3 x 10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

blank

12

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 50MG

Brand Name : Biosert

Approval Date :

Application Number :

Registration Country : Pakistan

blank

13

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : Biosert

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 2 x 10's; 3 x 10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

blank

13

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 100MG

Brand Name : Biosert

Approval Date :

Application Number :

Registration Country : Pakistan

blank

14

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : Inosert

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 19839

Regulatory Info : Generic CTD, ACTD, BE

Registration Country : India

blank

15

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : Inosert

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 19839

Regulatory Info : Generic CTD, ACTD, BE

Registration Country : India

blank

16

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : UTRALENE

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging : Blister of 10s

Approval Date :

Application Number : 19839

Regulatory Info : Generic

Registration Country : India

blank

16

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 50MG

Brand Name : UTRALENE

Approval Date :

Application Number : 19839

Registration Country : India

blank

17

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : UTRALENE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : Blister of 10s

Approval Date :

Application Number : 19839

Regulatory Info : Generic

Registration Country : India

blank

17

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 100MG

Brand Name : UTRALENE

Approval Date :

Application Number : 19839

Registration Country : India

blank

18

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : PASERT

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 19839

Regulatory Info : Generic

Registration Country : India

blank

18

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 100MG

Brand Name : PASERT

Approval Date :

Application Number : 19839

Registration Country : India

blank

19

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name : PASERT

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 19839

Regulatory Info : Generic

Registration Country : India

blank

19

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 50MG

Brand Name : PASERT

Approval Date :

Application Number : 19839

Registration Country : India

blank

20

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Brand Name :

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

blank

20

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Sertraline Hydrochloride

Dosage : TABLET

Dosage Strength : 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank