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Manufacturers & Suppliers of AM20070538 Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 5ALFRED E TIEFENBACHER GmbH & Co KG

02 5Strides Pharma Science

03 5Granules India Limited

04 2Anwita Drugs & Chemicals Pvt Ltd

05 5Ascent Innovative Medicines

06 2Ascent Pharmaceuticals

07 3Aspire Lifesciences Pvt Ltd

08 5Aurobindo Pharma Limited

09 2Bio Labs

10 5Biofarma Pharmaceutical Industry and Commerce Inc

11 3Dorsa Darou Pharmaceutical Company

12 2Globela Pharma

13 1Grupo Chemo

14 1Hanlim Pharmaceutical

15 5Intas Pharmaceuticals

16 3Ipca Laboratories Limited

17 3Jiangsu Hengrui Medicine Co., Ltd.

18 1Kusum Healthcare Pvt Ltd

19 2Lucent Biotech Ltd

20 5Madras Pharmaceuticals

21 2Mepaco Medifood

22 3Orbit Pharmaceuticals

23 5Pulse Pharmaceuticals

24 1RELIANCE FORMULATION PVT. LTD

25 2Raha Pharmaceutical Co

26 2Reyoung pharmaceutical

27 5TECNIMEDE

28 4World Medicine

29 3XL Laboratories Private Limited

30 1ZRS LABS

31 2Zim Laboratories

32 1Zota Healthcare Ltd

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PharmaCompass

01

  • 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 : US, ROW, CA

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW, CA

Registration Country : India

Granules India

01

  • 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 : US, ROW, CA

Gabapentin

Dosage : Immediate Release Caps...

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : Registered in EU

Gabapentin

Dosage : Capsule

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Gabapentin

Dosage : Capsule

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

04

  • 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 : US, ROW, CA

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW, CA

Registration Country : India

Granules India

04

  • 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 : US, ROW, CA

Gabapentin

Dosage : Immediate Release Caps...

Dosage Strength : 300MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

05

  • 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 : US, ROW, CA

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW, CA

Registration Country : India

Granules India

05

  • 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 : US, ROW, CA

Gabapentin

Dosage : Immediate Release Caps...

Dosage Strength : 400MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

06

  • 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

Gabapentin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

06

  • 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

Gabapentin

Dosage : Immediate Release Tabl...

Dosage Strength : 600MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

07

  • 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

Gabapentin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

07

  • 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

Gabapentin

Dosage : Immediate Release Tabl...

Dosage Strength : 800MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

08

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

08

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : Registered in EU

Gabapentin

Dosage : Capsule

Dosage Strength : 300MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

09

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

09

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : Registered in EU

Gabapentin

Dosage : Capsule

Dosage Strength : 400MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

10

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

Gabapentin

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

10

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : Registered in EU

Gabapentin

Dosage : Film Coated Tablet

Dosage Strength : 600MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

11

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Registered in EU

Registration Country : Germany

Gabapentin

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

11

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info : Registered in EU

Gabapentin

Dosage : Film Coated Tablet

Dosage Strength : 800MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

12

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

12

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Gabapentin

Dosage : Capsule

Dosage Strength : 300MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

13

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

13

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Gabapentin

Dosage : Capsule

Dosage Strength : 400MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

14

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

14

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Gabapentin

Dosage : Capsule

Dosage Strength : 600MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

15

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Gabapentin

Brand Name :

Dosage Form : Capsule

Dosage Strength : 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

15

  • fda
  • EDQM
  • WHO-GMP

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

Packaging :

Regulatory Info :

Gabapentin

Dosage : Capsule

Dosage Strength : 800MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

16

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Brand Name : NERVODIN®

Dosage Form : CAPSULE

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generics

Registration Country : Costa Rica

blank

16

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Dosage : CAPSULE

Dosage Strength : 300MG

Brand Name : NERVODIN®

Approval Date :

Application Number :

Registration Country : Costa Rica

blank

17

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Brand Name : Gabex

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 78428

Regulatory Info : Generic CTD, ACTD, BE

Registration Country : India

blank

18

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Brand Name : Gabex

Dosage Form : CAPSULE

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number : 78428

Regulatory Info : Generic CTD, ACTD, BE

Registration Country : India

blank

19

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Brand Name : Gabex

Dosage Form : CAPSULE

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 78428

Regulatory Info : Generic CTD, ACTD, BE

Registration Country : India

blank

20

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Brand Name : NUROPENTINE

Dosage Form : CAPSULE

Dosage Strength : 300MG

Packaging : Alu-PVC/PVDC Blister Pack

Approval Date :

Application Number : 78428

Regulatory Info : Generic

Registration Country : India

blank

20

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

Gabapentin

Dosage : CAPSULE

Dosage Strength : 300MG

Brand Name : NUROPENTINE

Approval Date :

Application Number : 78428

Registration Country : India

blank